Food and Drug Administration

The first coronavirus vaccines could be approved before the November election - news - Sparklight | 6/22/2020

… results might be ready at some point this fall for some of the potential COVID-19 prophylactics, and they may be authorized for emergency use before the end of 2020. Jefferies analysts believe the Food and Drug Administration could approve some of the vaccines before the November presidential elections. The news will be bullish for the economy and the market, and it could improve Trump’s chances of winning reelection. The …

FDA, CDC: Bagged salad possibly linked to intestinal parasite illness, multistate investigation underway | FOX6Now.com | 6/22/2020

ATLANTA — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced on June 19 an investigation is underway for a multistate outbreak of an illness caused by an intestinal parasite that may be linked to bagged salad that is sold in ALDI, Hy-Vee and Jewel-Osco grocery stores. Cyclospora is an intestinal illness caused by a microscopic parasite, according to the CDC …

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2020 Democratic party issues | 6/22/2020

… people who make lifestyle choices and practice aberrant behavior as a protected class of citizens. The Progressive experiment with our children has led to 6,370 deaths from the hormone blocker Lupron, according to the Food and Drug Administration (FDA). [34] “Between 2012 and June 30 of this year, the FDA documented over 40,764 adverse reactions suffered by patients who took Leuprolide Acetate (Lupron), which is used as a hormone blocker …

China to temporarily suspend poultry imports from Springdale Tyson plant due to COVID-19 outbreak | 6/22/2020

… WE PRODUCE ALL OF OUR FOOD IN FULL COMPLIANCE WITH GOVERNMENT SAFETY REQUIREMENTS. IT IS IMPORTANT TO NOTE THAT THE WORLD HEALTH ORGANIZATION THE CENTERS FOR DISEASE CONTROL AND PREVENTION USDA AND THE US FOOD AND DRUG ADMINISTRATION AGREED THAT NO EVIDENCE TO SUPPORT TRANSMISSION OF COVID-19 ASSOCIATED WITH FOOD YESTERDAY BENSON RAMOS PROTESTED IN MARCH TO THE TYSON TECHNOLOGY CENTER IN SPRINGDALE. THE DIRECTOR OF THE GROUP IS …

China suspends US poultry imports from Covid-19-affected business | World news | The Guardian | 6/22/2020

… safety requirements. Anxiety in Beijing as officials battle new coronavirus outbreak Read more “It is important to note that the World Health Organization, the Centers for Disease Control and Prevention, USDA and the US Food and Drug Administration agree that there is no evidence to support transmission of Covid-19 associated with food,” he said in an email. China also suspended pork products from German pork processor Toennies last week …

Urgent care centers champion antibody tests, as state officials urge caution | 6/22/2020

… appear after about seven days and disappear after a few weeks. A second type, IgG antibodies, appear after 14 days and are likely to provide longer-term immunity — though how long remains unclear . The Food and Drug Administration issued emergency approval for the tests in early April, but the initial enthusiasm around the tests diminished as more research emerged; The New York Times reported that only three of the original …

Despite FDA approval, Massachusetts nurses say N95 decontamination process is unproven | 6/22/2020

… Morse Hospital in Natick, said in a statement to the Daily News that it is using the Battelle system to reuse N95 masks. The medical center noted the system is approved by the U.S. Food and Drug Administration . “In an effort to act responsibly with our supplies, we are following the U.S. Centers for Disease Control (CDC) recommendation on the reprocessing of N95 respirators,” the hospital’s statement reads. “Like other …

Coronavirus Live News: World Updates - iJournalNews | 6/22/2020

… confirmed cases were not simply a result of increased testing. Pointing to increased hospitalizations, he said,“That’s a real rise.” On “Face the Nation” on CBS, Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration , said , “We’re seeing the positivity rates go up. That’s a clear indication there is now community spread underway, and this isn’t just a function of testing more.” Dr. Michael Osterholm, the director …

Skadden Discusses Significant Ninth Circuit Ruling on Scienter in Securities Fraud | 6/22/2020

… v. Endologix, Inc., No. 18-56322, 2020 WL 3069776 (9th Cir. June 10, 2020), held that the plaintiff’s theory that a medical device manufacturer misled investors about its product’s prospects for approval by the U.S. Food and Drug Administration (FDA) was too illogical to support the strong inference of scienter required to state a securities fraud claim. In doing so, the court held that lower courts should carefully scrutinize the economic …

ASP Scan (Weekly) for Jun 19, 2020 | 6/22/2020

… Natural Resources Defense Council (NRDC) and the Center for Disease Dynamics, Economics & Policy (CDDEP) shows that cattle and swine on US farms consume 44% more of medically important antibiotics than do humans. Using 2018 Food and Drug Administration data on sales of antibiotics for food-producing animals and 2017 data on sales of antibiotics for use in humans obtained from the IQVIA pharmaceutical database by CDDEP, the analysis found that …

Dirty hands, dripping pipes and illegal labeling spur warning from FDA | 6/22/2020

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. Cali Rice Valley Inc. San Francisco …

Recall alert: Publix recalls some of its salad products in multiple states | 6/22/2020

Publix announced Sunday that Fresh Express has voluntarily recalled some of its salads sold in the Lakeland, Florida-based grocery giant’s stores. According to the U.S. Food and Drug Administration , the 11.5-ounce Southwest Chopped Kit with production codes G163B10A and G163B10B; UPC code 071279306025; and had a use-by date of June 29 have been recalled. The products are being recalled due to undeclared wheat, soy, cashews and coconuts …

Tulsa Pop? Is Trump A One Termer? | 6/22/2020

… a second COVID wave and improving [economic] data.” On Sunday, WHO reported more than 183,000 new cases in the latest 24 hours, with Brazil and the U.S. having the most new cases. Former U.S. Food and Drug Administration chief Scott Gottlieb told CBS News on Sunday and more states need to mandate the use of face masks in public in an effort to slow the spread of the disease. “It’s …

Sassafras | 6/22/2020

… That equates to a dose of about 3 mg of safrole per 1 kg of body weight. This is about 4.5 times the dose that researchers think is poisonous. So, in 1976, the US Food and Drug Administration (FDA) ruled that sassafras could no longer be sold as sassafras tea. The poison story comes from studies in the 1960s which suggested that safrole was carcinogenic, causing permanent liver damage in …

Calorie data on menus could generate significant health, economic benefits | 6/22/2020

… cases of cardiovascular diseases, including 1,575 deaths and 21,522 Type 2 diabetes cases, the modeling study estimates. The findings were published in the American Heart Association’s journal Circulation: Cardiovascular Quality and Outcomes. Pubblicità The Food and Drug Administration in May 2018 began mandating that calories be listed on menus and menu boards of restaurants that are part of a chain of 20 or more locations. On April 1, the agency …

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain | Benzinga | 6/22/2020

U.S. commercialization expected to begin in the first half of 2021 Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021 Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8 ® , its implantable neurostimulation system to treat intractable chronic low back pain. Jason …

FSD Pharma Reports Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultramicronized PEA | Business Wire | 6/22/2020

… Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19,” continued Dr. Bokhari. “The U.S. Food and Drug Administration recently gave the Company permission to submit an Investigational New Drug application for the use of FSD201 to treat COVID-19. We contacted the FDA after becoming aware that Italian physicians and …

US coronavirus deaths near 120,000: Live updates | 6/22/2020

A former US Food and Drug Administration commissioner has warned that some US states, including Texas, Florida and Arizona, could start to see an “exponential” rise in coronavirus cases this coming week. Commissioner Scott Gottlieb sounded the alarm as the US death toll hit 119,959, according to the Johns Hopkins University tally. The World Health Organization reported a record increase in global coronavirus cases, with the total rising by 183,020 …

coronavirus news | 6/22/2020

… don’t think we’re going to see one, two and three waves. I think we’re just going to see one very, very difficult forest fire of cases. Dr Scott Gottlieb, a former commissioner of the Food and Drug Administration , noted on CBS Face the Nation: We’re seeing the positivity rates go up. That’s a clear indication there is now community spread underway, and this isn’t just a function of testing more …

Robert F. Kennedy Jr., on coming COVID vaccines | 6/22/2020

… that we’ve gotten out to basically the entire world.” On April 17, 2020, the chairman of the United States Conference of Catholic Bishops sent an open letter to Dr. Stephen Hahn, Commissioner of the Food and Drug Administration , urging the FDA to ensure that vaccines for COVID-19 be developed ethically and free from any connection to the exploitation of abortion victims. In this unprecedented time, I reached out to …

U.S.: Cyclospora outbreak linked to bagged salads from three supermarkets | 6/22/2020

U.S.: Cyclospora outbreak linked to bagged salads from three supermarkets June 22 , 2020 A A A Bagged salad products have been recalled from numerous retailers in the U.S. after they were linked to a multi-state outbreak of Cyclospora. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control (CDC) believe the outbreak is linked to certain store brand ‘Garden Salad Mix’ products from Hy-Vee, ALDI and …

Taiwanese startup Deep01 raises $2.7 million for its AI-based medical imaging software | TechCrunch | 6/22/2020

… CT brain scans more quickly, announced today that it has raised $2.7 million. The funding was led by PC maker ASUSTek. Deep01’s product has obtained clearance from both Taiwan and the United States’ Food and Drug Administration s, and the company received its first purchase order, worth about $700,000, in February. Other investors included the Digital Economy Fund, which is co-funded by Taiwanese research organizations Industrial Technology Research Institute …

