Food and Drug Administration

MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute Graft-versus-Host-Disease at the ASH 2019 Annual Meeting | Business Wire | 12/8/2019

… a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company’s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About MaaT Pharma MaaT Pharma, a clinical stage company, has established the most complete approach to restoring …

Karyopharm Presents XPOVIO® (Selinexor) and Eltanexor Data at the American Society of Hematology 2019 Annual Meeting | Globe Newswire | 12/8/2019

… proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. In addition to receiving accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and …

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Stemline Therapeutics Names Robert M. Francomano Chief Commercial Officer | 12/8/2019

… in the launches of Arimidex in the adjuvant setting, Faslodex for metastatic disease, and managing tamoxifen as it approached patent expiry. About ELZONRIS ® ELZONRIS ® (tagraxofusp), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the …

Biogen’s potentially game-changing Alzheimer’s drug still faces an uphill battle with the FDA | 12/8/2019

… firm closed up 3.41% on Thursday as analysts pointed to a lack of any new negatives compared with the aducanumab results released in October, which may increase the drug’s odds of approval with the Food and Drug Administration . The Cambridge, Massachusetts-based company still faces an uphill battle with the federal regulator, however. The data, presented at the Clinical Trials on Alzheimer’s Disease conference in San Diego, were somewhat mixed …

Kratom abuse on the rise at addiction treatment centers, expert says | 12/8/2019

… Slide Next Slide However, the National Institute on Drug Abuse reports that the substance can cause addiction, withdrawal symptoms and unpleasant side effects like loss of appetite, seizures and hallucinations. There are no U.S. Food and Drug Administration -approved uses for kratom, and the agency warns consumers not to use kratom because it “appears to have properties that expose users to the risks of addiction, abuse, and dependence.” Nonetheless, kratom …

Donald Trump achievements: Healthcare, welfare, and other social issues | 12/8/2019

… Legislation signed, 2018 May 30, 2018—President Trump signed the Right to Try Act of 2017 into law, which gave terminally ill patients the right to try experimental treatments without full approval from the Food and Drug Administration . [34] October 10, 2018—President Trump signed two bills into law, both of them banning “gag clauses” that disallow pharmacists from telling patients that they can pay less for prescriptions by not …

Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment | 12/8/2019

… neurological events with earlier use of steroids, further support our ongoing leadership in cell therapy and commitment to patient care.” Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise …

Kochland review: how the Kochs bought America – and trashed it | US news | The Guardian | 12/8/2019

… The party’s modest plans included the abolition of “Medicare, Medicaid, social security (which would be made voluntary), the Department of Transportation, the Federal Aviation Administration, the Environmental Protection Agency, the Department of Energy, the Food and Drug Administration , and the Consumer Product Safety Commission.” “The party,” Leonard writes, “also sought to privatize all roads and highways, to privatize all schools, to privatize all mail delivery” and, eventually, the “repeal of …

#KahliBuds How CBD Oil Impacts the Body Everything you need to… | 12/8/2019

… also pose risks. This article will explain what CBD is, its possible health benefits, how to use it, potential risks, and issues surrounding its legality in the United States. In June 2018, the country’s Food and Drug Administration (FDA) approved the prescription useTrusted Source of Epidiolex, a purified form of CBD oil, for treating two types of epilepsy. What is CBD oil? CBD is one of many compounds, known as …

Pain | 12/8/2019

… in with pills, but they tended to be relatively mild pain relievers like codeine and ibuprofen, and in rare cases a drug called Percocet (one of the first formulations of oxycodone, approved by the Food and Drug Administration in 1976). Then things began to change. In the 1990s, Jack Kevorkian, a Detroit pathologist who had previously advocated harvesting organs from death row inmates, began using his lethal-injection machine to …

M&C Communications helps CBD industry companies manage change with a strong communications plan | Globe Newswire | 12/8/2019

… action can rattle your customers, retail partners, and even your employees into questioning the safety of your product. Being prepared to respond authoritatively will help protect your brand’s integrity. On November 25, 2019, the Food and Drug Administration (FDA) issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has previously …

FDA Approves Israeli Device That Extracts Medical Results Based Off Drop Of Blood | 12/8/2019

FDA Approves Israeli Device That Extracts Medical Results Based Off Drop Of… FDA Approves Israeli Device That Extracts Medical Results Based Off Drop Of Blood December 8, 2019 0 The U.S. Food and Drug Administration has approved an Israeli startup device that can quickly extract results based off just a drop of blood. However, unlike the former startup Theranos, which falsely claimed that it could test for diseases based off …

Financialization of the U.S. Pharmaceutical Industry | 12/7/2019

… securing every possible advantage of government support for the industry while avoiding price regulation, PhRMA has become one of the most powerful lobbies in Washington, D.C. A major policy coup of PhRMA was the Food and Drug Administration Act of 1997, which removed any regulatory restriction on television broadcasting of drug information; allowed the drug companies to provide medical professionals with some information in peer-reviewed academic journals on the …