Taiwanese AI healthtech startup bags $2.7m in Asus-led round | 6/22/2020

… stroke – for accident and emergency (A&E) departments with an accuracy of 93% to 95% at 30 seconds per case. Deep01 claims to be the first AI company in Asia Pacific to obtain US Food and Drug Administration (FDA) clearances in July 2019. Its technology also won approval from Taiwan’s FDA in February this year. What problem is it solving? Stroke and brain trauma, which are commonly seen in A …

FDA Granted Accelerated Approval to Tazemetostat for Follicular Lymphoma | 6/22/2020

FDA also approved the cobas EZH2 Mutation Test as a companion diagnostic for tazemetostat Date: Topics: Anticancer agents & Biologic therapy; Haematologic malignancies; Personalised medicine On 18 June 2020, the US Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumours are positive for an EZH2 mutation as detected by an …

Aldi, Hy-Vee and Jewel-Osco Are Working With FDA to Stem Store Brand Illness Outbreak | Retail Leader | 6/22/2020

FDA assisting on store brand salad recalls FDA assisting on store brand salad recalls By Mike Troy - 06/22/2020 Subscribe The Food and Drug Administration said it is working with Hy-Vee, Aldi and the Jewel-Osco division of Albertsons to determine sourcing of store brand garden salads following 76 reported illnesses and 16 hospitalizations. “The U.S. Food and Drug Administration , along with the Centers for Disease Control and Prevention and …

NIH

Three decades before coronavirus, Anthony Fauci took heat from AIDS protesters | 5/20/2020

… the National Institutes of Health in Bethesda on May 21, 1990. With signs that read, “Red Tape Kills Us,” and “NIH — Negligence, Incompetence and Horror,” the AIDS activists marched toward a row of police officers … and homophobia flourished, ACT UP staged theatrical protests at the Food and Drug Administration, on Wall Street and at New York’s City Hall. The most famous was a 1989 die-in at New York’s St …

American Heart Association

AngioSoma’s Development of Atherectomy Catheter | 5/20/2020

Food and Drug Administration for clearance to market the Atherectomy Catheter II as a treatment for severely calcified coronary arteries. In addition, the Atherectomy Catheter II includes a vacuum mechanism that extracts any removed plaque from the arteries and from the patient. According to estimates by the American Heart Association, as many as 8 to 12 million Americans have PAD. In addition, a study by The SAGE Group, based on …

National Institutes of Health

Three decades before coronavirus, Anthony Fauci took heat from AIDS protesters | 5/20/2020

… Back, Fight AIDS!” The angry chanting grew louder as hundreds of protesters wove through the usually placid campus of the National Institutes of Health in Bethesda on May 21, 1990. With signs that read, “Red … and homophobia flourished, ACT UP staged theatrical protests at the Food and Drug Administration, on Wall Street and at New York’s City Hall. The most famous was a 1989 die-in at New York’s St …

Digital Health

Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind | 5/18/2020

AUSTIN, Texas , May 18, 2020 /PRNewswire/ – Everlywell , the digital health company which offers individuals access to at-home collection lab tests for cholesterol, diabetes, STIs, hormones, and more, today announced that the company has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 at-home collection kit. Everlywell’s EUA is the first to be issued to a digital health company such …

Oncology

ENHERTU Granted Breakthrough Therapy Designation in the US for HER2-Mutant Metastatic Non-Small Cell Lung Cancer | Business & Finance | manchestertimes.com | 5/18/2020

… Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines. José Baselga, Executive Vice President, R&D Oncology, said: “Today’s news is very …

Medicaid

‘We need a comprehensive battle strategy’: States opening their economies lack benchmarks for reimposing restrictions - The Washington Post | 5/15/2020

Food and Drug Administration and administrator of the Centers for Medicare and Medicaid Services under President George W. Bush, said state leaders know “they may need to pause or even step back.” AD Sign up for our Coronavirus Updates newsletter to track the outbreak. All stories linked in the newsletter are free to access. “But we haven’t seen a whole lot of detail on those specific plans in most states …

Medicare

‘We need a comprehensive battle strategy’: States opening their economies lack benchmarks for reimposing restrictions - The Washington Post | 5/15/2020

Food and Drug Administration and administrator of the Centers for Medicare and Medicaid Services under President George W. Bush, said state leaders know “they may need to pause or even step back.” AD Sign up for our Coronavirus Updates newsletter to track the outbreak. All stories linked in the newsletter are free to access. “But we haven’t seen a whole lot of detail on those specific plans in most states …

Centers for Medicare and Medicaid Services

‘We need a comprehensive battle strategy’: States opening their economies lack benchmarks for reimposing restrictions - The Washington Post | 5/15/2020

Food and Drug Administration and administrator of the Centers for Medicare and Medicaid Services under President George W. Bush, said state leaders know “they may need to pause or even step back.” AD Sign up for our Coronavirus Updates newsletter to track the outbreak. All stories linked in the newsletter are free to access. “But we haven’t seen a whole lot of detail on those specific plans in most states …

American Society of Clinical Oncology

Lilly Oncology Showcases Innovation in Cancer Research at ASCO 2020 | 5/14/2020

… Eli Lilly and Company’s (NYSE: LLY ) oncology product portfolio will be presented at the 56 th Annual Meeting of the American Society of Clinical Oncology (ASCO), held virtually, May 29-31, 2020 . The data, which include … selective oral RET kinase inhibitor—received approval from the U.S. Food and Drug Administration (FDA) metastatic RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic RET -mutant medullary thyroid cancer (MTC) and …

Patient Safety

QuVa Pharma® Prepared For Increased Output Of Sterile Compounding Of Essential Medicines For COVID-19 Crisis | 5/13/2020

SUGAR LAND, Texas QuVa Pharma, Inc. confirms its ability to provide essential medicines on shortage for the treatment of critically ill COVID-19 patients given the Food and Drug Administration’s (FDA) announcement of the “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency” , as well as the Drug Enforcement Agency’s (DEA) steps to increase quota on controlled substances. QuVa …

Department of Health and Human Services

Fauci warns ‘little spikes’ of coronavirus could turn into dangerous outbreaks if states open without necessary mitigation | 5/12/2020

Food and Drug Administration commissioner Stephen Hahn, and Brett Giroir, who is leading coronavirus testing at the Department of Health and Human Services, also testified. Visit Business Insider’s homepage for more stories . Dr. Anthony Fauci, the nation’s top infectious disease expert, warned in a Senate hearing on Tuesday that the country will see potentially devastating resurgences of the coronavirus if states and localities relax social distancing without heeding federal guidelines …

Kaiser Family Foundation

News Brief: Senate Hearing, Supreme Court, Nursing Homes : NPR | 5/12/2020

… two months ago. Fauci’s going to be joined alongside the heads of the Centers for Disease Control and Prevention, the Food and Drug Administration and the U.S. Public Health Service. And the hearing is essentially … said, the data’s incomplete. But it’s also pretty alarming. There’s Kaiser Family Foundation data that shows nursing home deaths now account for more than half of all COVID-19 deaths. That’s just in 14 states …

American Diabetes Association

Oramed Pharmaceuticals to Present at the 80th American Diabetes Association Scientific Session, to be Held Virtually This Year in June | 5/5/2020

… pharmaceutical company focused on the development of oral drug delivery systems, today announced it will present during the 80 th American Diabetes Association Scientific Sessions, held virtually this year June 12-16, 2020 . Oramed’s Chief Scientific … trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901 . For more information, please …

National Cancer Institute

Liquid Biopsy Industry Outlook 2020-2030 by Product, End-user, Clinical Application, Region, Country | 5/5/2020

… market Government funds helps researchers in drug discovery, diagnosis, and treatment of diseases such as Cancer. For instance, in 2019, National Cancer Institute (NCI), a USA -based government agency gave funds worth $2.1 million and … used in a single laboratory. For instance, in 2019, the Food and Drug Administration (FDA) proposed a plan to increase the regulations for the approval of laboratory developed tests. However, the regulations are unclear and …

Patient Satisfaction

Galderma Receives FDA Approval For Restylane® Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed And Indicated To Add Fullness To The Lips And Help Smooth The Wrinkles Above The Mouth | PR Newswire | 5/5/2020

FORT WORTH, Texas , May 5, Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane ® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles around upper lips) in adults … for up to 1 year 1,2 with high levels of patient satisfaction for people with lips that have changed due to the aging process or for those seeking natural-looking, fuller lips. 3 Experience the …

AACR

Clinigen: IL-2 Plays Role in Emerging TIL Therapies | Business Wire | 5/4/2020

… the Thoracic Oncology, Immunology Program of the Moffitt Cancer and Research Institute presented at the American Association for Cancer Research (AACR) virtual annual meeting on April 28, 2020. Eligibility criteria described in trial registry (NCT03215810 … cell carcinoma (mRCC) or metastatic melanoma (mM) by the US Food and Drug Administration (FDA). For further information, specific to the US product dosing and administration please visit www.proleukin.com . IL-2 is being studied in …

American Association for Cancer Research

Clinigen: IL-2 Plays Role in Emerging TIL Therapies | Business Wire | 5/4/2020

… C. Creelan MD, MS from the Thoracic Oncology, Immunology Program of the Moffitt Cancer and Research Institute presented at the American Association for Cancer Research (AACR) virtual annual meeting on April 28, 2020. Eligibility criteria … cell carcinoma (mRCC) or metastatic melanoma (mM) by the US Food and Drug Administration (FDA). For further information, specific to the US product dosing and administration please visit www.proleukin.com . IL-2 is being studied in …