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk - Stocks News Feed | 12/7/2019

SILVER SPRING, Md. , Dec. 6, 2019 / PRNewswire / — The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC , of Yorba Linda, California , and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen , for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice …

Another half-measure for preventing HIV/AIDS transmission | Modern Healthcare | 12/7/2019

… of transmission that has edged down only slightly over the past seven years. Public health officials now believe the best approach for preventing new infections is a once-a-day pill approved by the Food and Drug Administration in 2012. Truvada, the pre-exposure prophylaxis, or PrEP, pill manufactured by Gilead Sciences, is over 90% effective. However, it now costs roughly $20,000 a year, more than double what Gilead charged …

Axcella Presents Data at ASH Annual Meeting | Business Wire | 12/7/2019

… approach, the clinical development and safety profile of the company’s product candidates and their health or therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, the company’s liquidity, its ability to successfully develop product candidates through current and future milestones on the anticipated timeline, if at …

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis | Business Wire | 12/7/2019

… of AL amyloidosis. About NINLARO TM (ixazomib) capsules NINLARO™ (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently …

Sangamo and Pfizer Announce Updated Phase 1/2 Results Showing Sustained Increased Factor VIII Activity Through 44 Weeks Following SB-525 Gene Therapy Treatment | Business Wire | 12/7/2019

… the safety and tolerability of SB-525 in patients with severe hemophilia A. The mean age of the 11 patients assessed is 30 years (range 18-47 years). All 11 patients are male. The U.S. Food and Drug Administration has granted Orphan Drug, Fast Track, and regenerative medicine advanced therapy (RMAT) designations to SB-525, which also received Orphan Medicinal Product designation from the European Medicines Agency. SB-525 is being …

Epizyme Presents Updated Phase 2 Data at the 2019 ASH Annual Meeting Supporting Planned Tazemetostat NDA Submission for Follicular Lymphoma | Business Wire | 12/7/2019

… in both FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54). The IRC assessment was conducted for inclusion in Epizyme’s planned NDA submission to the U.S. Food and Drug Administration (FDA) in December 2019. As assessed by the IRC, as of an August 9, 2019 data cutoff date, tazemetostat treatment resulted in: Objective response rate (ORR) of 69% for patients with an …

Stoke Therapeutics Presents Preclinical Data From Studies of STK-001 That Showed Improvements in Survival and Reductions in Seizure Frequency in a Mouse Model of Dravet Syndrome | Business Wire | 12/7/2019

… of seizures and significant non-seizure comorbidities. Stoke has generated preclinical data demonstrating proof-of-mechanism and proof-of-concept for STK-001. STK-001 has been granted orphan drug designation by the U.S. Food and Drug Administration as a potential new treatment for Dravet syndrome. Stoke plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration in early 2020. About Dravet Syndrome Dravet …

CDC

Kratom abuse on the rise at addiction treatment centers, expert says | 12/8/2019

… Robinson , Pensacola News Journal Published 1:39 p.m. ET Dec. 7, 2019 Updated 2:04 p.m. ET Dec. 7, 2019 CLOSE The CDC says kratom, an herbal supplement, was a cause of deaths in 91 fatal overdoses … loss of appetite, seizures and hallucinations. There are no U.S. Food and Drug Administration-approved uses for kratom, and the agency warns consumers not to use kratom because it “appears to have properties that expose …

Pain | 12/8/2019

… and ibuprofen, and in rare cases a drug called Percocet (one of the first formulations of oxycodone, approved by the Food and Drug Administration in 1976). Then things began to change. In the 1990s, Jack … JAMA Network Open , this marketing correlated with overdose deaths. The CDC has thoroughly documented the rapid rise in opioid prescriptions and deaths since 1999. Many doctors listened to the marketing campaign. In our hubris, we …

Medicare

Donald Trump achievements: Healthcare, welfare, and other social issues | 12/8/2019

… of 2017 into law, which gave terminally ill patients the right to try experimental treatments without full approval from the Food and Drug Administration . [34] October 10, 2018—President Trump signed two bills into law … The HHS announced it would allow insurers participating in the Medicare Advantage program to negotiate with pharmaceutical companies to lower drug prices. [40] August 29, 2018—The Centers for Medicare and Medicaid Services moved to …

Pain | 12/8/2019

… and ibuprofen, and in rare cases a drug called Percocet (one of the first formulations of oxycodone, approved by the Food and Drug Administration in 1976). Then things began to change. In the 1990s, Jack … health-care delivery, not the health of the population, and Medicare-for-all wouldn’t address this problem. But one fix is for insurers to scrub the rules that make it cheaper for patients to continue …

Clinical Research

Stemline Therapeutics Names Robert M. Francomano Chief Commercial Officer | 12/8/2019

… managing tamoxifen as it approached patent expiry. About ELZONRIS ® ELZONRIS ® (tagraxofusp), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of … of third-party businesses, including, but not limited to, manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the …

Drug discovery and development: Health care stocks in Australia | 12/7/2019

… development: Health care stocks in Australia Drug development is an extensive process and includes drug discovery & development, pre-clinical and clinical research and FDA approvals, including Post-Market Drug Safety Monitoring. The first and the … prior to submitting an Investigational New Drug Application to the Food and Drug Administration (FDA), and in 2020 it would start clinical trials. Want to know more about NNZ-2591? Click here The company has …

Medicaid

Donald Trump achievements: Healthcare, welfare, and other social issues | 12/8/2019

… of 2017 into law, which gave terminally ill patients the right to try experimental treatments without full approval from the Food and Drug Administration . [34] October 10, 2018—President Trump signed two bills into law … prices. [40] August 29, 2018—The Centers for Medicare and Medicaid Services moved to give Medicare drug plans more choices they could offer to customers in order to lower drug prices. [41] October 4, 2018 …

Kochland review: how the Kochs bought America – and trashed it | US news | The Guardian | 12/8/2019

… Medicaid, social security (which would be made voluntary), the Department of Transportation, the Federal Aviation Administration, the Environmental Protection Agency, the Department of Energy, the Food and Drug Administration, and the Consumer Product Safety Commission.” “The party,” Leonard writes, “also sought to privatize all roads and highways, to privatize all schools, to privatize all mail delivery” and, eventually, the “repeal of all taxation”. Such political ambitions never got very far …

Mental Health

Donald Trump achievements: Healthcare, welfare, and other social issues | 12/8/2019

… of 2017 into law, which gave terminally ill patients the right to try experimental treatments without full approval from the Food and Drug Administration . [34] October 10, 2018—President Trump signed two bills into law … Administration gave more flexibility to the states to provide inpatient mental health treatment for individuals. [46] November 29, 2018—The Trump Administration announced four ways it would give waivers to the states so they could …

Endocannabinoids | 12/7/2019

… activated CB1 receptors mitigate anxiety, stress, pain, inflammation, depression, post-traumatic stress symptoms, and neurogenerative disorders. CB2 activation mitigates inflammation, mental health disorders, neurologic disorders, and multiple sclerosis. Cannabinoids are chemical compounds that can influence … 9-tetrahydrocannabinol (THC) and cannabidiol (CBD). In 2018 the FDA (Food and Drug Administration) approved a medication called Epidiolex, an oral solution of plant-derived CBD for treatment of seizures in Lennox-Gastaut and Dravet …

Medical Research

GOOD NEWS FROM AMAZING ISRAEL WHERE #ALL LIVES MATTER! FROM MICHAEL ORDMAN | 12/8/2019

GOOD NEWS FROM AMAZING ISRAEL WHERE ALL LIVES MATTER! FROM MICHAEL ORDMAN Israelis and Israeli innovations that save lives are so prominent in this week’s positive Israel newsletter. Medical research breakthroughs and programs; vital medical devices and emergency responders; global initiatives to reduce hunger, poverty and drought; rescue operations, doctors and surgeons treating non-Israelis overseas; technology to prevent plane crashes, maintain emergency services and reduce CO2 levels; and organizations …

5G Comes to New York City Despite Poor Understanding of Health and Environmental Impacts | 12/7/2019

… wireless radiation. There are no safety standards for exposure in the USA. Both the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA) have had disclaimer statements on their websites that read “there … Dr. Zorach Glaser, from 1971, commissioned by the US Naval Medical Research Institute, which summarized over 3,700 papers on the biological effects of these waves. Unfortunately, the FCC guidelines do not take into account any …

Digital Health

GOOD NEWS FROM AMAZING ISRAEL WHERE #ALL LIVES MATTER! FROM MICHAEL ORDMAN | 12/8/2019

GOOD NEWS FROM AMAZING ISRAEL WHERE ALL LIVES MATTER! FROM MICHAEL ORDMAN Israelis and Israeli innovations that save lives are so prominent in this week’s positive Israel newsletter. Medical research breakthroughs and programs; vital medical devices and emergency responders; global initiatives to reduce hunger, poverty and drought; rescue operations, doctors and surgeons treating non-Israelis overseas; technology to prevent plane crashes, maintain emergency services and reduce CO2 levels; and organizations …

Dr. Google Will See You Now | 12/7/2019

… wonder whether the data they acquire with the purchase of Fitbit will be sold to employers, insurance companies, financial firms, and whoever is interested in knowing about your health and disease status. As digital health expert and journalist Bruce Y. Lee writes in Forbes , “health data reveals what you can and cannot do, your vulnerabilities, limitations, or what others may view as such.” What if you are deemed an ‘algorithmic …