Big Pharma

Five myths about vaccines | 5/2/2020

… community often claims that vaccines are incredibly lucrative. In 2019, anti-vaccination activist Del Bigtree released a video titled “Vaccines: Big Pharma’s Cash Cow” full of ominous music that pointed out how vaccine profits increased … Washington University in St. Louis revealed that by 2000, the Food and Drug Administration had approved vaccines to shield Americans from 26 different pathogens (two target the same virus and one was withdrawn). Two decades …

Clinical Data

Concert Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Update on Clinical Programs | Business Wire | 4/30/2020

… and Upcoming Milestones CTP-543: An Investigational Treatment for Moderate-to-Severe Alopecia Areata CTP-543 Poised to Advance into Phase 3 Testing. Following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in March 2020, the Company plans to initiate its Phase 3 program of CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete …

Digital Therapeutics

Pear releases schizophrenia therapeutic after FDA loosens digital health regulations during pandemic - MedCity News | 4/30/2020

After the Food and Drug Administration temporarily waived restrictions around software tools for mental health , a handful of digital health companies have already released new solutions to the public. Pear Therapeutics, which already has three FDA-cleared digital therapeutics under its belt, plans to make a product candidate for schizophrenia available on a limited basis. Called Pear-004, the digital therapeutic is not yet FDA approved. It is intended to …

Regenerative Medicine

BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update | Globe Newswire | 4/29/2020

Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC …

Biotech

Leading Biotech Companies Kedrion Biopharma of Italy and Kamada Ltd. of Israel Announce Global Collaboration to Speed New Anti-COVID Plasma-Based Treatment | PR Newswire | 4/29/2020

… donors in both Europe and the U.S. who have recovered from the virus. KEDPLASMA USA , with the approval of the Food and Drug Administration (FDA), has already begun collecting COVID-19 convalescent plasma in three … quite rapidly. The new partnership between the Italian and Israeli biotech companies could therefore become one of the first that is able to make this product available to patients in need. Alessandro Gringeri, Chief Medical …

CAR-T

Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia | PR Newswire | 4/29/2020

… T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation … expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies …

Medical Research

VistaGen Expands PH94B Clinical Development to Include Adjustment Disorder Related to COVID-19 | 4/28/2020

… to submit its proposed protocol for a Phase 2 study of PH94B for treatment of adjustment disorder to the U.S. Food and Drug Administration (FDA) through the FDA’s new Coronavirus Treatment Acceleration Program (CTAP). The … Professor of Clinical Psychiatry at Columbia University and directs the Medical Research Network LLC in New York City . He directed the Anxiety Disorders Clinic at the New York State Psychiatric Institute from 1982 to 2006 …

University of Utah

With Antibody Testing Now Available, ARUP Provides Testing Nationwide to Help Diagnose, Monitor, and Treat COVID-19 | 4/28/2020

… identified 55 percent of COVID-19-positive individuals in the state. The laboratory, which is a nonprofit enterprise of the University of Utah , has the capacity to perform up to 4,500 diagnostic tests per day … Medicine. ARUP’s laboratory scientists already had experience with the U.S. Food and Drug Administration’s Emergency Use Authorization process required for the development of COVID-19 tests because they followed the process to develop tests for …

Thermo Fisher

Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection | 5/20/2020

Thermo Fisher Scientific Inc.’s TaqPath™ RT-PCR COVID-19 Kit, which received Emergency Use Authorization (EUA) on March 13, 2020 from the U.S. Food and Drug Administration. To access information on Pathnostics’ new COVID-19 PCR test, visit https://www.pathnostics.com/covid-19-pcr-test/ . Pathnostics’ new PCR test is administered using a simple nasal swab that can detect the genetic information of the virus within 24 to 48 hours …

Cardinal Health

Quidel’s Lyra® Direct SARS-CoV-2 Assay Receives Emergency Use Authorization and CE Mark for Molecular Detection of COVID-19, Without Extraction Step | Markets Insider | 5/19/2020

… announced today that Quidel has received Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing. Lyra® Direct Removes RNA Extraction … purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative. Applied Biosystems®, CFX96 Touch®, Rotor-Gene Q®, LightCycler® 480, Cobas z480, and QuantStudio 7 Pro® are registered trademarks of their respective owners …

Abbott Laboratories

Abbott pushes back on study of coronavirus-test accuracy, false negatives - Business Insider | 5/19/2020

… Food and Drug Administration. Abbott has major issues with the way the NYU researchers evaluated the machine. One executive called the study “not good science.” Visit Business Insider’s homepage for more stories . The healthcare giant Abbott Laboratories is pushing back on a study that said its rapid coronavirus test is about as accurate as a coin toss. Abbott said its machine, called the ID Now COVID-19, is very reliable …

EverlyWell

Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind | 5/18/2020

AUSTIN, Texas , May 18, 2020 /PRNewswire/ – Everlywell , the digital health company which offers individuals access to at-home collection lab tests for cholesterol, diabetes, STIs, hormones, and more, today announced that the company has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 at-home collection kit. Everlywell’s EUA is the first to be issued to a digital health company such …

Apple Health

Americans are moving again — see how driving, walking and transit are returning to normal | 5/15/2020

… directions again. After two months of social distancing and staying home to curb the spread of the coronavirus, data from Apple suggests that people in several cities, most of them where reopening plans are in … used by White House — could be inaccurate, FDA warns The Food and Drug Administration issued an alert Thursday warning that a common COVID-19 diagnostic test could be giving inaccurate results. President Donald Trump recently …

Sarah Cannon Research Institute

TCR² Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update | 5/14/2020

… 2020 Continued progress of TC-110 with initiation of leading clinical sites participating in Phase 1/2 clinical trial that include Sarah Cannon Research Institute and Colorado Blood Cancer Institute TC-110 granted orphan drug designation … very near future,” added Dr. Menzel. Recent Developments The U.S. Food and Drug Administration granted orphan drug designation to TC-110 for the treatment of acute lymphoblastic leukemia. TCR 2 nominated a CD70 targeted TRuC …

Bristol-Myers Squibb

Bristol-Myers to Resubmit Myeloma-Drug Bid to FDA - Here’s the Trade - TheStreet | 5/13/2020

Buy Bristol-Myers on weakness to its weekly value level at $60.75 and reduce holdings on strength to its monthly risky level at $69.39. Author: Richard Suttmeier Publish date: May 13, 2020 1:15 PM EDT Bristol-Myers Squibb ( BMY ) - Get Report and Bluebird Bio ( BLUE ) - Get Report in a couple of months will resubmit their bid for an experimental multiple-myeloma treatment to the U.S. Food and Drug Administration for …

Bristol-Myers

Bristol-Myers to Resubmit Myeloma-Drug Bid to FDA - Here’s the Trade - TheStreet | 5/13/2020

Buy Bristol-Myers on weakness to its weekly value level at $60.75 and reduce holdings on strength to its monthly risky level at $69.39. Author: Richard Suttmeier Publish date: May 13, 2020 1:15 PM EDT Bristol-Myers Squibb ( BMY ) - Get Report and Bluebird Bio ( BLUE ) - Get Report in a couple of months will resubmit their bid for an experimental multiple-myeloma treatment to the U.S. Food and Drug Administration for …

Pfizer

Investors just poured $14.6 billion into startups working to transform healthcare. These are the 10 companies that pulled in the most cash. | 5/12/2020

… subsidiary Janssen on a cell therapy for multiple myeloma. The treatment recently won an expedited approval process from the US Food and Drug Administration, according to the companies . Concerto HealthAI - $150 million Concerto employees are … into other therapy areas. Concerto announced the deal, partnerships with Pfizer and Janssen, and a new research platform at the J.P. Morgan Morgan Healthcare Conference in January. Called eurekaHealth 3.0, the platform combines data from …

Gilead Sciences

AHF Demands Gilead Price Remdesivir at $1.00 per Dose | 5/12/2020

Gilead Sciences also disclose all its public research and development costs and all public investments in connection with the development of remdesivir. AHF’s dollar per dose demand is based on a University of Liverpool research study , “ Minimum costs to manufacture new treatments for COVID-19” that allows for recovery of the cost of manufacturing plus a reasonable profit. On May 1 st , the U.S. Food and Drug Administration (FDA) approved …

Teva Pharmaceutical

Eagle Pharmaceuticals Reports First Quarter 2020 Results | 5/11/2020

… fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer, met internal objectives, and requested additional meeting with U.S. Food and Drug Administration (“FDA”) to discuss regulatory path forward; Submitted Investigational New Drug (“IND … District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed ANDA products. Defendants will be enjoined …

Merck

Electronic Skin Patches Market, Forecast to 2025 with a COVID-19 Pandemic Impact Assessment | 5/7/2020

food and drug administration (FDA), in the USA , and increased funding from government and other related organizations. Major players in the Global Electronic Skin Patches Market include Quad Industries, Medtronic, MC10, Vitalconnect, Blue Spark Technologies, VivaLNK, Loreal, Proteus Digital Health, Nemaura Medical, Cardiomo, Life Signal, Lief Therapeutics, Isansys Lifecare, Xsensio, Rotex, GE Healthcare, Merck, Boston Scientific, 3M , Daiichi Sankyo, etc. Years considered for this report: Historical Years: 2015-2018 Base Year …

Medtronic

Electronic Skin Patches Market, Forecast to 2025 with a COVID-19 Pandemic Impact Assessment | 5/7/2020

food and drug administration (FDA), in the USA , and increased funding from government and other related organizations. Major players in the Global Electronic Skin Patches Market include Quad Industries, Medtronic, MC10, Vitalconnect, Blue Spark Technologies, VivaLNK, Loreal, Proteus Digital Health, Nemaura Medical, Cardiomo, Life Signal, Lief Therapeutics, Isansys Lifecare, Xsensio, Rotex, GE Healthcare, Merck, Boston Scientific, 3M , Daiichi Sankyo, etc. Years considered for this report: Historical Years: 2015-2018 Base Year …

Boston Scientific

Electronic Skin Patches Market, Forecast to 2025 with a COVID-19 Pandemic Impact Assessment | 5/7/2020

food and drug administration (FDA), in the USA , and increased funding from government and other related organizations. Major players in the Global Electronic Skin Patches Market include Quad Industries, Medtronic, MC10, Vitalconnect, Blue Spark Technologies, VivaLNK, Loreal, Proteus Digital Health, Nemaura Medical, Cardiomo, Life Signal, Lief Therapeutics, Isansys Lifecare, Xsensio, Rotex, GE Healthcare, Merck, Boston Scientific, 3M , Daiichi Sankyo, etc. Years considered for this report: Historical Years: 2015-2018 Base Year …

Novartis

Akcea Reports Financial Results and Highlights for First Quarter 2020 | 5/5/2020

… countries, and potential to file for approval in Brazil through PTC Therapeutics Refile WAYLIVRA ® (volanesorsen) in the U.S. with the Food and Drug Administration, or FDA, this year Initiate a Phase 3 study of AKCEA … in the first quarter of 2019 as a result of Novartis’ exercise of its option to license AKCEA-APO(a)-L Rx . Expenses Akcea’s operating expenses, net of the reimbursement due from Ionis through the …

CVS

Hand Sanitizer Market Size to Hit USD 1.96 Billion by 2026; Steadily Rising Awareness About Hygiene and Sanitation to Propel Industry Growth, Says Fortune Business Insights™ | PR Newswire | 5/5/2020

… Profiled are SC Johnson & Son, Inc., Best Sanitizer Inc., Bacardi Limited, Himalaya Global Holdings Ltd., Gojo Industry Inc., Proctor & Gamble, CVS Health, Unilever Plc., Henkel AG & Company, Reckitt Benckiser, among others News provided by May … Analysis, Insights and Forecast, 2015-2026 In addition to this, the Food and Drug Administration (FDA) has found that alcohol-based sanitizers can fight the spread of flu-like infections due to their superior germ-killing …

CVS Health

Hand Sanitizer Market Size to Hit USD 1.96 Billion by 2026; Steadily Rising Awareness About Hygiene and Sanitation to Propel Industry Growth, Says Fortune Business Insights™ | PR Newswire | 5/5/2020

… Profiled are SC Johnson & Son, Inc., Best Sanitizer Inc., Bacardi Limited, Himalaya Global Holdings Ltd., Gojo Industry Inc., Proctor & Gamble, CVS Health, Unilever Plc., Henkel AG & Company, Reckitt Benckiser, among others News provided by May … Analysis, Insights and Forecast, 2015-2026 In addition to this, the Food and Drug Administration (FDA) has found that alcohol-based sanitizers can fight the spread of flu-like infections due to their superior germ-killing …

Sandoz

Hydroxychloroquine Market to Reach USD 2,339.1 Million by 2027; Driven by the Increasing Number of Covid-19 Cases, says Fortune Business Insights™ | 5/4/2020

Key Companies Covered in the Hydroxychloroquine Market Research Report are Sanofi, Zydus Cadia, Ipca Laboratories Ltd, Sandoz International GmbH, Mylan N.V., Teva Pharmaceutical Industries Ltd, Bayer AG and other key market players. May 04, 2020 … use by leading authorities such as the EU and the Food and Drug Administration for treatment of patients suffering from arthritis as well as autoimmune diseases such as lupus. The ongoing coronavirus outbreak has led …

Genentech

Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark | 5/3/2020

… widely available around the world Basel, 03 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) 1 for its … in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more …

GSK

£5k to spend? 3 FTSE 100 shares I’d buy in an ISA today | 5/2/2020

… start of May has left plenty of British blue chips looking too cheap to miss. I’d certainly buy GlaxoSmithKline (LSE: GSK) today. It’s failed to track its FTSE 100 rival AstraZeneca higher in recent weeks … treatment for patients with ovarian cancer received the approval of Food and Drug Administration officials in the US to keep its proud record going. Recent successes are also why group sales rocketed 19% in the …

AbbVie

Gilead Lobbying Rose As Interest In COVID-19 Treatment Climbed | NPR | 5/2/2020

… of remdesivir, an antiviral drug that has become the most closely watched COVID-19 treatment under development. On Friday, the Food and Drug Administration authorized the emergency use of remdesivir for patients hospitalized with severe … help streamline the regulatory process for a new product. Gilead, AbbVie and Regneron are among the pharmaceutical companies that spent more on lobbying in the first quarter than they ever had in previous quarters, according …

GlaxoSmithKline

£5k to spend? 3 FTSE 100 shares I’d buy in an ISA today | Yahoo News | 5/2/2020

… at the start of May has left plenty of British blue chips looking too cheap to miss. I’d certainly buy GlaxoSmithKline (LSE: GSK) today. It’s failed to track its FTSE 100 rival AstraZeneca higher in … treatment for patients with ovarian cancer received the approval of Food and Drug Administration officials in the US to keep its proud record going. Recent successes are also why group sales rocketed 19% in the …

Celgene

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia | Business Wire | 5/1/2020

PRINCETON, N.J.–(BUSINESS WIRE)–May 1, 2020– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral … or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram . Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and …

Medline

After meeting with Trump, Medline wants FDA approval to sterilize N95 masks with ethylene oxide. Two other federal agencies are against it, citing cancer risks for health care workers. | Chicago Tribune | 4/29/2020

Medline executives remain undeterred. The privately held company is lobbying the Food and Drug Administration for emergency authority to sterilize N95 masks. The masks capture 95% of air particles when properly fitted, effectively shielding workers from the virus. An approved alternative Hospitals throughout the country are scrambling to adopt methods that can deactivate the virus in protective equipment. One alternative to ethylene oxide already is up and running at another …

Vizient

Hospital demand for hydroxycholoroquine to treat Covid-19 patients is waning | 4/28/2020

… Vizient, a group purchasing organization that negotiates contracts for medicines on behalf of about 3,000 hospitals and health care facilities in the U.S. At the same time, supplies appear to be stabilizing, most likely due to donations from several large manufacturers — including Bayer, Teva Pharmaceutical and Novartis — that agreed to provide millions of tablets to the U.S. Strategic National Stockpile after the Food and Drug Administration issued an emergency use …

New Enterprise Associates

NEA-backed Personal Genome Diagnostics receives FDA clearance for its cancer diagnostic | TechCrunch | 4/28/2020

… of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test. The test’s approval is … over $99 million, according to Crunchbase . The company’s investors include New Enterprise Associates, Bristol Myers Squibb, Inova Strategic Investments, Co-win Healthcare Fund, Helsinn Investment Fund, Windham Venture Partners, Maryland Venture Fund “We are proud …

HealthCare Royalty Partners

Chiasma Enters Into Revenue Interest Financing Agreement for up to $75 Million with Healthcare Royalty Partners | Globe Newswire | 4/8/2020

HealthCare Royalty Partners (HCR) for up to $75 million to support the ongoing development and planned commercial launch of its investigational octreotide capsules product candidate, trade-named MYCAPSSA ® , for the maintenance treatment of adults with acromegaly. Under the terms of the agreement, Chiasma will receive $25 million from HCR on April 14, 2020 and is entitled to receive an additional $25 million upon the U.S. Food and Drug Administration (FDA …

Goldman Sachs

Immunomedics Gets Double-Downgrade to Sell From Goldman Sachs - TheStreet | 4/3/2020

Immunomedics receives a double downgrade to sell from buy at Goldman Sachs. Author: Rob Lenihan Publish date: Apr 3, 2020 11:30 AM EDT Immunomedics ( IMMU ) - Get Report received a double downgrade to sell from buy from an analyst at Goldman Sachs, who cited a report by the Food and Drug Administration that found new quality control issues at the biopharm company's manufacturing site. Shares of the Morris Plains …

Gurnet Point Capital

Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL® for the Management of Postsurgical Pain after Open Inguinal Hernia Surgery | PR Newswire | 3/26/2020

PRNewswire/ – Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for XARACOLL ® (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for the management of postsurgical pain after open inguinal hernia surgery. The FDA set a PDUFA goal date of August 26, 2020 . “The FDA acceptance of the …

Bill & Melinda Gates Foundation

Study behind updated FDA guidance shows self-swab tests are as effective as those done by clinicians | TechCrunch | 3/25/2020

Earlier this week, the U.S. Food and Drug Administration (FDA) announced that it would be updating its guidance to allow self-swab tests for COVID-19 , in which a patient collects a sample from their … deeper inside a person’s nasal cavity. UnitedHeatlh worked with the Bill & Melinda Gates Foundation, as well as Quest Diagnostics and the University of Washington to conduct the study, which covered almost 500 patients who received …

Morgan Stanley

Covid-19 clinical trials expedited as trials in other diseases put on hold, Northwell exec says - MedCity News | 3/22/2020

Getting a clinical trial up and running is no simple task. Writing the protocol, securing Food and Drug Administration and institutional review board approvals, site activations and product manufacturing can take months. So it may … amid the viral pandemic. In a note to investors Thursday, Morgan Stanley analyst David Risinger wrote that major academic centers in Covid-19 cluster areas are increasingly preparing for a surge in patients with the …

Alger

Three stocks that are ‘part of the solution’ to the coronavirus crisis - MarketWatch | 3/20/2020

Amy Zhang of Fred Alger Management owns three innovative companies in her funds that she expects to be “part of the solution” to the coronavirus crisis, as they help with diagnostic testing, mass notification and … March 17, the company received emergency use authorization from the Food and Drug Administration for its Lyra SARS-CoV-2 Assay — a testing kit “for the qualitative detection of nucleic acid from SARS-CoV-2 …

Fred Alger Management

Three stocks that are ‘part of the solution’ to the coronavirus crisis - MarketWatch | 3/20/2020

Amy Zhang of Fred Alger Management owns three innovative companies in her funds that she expects to be “part of the solution” to the coronavirus crisis, as they help with diagnostic testing, mass notification and … March 17, the company received emergency use authorization from the Food and Drug Administration for its Lyra SARS-CoV-2 Assay — a testing kit “for the qualitative detection of nucleic acid from SARS-CoV-2 …

Khosla Ventures

E25Bio Closes Financing from Khosla Ventures to Rapidly Diagnose Coronavirus | Business Wire | 3/18/2020

… Khosla Ventures. Founded in 2018 and based out of The Engine at MIT, the company develops technology for rapid diagnosis of dangerous infectious diseases such as dengue, zika, and now the novel coronavirus. As the coronavirus (SARS-CoV-2) pandemic continues to grow globally, effective, early and accessible testing has come into focus. The U.S. Food and Drug Administration’s announcement of fast tracking diagnostics for the virus through its Emergency …

Canopy Growth

Global Medical Marijuana Market Sees An Increase in Clinical Trials | PR Newswire | 2/14/2020

… cultivators and producers are the most critical piece of the cannabis ecosystem, revenue comes significantly from pharmaceutical organizations. The U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as medicine … 12+ companies working in this domain, such as GW Pharmaceuticals, Canopy Growth Corporation, Aurora Cannabis, Auxly Cannabis Group and others. GW Pharmaceuticals has two medical marijuana products in the market; Epidiolex and Sativex. Epidiolex (cannabidiol …

Merrill Lynch

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Adamas Pharmaceuticals, Cintas, Correvio Pharma, and Exelon and Encourages Investors to Contact the Firm | Globe Newswire | 1/9/2020

… 10, 2020 Adamas’s primary product is GOCOVRI, an extended-release formulation of amantadine, which has been approved by the U.S. Food and Drug Administration for the treatment of levodopa-induced dyskinesia. On March 4, 2019 … March 5, 2019. On September 30, 2019, Bank of America/Merrill Lynch analyst Tazeen Ahmad lowered its rating for Adamas shares to “Underperform” noting “existing overhangs for ADMS: (1) GOCOVRI coverage: a number of national …

NCI

Strides in lung cancer lead steep decline in U.S. cancer deaths | Yahoo News | 1/8/2020

NCI after a stint as acting commissioner of the Food and Drug Administration, believes some of the gains in lung cancer are related to better therapies, but given that the report only goes through 2017, many of the new drugs for lung cancer, such as Merck’s Keytruda, have yet to be reflected in the mortality data. “We think the lung cancer data are going to continue to improve for a …

Oxford Finance

Regulus Therapeutics Announces FDA Removal of Partial Clinical Hold for Multiple Ascending Dose Study of RGLS4326 | PR Newswire | 12/16/2019

… Nasdaq: RGLS ), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced the U.S. Food and Drug Administration (“FDA”) has lifted the Partial Clinical Hold on the Company’s Phase … concluding an amendment (the “Amendment”) of its term loan with Oxford Finance LLC, upon the Milestone Closing, the Company will receive an additional twelve-month period of interest-only payments extending the interest-only period …

Longitude Capital

Talaris Therapeutics to Present at American Society of Hematology (ASH) Annual Meeting | Business & Finance | manchestertimes.com | Business Wire | 12/6/2019

… or blood disorders. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant … is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA and maintains corporate offices in Boston, MA and Louisville, KY. www.TalarisTx.com . View source version on businesswire.com : https://www.businesswire.com …

RBC Capital Markets

Innovative Cellular Therapeutics Strengthens Executive Leadership Team with Appointment of Morten Marott as Chief Financial Officer | Globe Newswire | 12/5/2019

… worldwide. We are already off to a strong start in the United States with the recent clearance by the U.S. Food and Drug Administration (FDA) of our Investigational New Drug (IND) application for ICTCAR014 in … this, he was with the Healthcare Investment Banking Groups of RBC Capital Markets and Citigroup. He has more than a decade of Wall Street experience in M&A, healthcare investment banking and equity research with …

Citigroup

Innovative Cellular Therapeutics Strengthens Executive Leadership Team with Appointment of Morten Marott as Chief Financial Officer | Globe Newswire | 12/5/2019

… worldwide. We are already off to a strong start in the United States with the recent clearance by the U.S. Food and Drug Administration (FDA) of our Investigational New Drug (IND) application for ICTCAR014 in … the Healthcare Investment Banking Groups of RBC Capital Markets and Citigroup. He has more than a decade of Wall Street experience in M&A, healthcare investment banking and equity research with a primary focus on …

Sequoia Capital

Reuters Health News Summary | Yahoo News | 12/4/2019

… cancer as the Swiss drugmaker seeks to establish its alternative to drugs from Merck and Bristol-Myers Squibb. The U.S. Food and Drug Administration approved Tecentriq mixed with Celgene’s Abraxane and carboplatin chemotherapy to treat … online sellers such as Medlife, Netmeds, Temasek-backed PharmEasy and Sequoia Capital-backed 1mg has threatened traditional drug-store businesses. Powder Keg: FDA bowed to industry for decades as alarms were sounded over talc At …

DEFTA Partners

Female-led Abilitech Medical raises $7.4 million | Star Tribune | 12/4/2019

… round of investor capital; topping the $3.2 million in equity and debt it received in separate placements since January 2017. Chief Executive Angie Conley said the money will be used to obtain U.S. Food and Drug Administration clearance next year of its flagship product, support a clinical study of muscular dystrophy patients at the University of Minnesota and Gillette Children’s Hospital and to fund further commercialization and sales initiatives. Abilitech …

Andreessen Horowitz

30 companies worth at least $1 billion that didn’t exist 10 years ago | Business Insider | 12/4/2019

… more controversial startups of this decade, Juul, the e-cigarette company, sparked national outrage, congressional investigations, and criticism by the Food and Drug Administration, leading to total product bans in some countries . Juul’s rise was … around $5 billion from big-name investors like General Motors, Andreessen Horowitz, and Google’s parent company Alphabet, before eventually going public at $72 a share. Since then, its share price has traded below the IPO …

ROTH Capital Partners

Why the Medical Device Tax Should Be Repealed | 12/3/2019

… though this is a more traditional way to levy excise taxes. Taxable medical devices are listed as devices with the Food and Drug Administration (FDA) under Section 510(j) of the Federal Food, Drug, and … Dolan, “Innovation 101 – Technology & Innovation in the Medical Device Industry,” Roth Capital Partners, Sept. 13, 2012, http://www.roth.com/files/marketing/email_blasts/Roth%20Capital%20CONNECT.pdf . [17] Daeyong Lee, “Impact of the Excise Tax on Firm …

Wellington Management

Impulse Dynamics Secures $80.25 Million Financing | The Wapakoneta Daily News | 12/3/2019

… and help it beat more forcibly. Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll … Smart System was granted Breakthrough Device designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the …

SVB Leerink

The return of the megamerger | 12/2/2019

… of deal: Cholesterol-lowering drug in late-stage studies Source: Companies According to an analysis done by the investment firm SVB Leerink, global pharmaceutical merger and acquisition activity is on track to hit a 10 … will continue to build their pipelines through midsized purchases. The Food and Drug Administration’s revolving door Leadership at the US agency expected to shift from Gottlieb to Sharpless to Hahn Credit: Brendan Mcdermid/Reuters/Newscom …

Piper Jaffray

Novus Therapeutics to Participate in Two Investor Conferences | Business Wire | 11/29/2019

… of the ear, nose, and throat (ENT), today announced that the company will participate in two investor conferences in December. Piper Jaffray 31st Annual Healthcare Conference Lotte Palace Hotel, New York, NY December 3-5, 2019 … any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will …

Fidelity Investments

JUUL’s desire to impress investors led to public health crisis | 11/28/2019

When JUUL was first introduced in the United States, its manufacturer was in a race to please investors, like Fidelity Investments. Vaping was so new the product was not restricted by federal regulations. But investors … in 10 middle school students now vape, according to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) so did JUUL’s profits. JUUL quickly snapped up 75% of the …

Silicon Valley Bank

Health tech funding snapshot—Sony joins $42M round in endoscopy AI company; Wellframe raises $20M | FierceHealthcare | 11/27/2019

… AI Medical Service aims to improve endoscopic medical care through the use of AI. The company recently announced that the Food and Drug Administration (FDA) provided a breakthrough device designation for its machine learning algorithm … Insurance Company, Susquehanna International Group, Sojitz Corporation, Zuellig Pharma and Silicon Valley Bank. Sensely uses avatars and chat-based platforms to help users understand and organize their insurance information. Kidney stone medical device: SonoMotion , a …

Massachusetts General Hospital

Inhaled Nitric Oxide Explored for COVID-19 Oxygenation | 5/13/2020

… at-home use of the tankless inhaled nitric oxide system ( GENOSYL DS , VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment … in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston. The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a …

Cleveland Clinic

Doctors are unsure which Covid-19 patients should get remdesivir - STAT | 5/12/2020

… statistically prove whether or not it increased a person’s chances of surviving Covid-19. Within days of the announcement, the Food and Drug Administration issued an emergency authorization so clinicians could start treating patients with … take our best guess,” said Dan Culver, a pulmonologist at Cleveland Clinic. “Remdesivir, from what we can tell right now, looks like it may be helpful, but I think it would be a mistake to …

Harvard Medical School

bluebird bio to Present Updated Results From Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma During ASCO20 Virtual Scientific Program | Business Wire | 5/8/2020

… Nikhil C. Munshi, MD, The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA Session Title: Hematologic Malignancies- Plasma Cell Dyscrasia Date & Time … a Biologics License Application for ide-cel to the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory …

Cleveland Clinic, Cleveland OH

First Patients Dosed in Phase 2/3 Randomized Controlled Trial of Mesoblast’s Remestemcel-l for COVID-19 Acute Respiratory Distress Syndrome | 5/6/2020

Food and Drug Administration (FDA) for robust statistical analysis. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support. The trial will include up to 30 sites across North America, with patient screening and enrollment having already commenced at Baylor University Medical Center, a part of Baylor Scott & White Health; Cleveland Clinic, Duke …

Mayo Clinic

Liquid Biopsy Industry Outlook 2020-2030 by Product, End-user, Clinical Application, Region, Country | 5/5/2020

… year grant to Translational Genomics Research Institute (TGen), a genomics research institute based in U.S.A. The funding enables TGen and Mayo Clinic researchers to drive the clinical trials for liquid biopsy test for the detection … used in a single laboratory. For instance, in 2019, the Food and Drug Administration (FDA) proposed a plan to increase the regulations for the approval of laboratory developed tests. However, the regulations are unclear and …

Northwell Health

U.S. Hospitals Promise New Safety Measures to Ease Patient Fears After Coronavirus Crush | U.S. News & World Report | 5/2/2020

Northwell Health Labs, where the same test will be used on the COVID-19, the disease caused by the novel coronavirus, after being authorized to begin semi-automated testing by the US Food and Drug Administration (FDA) in Lake Success, New York, U.S., March 11, 2020. REUTERS/Shannon Stapleton/File Photo Reuters By Deena Beasley and Gabriella Borter (Reuters) - U.S. hospitals, many past the peak coronavirus crush, are relying on …

Stanford Medicine

President, provost and dean of the School of Medicine discuss COVID-19 updates | Stanford | 4/30/2020

… stage with Lloyd Minor, dean of the Stanford School of Medicine, who had been invited to discuss the work of Stanford Medicine in response to the COVID-19 pandemic. The one-hour program began with … to identify the virus and validating the methods. When the Food and Drug Administration announced emergency-use authorization, Pinsky was one of the first scientists to submit an application and the test was one of …

Stanford Health Care, Stanford CA

President, provost and dean of the School of Medicine discuss COVID-19 updates | 4/30/2020

… pathology and of infectious diseases, began developing a diagnostic test to identify the virus and validating the methods. When the Food and Drug Administration announced emergency-use authorization, Pinsky was one of the first scientists … about the dramatic increase in online video office visits at Stanford Health Care since the outbreak of the coronavirus – up to more than 3,000 a day in April, compared with about 1,000 a day in …

Massachusetts General Hospital, Boston MA

Hospitals Update Hydroxychloroquine Protocols After FDA Warning | WebMD | 4/29/2020

… your doctor is reading on Medscape.com: APRIL 28, 2020 – Across the country, hospitals are incorporating Friday’s warning from the US Food and Drug Administration (FDA) about the risks of prescribing hydroxychloroquine and chloroquine for COVID … them, said Rajesh T. Gandhi, MD, infectious diseases physician at Massachusetts General Hospital (MGH), Boston, professor of medicine at Harvard Medical School, member of the Infectious Diseases Society of America (IDSA), and chair-elect of …

Memorial Sloan Kettering

The world wants answers on Gilead’s Covid-19 drug. Experts worry next studies may increase uncertainty | STAT | 4/27/2020

… Food and Drug Administration. “The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.” “For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach …

Memorial Sloan Kettering Cancer Center

The world wants answers on Gilead’s Covid-19 drug. Experts worry next studies may increase uncertainty | STAT | 4/27/2020

… Food and Drug Administration. “The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.” “For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach …

Beth Israel Deaconess Medical Center, Boston MA

Tracking the hunt for coronavirus drugs and vaccines - POLITICO | 4/27/2020

… Food and Drug Administration. Here’s a rundown of how this process is taking shape, and the key results expected in the coming months. Treatments Remdesivir Favipiravir Tocilizumab Baricitinib Acalabrutinib Convalescent plasma Steroids Hydroxychloroquine and chloroquine Vaccines Moderna CanSino Biologics and Beijing Institute of Biotechnology Johnson & Johnson, Beth Israel Deaconess Medical Center and BARDA Pfizer and BioNTech Sanofi and GlaxoSmithKline Remdesivir Gilead’s experimental antiviral drug was developed to treat Ebola but …

HCA

HCA Healthcare Joins COVID-19 Convalescent Plasma Study | 4/24/2020

NASHVILLE, Tenn.–(BUSINESS WIRE)–Apr 24, 2020– HCA Healthcare (NYSE: HCA), one of the nation’s leading healthcare providers, today announced 172 of its affiliated hospitals are participating in a national study to test whether plasma … MERS). The current study, which is supported by the U.S. Food and Drug Administration (FDA), is being led by the Mayo Clinic. The success of the study hinges on the continued collection of plasma from …

MD Anderson Cancer Center

NANOBIOTIX Provides Updates on Clinical Development Continuity in the Context of the COVID-19 Crisis | Business Wire | 4/21/2020

… global registration trial including elderly head and neck cancer patients ineligible for cisplatin—is currently under review by the U.S. Food and Drug Administration (FDA). Once approved, the trial will launch as soon as the … previously announced pre-clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) has been delayed due to shifting congress schedules, but should be presented later in 2020. Clinical trials from the …

Hackensack Meridian

Eagle Pharmaceuticals Announces Laboratory Test Results Demonstrating In Vitro Antiviral Activity of RYANODEX® (dantrolene sodium) Against Coronavirus SARS-CoV-2 | Business & Finance | manchestertimes.com | Business Wire | 4/16/2020

… controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack … adult COVID-19 patients with confirmed SARS-CoV-2 infection. “Hackensack Meridian Health , the largest provider of patient services in New Jersey, is committed to helping address the COVID-19 pandemic. Not only are we …

Meridian Health

Eagle Pharmaceuticals Announces Laboratory Test Results Demonstrating In Vitro Antiviral Activity of RYANODEX® (dantrolene sodium) Against Coronavirus SARS-CoV-2 | Business & Finance | manchestertimes.com | Business Wire | 4/16/2020

… controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack … COVID-19 patients with confirmed SARS-CoV-2 infection. “Hackensack Meridian Health , the largest provider of patient services in New Jersey, is committed to helping address the COVID-19 pandemic. Not only are we providing …

Kaiser Permanente

A desperate scramble as COVID-19 families vie for access to plasma therapy | NBC News | 4/15/2020

… battle they’re waging on his behalf. For days, Garcia’s mother, his aunt and his girlfriend have pleaded with doctors at Kaiser Permanente Downey Medical Center to try an experimental treatment — blood plasma from people recovered … seek emergency individual use of convalescent plasma, though the federal Food and Drug Administration recently authorized these pathways for use in critically ill patients. “The doctor just said no. His hospital is not participating in …

University of Texas MD Anderson Cancer Center

U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy | Business Wire | 4/9/2020

NEW YORK–(BUSINESS WIRE)–Apr 8, 2020– Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) for the treatment … Ph.D., FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “As the first-and-only targeted regimen for people with BRAF V600E -mutant metastatic CRC who have received …

The University of Texas MD Anderson Cancer Center

U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy | Business Wire | 4/9/2020

NEW YORK–(BUSINESS WIRE)–Apr 8, 2020– Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) for the treatment … M.D., Ph.D., FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “As the first-and-only targeted regimen for people with BRAF V600E -mutant metastatic CRC who have …

Medical University of South Carolina

Experts debate whether point of care COVID-19 testing can help flatten the curve | Modern Healthcare | 4/8/2020

… tests for SARS-CoV-2, the virus that causes COVID-19, have been granted Emergency Use Authorization from the U.S. Food and Drug Administration in the past 10 days. Decentralized molecular tests are meant to … he said. Frederick Nolte, director of clinical laboratories at the Medical University of South Carolina in Charleston, said his lab went live a week ago with the Abbott high-throughput system and is now testing …

Yale New Haven Hospital

Coronavirus (COVID-19) Update: Daily Roundup | PR Newswire | 4/2/2020

PRNewswire/ – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available : In … CLIA high complexity laboratory. Under this EUA, FDA has authorized Yale New Haven Hospital’s SARS-CoV-2 PCR test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the …

MD Anderson Cancer Center, Houston TX

CNS Pharmaceuticals Announces Business Highlights and 2019 Fourth Quarter Financial Results | PR Newswire | 3/12/2020

… its planned Phase 2 clinical trial for patients with GBM.Licensed a novel DNA-binding technology from The University of Texas MD Anderson Cancer Center to expand the clinical pipeline. In January 2020, CNS entered into … in inhibiting tumor cell proliferation.Received positive feedback from the U.S. Food and Drug Administration (“FDA”) for Pre-IND (Investigational New Drug) proposal. In its December 2019 positive response to the Company’s Pre-IND request, the …

Baylor College of Medicine

Marker Therapeutics Reports Full Year 2019 Operating and Financial Results | PR Newswire | 3/12/2020

… with acute myeloid leukemia (AML) in both the adjuvant and active disease setting. Under an amended trial design, the U.S. Food and Drug Administration (FDA) has permitted the trial to move forward with the safety … with pancreatic adenocarcinoma being conducted by its partners at the Baylor College of Medicine (BCM). In this trial, the modified T cells exhibited activity against both targeted tumor-associated antigens (TAA) and non-targeted TAAs …

Northwestern Medicine

AI-Guided Ultrasound System from Caption Health Now Commercially Available in US | PR Newswire | 3/3/2020

Food and Drug Administration (FDA). The safety and effectiveness of Caption Guidance was clinically validated in a multi-center prospective pivotal trial at Northwestern Medicine and Minneapolis Heart Institute at Allina Health with registered nurses with no prior ultrasound experience. Data on its effectiveness has been presented at conferences including the American Heart Association and the American Society of Echocardiography (ASE) Scientific Sessions. Full results of this study will be …

NewYork-Presbyterian Hospital

Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma | Business Wire | 1/24/2020

CAMBRIDGE, Mass.- Epizyme, Inc . (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK™ (tazemetostat) for the treatment of adults … M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and …

UnitedHealthcare

Statement from Aaron J. Kowalski, Ph.D., President and CEO of JDRF, on the U.S. Food and Drug Administration (FDA) authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system | PR Newswire | 12/13/2019

Statement from Aaron J. Kowalski, Ph.D., President and CEO of JDRF, on the U.S. Food and Drug Administration (FDA) authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop … manage this life-threatening disease. In particular, JDRF calls upon UnitedHealthcare to lift its restrictions which limit options of insulin pumps available to its members.” About JDRF JDRF is the leading global organization funding type …

Aetna

New ‘smart pill’ maker gains FDA approval | MedCity News | 12/10/2019

… investors on its “smart pills”, a new competitor has entered the space. Florida-based startup etectRx secured approval from the Food and Drug Administration for its sensor technology on Monday. EtectRx creates tiny wireless sensors … startup. He had most recently served as vice president of Aetna’s specialty and home-delivery pharmacy business. The company filed for FDA approval in October of last year, through the agency’s 510(k) clearance. The …

Clover Health

30 companies worth at least $1 billion that didn’t exist 10 years ago | Business Insider | 12/4/2019

… more controversial startups of this decade, Juul, the e-cigarette company, sparked national outrage, congressional investigations, and criticism by the Food and Drug Administration, leading to total product bans in some countries . Juul’s rise was … is a ripe industry to disrupt, and San Francisco-based Clover Health knows it. The company, founded in 2014, is valued at $1.2 billion. Clover Health Clover Health’s incentive is to do away with paperwork …

Cigna

Alnylam Announces New and Enhanced Framework for Value-Based Agreements to Accelerate Patient and Provider Access to GIVLAARI (givosiran) | 11/21/2019

… for subcutaneous use, a first-of-its-kind RNAi therapeutic for the treatment of AHP. Approved today by the U.S. Food and Drug Administration (FDA), GIVLAARI is indicated for the treatment of adults with AHP … and where diagnosis rates are uncertain.” “Express Scripts, Accredo, and Cigna are committed to deliver simpler, more affordable, more predictable ways for patients with rare diseases to receive appropriate care and treatment,” said Steve Miller …

Health Net

Year in Review: Rheumatic Disease Research in 2019 | 11/21/2019

… This Author Susan Manzi, MD, MPH, director of the Lupus Center for Excellence in the Autoimmunity Institute at the Allegheny Health Network in Pittsburgh, who reviewed the clinical headlines, called it “the year for psoriatic … Partnership—a collaboration by the National Institutes of Health, the Food and Drug Administration, companies and nonprofit organizations—is transforming the approach to drug development, with $42.2 million dedicated to rheumatoid arthritis and systemic lupus …

Carelink

The Future of Cardiac Rhythm Management Device Technology | DAIC | 11/11/2019

Food and Drug Administration (FDA) cleared several new cardiac rhythm management technologies. In March 2019, The FDA cleared a couple of high-voltage CRM devices, Rivacor and Acticor , designed by Biotronik to treat patients with cardiac arrhythmia. With the FDA approval, Biotronik’s Rivacor and Acticor brands became the slimmest, smallest 3 Tesla (3T) MR-conditional cardiovascular devices available in the U.S. market. Medtronic’s exclusive CareLink SmartSync Device Manager also gained …

Humana

Mallinckrodt Announces Data Publication on the Treatment Effectiveness of Acthar® Gel (Repository Corticotropin Injection) for Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan Population | PR Newswire | 11/7/2019

… changes 1 , and some people with MS experience relapses while on standard disease-modifying therapies. 2 Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of acute exacerbations of MS in … June 30, 2015 was conducted using administrative claims data from Humana Inc. MS relapse was estimated based on established claims-based methodology; and was defined as an inpatient admission or hospitalization with a principal diagnosis …

Independent Health

In The Longest-Running Post-Marketing Surveillance Study Of Its Type, Data At 24 Months On FDgard®, Presented At The American College Of Gastroenterology (ACG) Annual Meeting, Confirms Excellent Safety And Tolerability Profile Of This Nonprescription Product For Functional Dyspepsia (Meal-Triggered, Recurring Indigestion[i]) | PR Newswire | 10/29/2019

… serious and serious) for FDgard over a 24-month period from July 8, 2016 to July 8, 2018 . An independent call center staffed with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events, was retained to receive and record FDgard customer questions, product issues, and adverse events. Increasing Evidence of the Safety and Efficacy of FDgard ® FDREST …

Harvard Pilgrim Health Care

Harvard Pilgrim Health Care Institute funded up to $220 million for FDA Sentinel System | 10/9/2019

Harvard Pilgrim Health Care Institute funded up to $220 million for FDA Sentinel System Harvard Pilgrim Health Care Institute Print E-Mail BOSTON – The U.S. Food and Drug Administration has awarded a contract that may reach $220 million over the next five years to the Harvard Pilgrim Health Care Institute to continue to lead the Sentinel Operations Center and to develop a new Sentinel Innovation Center. This contract builds on …

Indian Health Service

First Edition: October 8, 2019 | Kaiser Health News | 10/8/2019

… industrial park in a northern Cincinnati neighborhood. The Forensic Chemistry Center in Cincinnati operates under the authority of the U.S. Food and Drug Administration. As a result, it’s a secretive place, and FDA officials declined … Christensen — the chief medical officer on the Navajo Nation for Indian Health Service, a partner in the research — said 781 women were screened during an initial phase of the study that ended last year. (10/7 …

Anthem

Health insurer Anthem eases restrictions on Sarepta’s Duchenne treatment | Reuters | 11/9/2017

NEW YORK (Reuters) - Health insurer Anthem Inc has eased access to Sarepta Therapeutics’ treatment for Duchenne muscular dystrophy, and on Thursday changed its reimbursement policy on its website to “medically necessary.” FILE PHOTO: The office … use before it would consider covering the costs. The U.S. Food and Drug Administration approved Sarepta for Duchenne, a degenerative disease that mostly affects young boys, last year despite questions from experts and its own …

Donald Trump

Commentary: President Trump, hydroxychloroquine and the problem with ‘snake oil’ | 5/21/2020

… Trump, hydroxychloroquine and the problem with ‘snake oil’ By Cal Thomas Tribune Content Agency May 20, 2020 4:23 PM President Donald Trump speaks with reporters after meeting with Senate Republicans at their weekly luncheon on … I get a lot of positive calls about it.” The Food and Drug Administration, according to the Washington Times, has warned against using hydroxychloroquine “outside of the hospital setting or a clinical trial due to …

Rand Paul

Three decades before coronavirus, Anthony Fauci took heat from AIDS protesters | 5/20/2020

… the coronavirus pandemic , was in favor of the group’s participation. AD Liz Cheney defends Fauci as Fox News hosts and Rand Paul attack him “I was trying to get them into all the planning meetings … and homophobia flourished, ACT UP staged theatrical protests at the Food and Drug Administration, on Wall Street and at New York’s City Hall. The most famous was a 1989 die-in at New York’s St …

Jared Kushner

Colbert on Trump taking unproven Covid-19 drug: ‘A personal best in being the worst’ | 5/20/2020

… shocking distraction tactic: his claim to reporters on Monday that he’s taking the anti-malarial drug hydroxychloroquine – a drug the Food and Drug Administration (FDA) has specifically advised not to take for coronavirus as it … of those South Korean soccer dolls,” said Noah, referring to Jared Kushner. “We’ll never know. “So Trump is either taking a dangerous, ineffective drug or he’s lying about doing it just for the LOLs,” Noah …

Mark McClellan

‘We need a comprehensive battle strategy’: States opening their economies lack benchmarks for reimposing restrictions - The Washington Post | 5/15/2020

… Mark McClellan, a former commissioner of the Food and Drug Administration and administrator of the Centers for Medicare and Medicaid Services under President George W. Bush, said state leaders know “they may need to pause or even step back.” AD Sign up for our Coronavirus Updates newsletter to track the outbreak. All stories linked in the newsletter are free to access. “But we haven’t seen a whole lot of detail …

Scott Gottlieb

Large workplaces vulnerable to coronavirus super-spread as economy reopens, experts warn | 5/14/2020

Food and Drug Administration talked about getting back to work “differently” in the face of an infection that could be with us for the long haul. Advertisement Dr. Scott Gottlieb , commissioner of the FDA from 2017 to 2019, said, “People rightly want to know when this is going to be over. And the answer is: It might not be over for a very long time until we’re able to more …

Patty Murray

Fauci warns ‘little spikes’ of coronavirus could turn into dangerous outbreaks if states open without necessary mitigation | 5/12/2020

… Patty Murray, the top Democrat on the panel, repeatedly criticized the Trump administration’s coronavirus response and urged the hearing witnesses to tell the truth. Dr. Robert Redfield, head of the Centers for Disease Control and Prevention, Food and Drug Administration commissioner Stephen Hahn, and Brett Giroir, who is leading coronavirus testing at the Department of Health and Human Services, also testified. Visit Business Insider’s homepage for more stories . Dr. Anthony …

Stephen Hahn

Report: Fauci To Tell Senate ‘Needless Suffering And Death’ Will Result From Reopening Too Quickly | 5/12/2020

Food and Drug Administration commissioner Stephen Hahn and assistant Health Secretary Adm. Brett P. Giroir. Fauci told a New York Times reporter over email that he planned to convey the warning during his testimony, and emphasized benchmarks in the Trump administration’s reopening guidelines. Fauci’s warning appears to contradict President Trump’s outlook on the virus, after Trump said “we have met the moment and we have prevailed,” in a Monday press …

Andy Slavitt

How Is The Federal Government Doing At Guiding A Smart Reopening? : NPR | 5/11/2020

NPR’s Steve Inskeep talks to Dr. Scott Gottlieb, former head of the Food and Drug Administration, and Andy Slavitt, who led the Centers for Medicare and Medicaid Services, about reopening the country. STEVE INSKEEP, HOST: Like it or not, the U.S. economy is shaking out of its many weeks on pause. Several states have lifted stay-at-home orders. Factories are reopening from Michigan to Washington state. Cellphone data show …

William Schaffner

Yet another study shows hydroxychloroquine doesn’t work against Covid-19 - CNN | 5/11/2020

Food and Drug Administration and the National Institutes of Health issued warnings about using the drugs for coronavirus patients. “The nail has virtually been put in the coffin of hydroxychloroquine,” said Dr. William Schaffner, an infectious disease expert and longtime adviser to the US Centers for Disease Control and Prevention. New York researcher says preliminary results of hydroxychloroquine study are ready, but state hasn’t released them In the most recent …

Richard Pazdur

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion | Markets Insider | 5/8/2020

SILVER SPRING, Md. , May 8, 2020 /PRNewswire/ – Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types … and offer options to patients who previously had few,” said Richard Pazdur , M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for …

Andrew Harnik

Gilead Lobbying Rose As Interest In COVID-19 Treatment Climbed | NPR | 5/2/2020

… O’Day speaks at a meeting with President Trump and members of the White House coronavirus task force on March 2. Andrew Harnik/AP hide caption toggle caption Andrew Harnik/AP Gilead Sciences CEO Daniel O’Day … closely watched COVID-19 treatment under development. On Friday, the Food and Drug Administration authorized the emergency use of remdesivir for patients hospitalized with severe cases of COVID-19. The move would make it easier …

Janet Wood

FDA grants remdesivir emergency use authorization for COVID-19 | 5/1/2020

The drug is not a cure, but has been shown to help the sickest COVID-19 patients.The Food and Drug Administration has granted remdesivir emergency use authorization to treat the most severely ill COVID-19 … use authorization is not the same as FDA approval, Dr. Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research tweeted Friday. “We need final data from clinical trials included in an …

Tim Cook

With new coronavirus tracker, Apple and Google may finally get their big break in healthcare - CNN | 4/30/2020

CNN) For years, Apple and Google have dreamed of breaking into the enormous market for personal health. Apple CEO Tim Cook has said he wants health tech to be considered Apple’s “greatest contribution” to humanity, and sought clearance from the Food and Drug Administration so that the latest Apple Watches can monitor your heart rhythm . Google has poured hundreds of millions into research on aging, cancer and neuroscience. Both have …

Chan Zuckerberg

President, provost and dean of the School of Medicine discuss COVID-19 updates | 4/30/2020

… pathology and of infectious diseases, began developing a diagnostic test to identify the virus and validating the methods. When the Food and Drug Administration announced emergency-use authorization, Pinsky was one of the first scientists … between Stanford, the University of California, San Francisco, and the Chan Zuckerberg Biohub aims to better understand the spread of COVID-19 across the Bay Area. The Chan Zuckerberg Initiative has committed $13.6 million to …

Darrell Etherington

FDA-cleared AI-based medical triage tool goes free to help busy radiology diagnostics departments | 4/30/2020

Darrell Etherington @etherington / 15 hours Medical startup Nines , which has developed an AI-based triage tool that has received clearance from the U.S. Food and Drug Administration (FDA), is making that tool available for free to all until June 30 to help address the growing burden on radiology diagnostics departments as COVID-19 continues to reshape the healthcare landscape in the U.S. NinesAI is designed to identify possible emergent cases …

Mitch McConnell

Bipartisan group pitches the White House on a $46.5 billion Covid-19 plan - STAT | 4/29/2020

… America. The political backgrounds of Kushner’s callers diverged sharply: They ranged from Scott Gottlieb, a Trump appointee who ran the Food and Drug Administration until last year, to a pair of Obama-era health officials … request for comment, and a spokesman for Senate Majority Leader Mitch McConnell referred questions to a committee aide. Support STAT: If you value our coronavirus coverage, please consider making a one-time contribution to support …

Nancy Pelosi

Bipartisan group pitches the White House on a $46.5 billion Covid-19 plan - STAT | 4/29/2020

… America. The political backgrounds of Kushner’s callers diverged sharply: They ranged from Scott Gottlieb, a Trump appointee who ran the Food and Drug Administration until last year, to a pair of Obama-era health officials … of Congress on the plan, a spokesman for House Speaker Nancy Pelosi did not respond to STAT’s request for comment, and a spokesman for Senate Majority Leader Mitch McConnell referred questions to a committee aide …

Michael Felberbaum

Gilead Sciences announces ‘positive data’ from a study on possible Covid-19 treatment remdesivir - CNN | 4/29/2020

… for coronavirus Wednesday – evidence that the experimental drug remdesivir might help patients recover more quickly from the infection. The US Food and Drug Administration has not yet approved any drugs for the treatment of the … to patients as quickly as possible, as appropriate,” FDA spokesman Michael Felberbaum said in statement. The Race for a Vaccine: Dr. Sanjay Gupta’s coronavirus podcast for April 29 The government-funded study found that patients …

Steve MacMillan

Hologic Announces Financial Results for Second Quarter of Fiscal 2020 | 4/29/2020

… years, and give us confidence that we will emerge from the current COVID-19 pandemic as a stronger company,” said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer. “We performed very well through most … assay, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The Company has successfully scaled up manufacturing and is now producing nearly 600,000 Panther Fusion SARS-CoV-2 tests a month …

Jonathan Shieber

NEA-backed Personal Genome Diagnostics receives FDA clearance for its cancer diagnostic | 4/28/2020

Jonathan Shieber @jshieber / 20 hours Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test. The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to …

Alex Azar

The coronavirus enemy remained ‘invisible’ because the Trump administration didn’t make the effort to see it | Yahoo News | 4/28/2020

… Alex Azar, and wanted Pence to galvanize — and organize — the faltering effort. Pence asked Stephen Hahn, who heads the Food and Drug Administration (and who had clashed with Azar) to join the effort. Hahn’s charge was to “increase capacity, and do so rapidly,” according to an official on the White House coronavirus task force familiar with the episode, but would only speak on the condition of anonymity. The premium, that …

Priscilla Chan

A study backed by Mark Zuckerberg reveals companies are selling antibody tests for the coronavirus with big potential for error | 4/28/2020

… A study backed by the Chan Zuckerberg Biohub, a medical research center founded by Facebook CEO Mark Zuckerberg and Dr. Priscilla Chan, reveals that several tests that detect antibodies for the novel coronavirus have less … coronavirus tests more widely available during the pandemic, the US Food and Drug Administration said that companies could sell them without official approval . Since then, dozens have flooded the market, creating fear among some experts …

Charlie Baker

Mass General Gets $1M Pledge; Carell Thanks Hospital Workers | 4/27/2020

Massachusetts News Baker Wants Solid Antibody Tests, Weighs How to Reopen State Gov. Charlie Baker is pressing federal officials to ramp up efforts to determine which coronavirus antibody tests are reliable. By Associated Press , Wire … Press BOSTON (AP) — Gov. Charlie Baker is pressing the U.S. Food and Drug Administration to ramp up efforts to determine which coronavirus antibody tests are the most reliable. The tests look for the presence of …

Francis Collins

The Secret Group of Scientists and Billionaires Pushing Trump on a Covid-19 Plan | MSN | 4/27/2020

Food and Drug Administration and the Department of Veterans Affairs have already implemented specific recommendations, such as slashing manufacturing regulations and requirements for specific coronavirus drugs. National Institutes of Health Director Francis Collins told people this month that he agreed with most of the recommendations in the report, according to documents reviewed by The Wall Street Journal and people familiar with the matter. The report was delivered to cabinet members …

Henry Miller

How hydroxychloroquine toes the line between promise and ‘happy talk’ in the coronavirus fight | 4/25/2020

After weeks of polarizing debate over the use of two generic anti-malarial drugs, hydroxychloroquine and chloroquine, the Food and Drug Administration this week warned they were not “safe and effective” when used on COVID … globally — nearly 900,000 in the U.S. alone. Yet according to Henry Miller, founding director of the FDA’s Office of Biotechnology and a Senior Fellow at the Pacific Research Institute, Trump’s public advocacy of the treatment …