Gut Microbiome

MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute Graft-versus-Host-Disease at the ASH 2019 Annual Meeting | Benzinga | 12/8/2019

… where there are no other available treatments after steroids and additional lines of treatment. These findings indicate that reestablishing the gut microbiome improved outcomes in these patients.” Moreover, MaaT Pharma is currently conducting the HERACLES … MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About MaaT Pharma MaaT Pharma, a …

MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute Graft-versus-Host-Disease at the ASH 2019 Annual Meeting | Business Wire | 12/8/2019

… where there are no other available treatments after steroids and additional lines of treatment. These findings indicate that reestablishing the gut microbiome improved outcomes in these patients.” Moreover, MaaT Pharma is currently conducting the HERACLES … MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About MaaT Pharma MaaT Pharma, a …

Regenerative Medicine

Drug discovery and development: Health care stocks in Australia | 12/7/2019

… is into development and non-clinical studies which are required prior to submitting an Investigational New Drug Application to the Food and Drug Administration (FDA), and in 2020 it would start clinical trials. Want to … care company Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine company, which is into the development of new cellular therapies which target significant unmet medical needs. The key therapeutic areas of the company …

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk - Stocks News Feed | 12/7/2019

SILVER SPRING, Md. , Dec. 6, 2019 / PRNewswire / — The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC , of Yorba Linda, California , and their presidents and chief executive officers, Roya … highlighted in 2017 with the release of the FDA’s comprehensive regenerative medicine policy framework , including the FDA’s final guidance ( Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous …

Population Health

FLASHBACK: Vaccine boom, population bust: Study queries the link between HPV vaccine and soaring infertility | 12/7/2019

… in 2007, to 105 in 2015 for the cohort aged 25 to 29. The HPV vaccine was approved by the Food and Drug Administration for use in the US in 2006 to prevent cervical cancer … that further research was urgently required…. for the purposes of population health and public vaccine confidence. DeLong had read a case study in the British Medical Journal by Australian physicians Deirdre Little and Harvey Ward …

There’s Nothing Wrong With US Health Care That Less Money Couldn’t Fix | Health Affairs | 12/6/2019

… version of international pharmaceutical price indexing points to shared concern over this area of spending. Reform of US patent law, Food and Drug Administration rules, and other uniquely American legal, regulatory, and insurance structures could … Prioritize primary care . Primary care is consistently associated with better population health , yet compensation and investment in training have shifted away from primary care to specialist care. Potential strategies for restoring precedence to primary care …

Biogen

Reuters Health News Summary | Yahoo News | 12/7/2019

Biogen Inc built a case for its Alzheimer’s drug, which it had previously planned to shelve on the basis of a futility analysis that suggested the trials would not meet their goals. FDA approves Amgen’s biosimilar to J&J’s rheumatoid arthritis drug The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, according to the regulator’s website. The biosimilar …

New Biogen Data Showed no Major Safety Issues for its Alzheimer’s Drug - New Delhi Times - India’s Only International Newspaper | 12/7/2019

Biogen Inc on Thursday presented new data on its experimental Alzheimer’s drug aducanumab that eased concerns raised by some experts but still left many questions unanswered as the company made its case about why it … would affect how the drug is reviewed by the U.S. Food and Drug Administration (FDA), likely in the second half of 2020. It has been at least 15 years since the FDA has reviewed an …

Amarin

4 FDA Dates Biotech Investors Should Circle in December | The Motley Fool | 12/7/2019

… about whatever catches his interest no matter the industry. A number of biotech companies are awaiting responses from the U.S. Food and Drug Administration (FDA) this month. If granted approval from the agency, it wouldn’t … FDA give it a seal of approval. 4. December 28: Amarin’s fish oil drug Vascepa Amarin ( NASDAQ:AMRN ) received a piece of good news in November when a preliminary FDA advisory committee gave the fish …

The World Is Getting Better. It’s Just That No One Tells You About It. | 12/7/2019

Amarin “shocked the world last year when a long-running clinical trial showed that its medicine derived from purified fish oil, Vascepa, substantially reduced the risk of cardiovascular events like heart attacks in high-risk patients . . . In November, a panel of experts convened by the Food and Drug Administration reviewed Amarin’s data. They voted 16 to 0 that Vascepa was safe and cuts cardiovascular events.” Five: The Mayo Clinic injected …

Biogen Inc.

Reuters Health News Summary | Yahoo News | 12/7/2019

… had previously planned to shelve on the basis of a futility analysis that suggested the trials would not meet their goals. FDA approves Amgen’s biosimilar to J&J’s rheumatoid arthritis drug The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, according to the regulator’s website. The biosimilar, Avsola, has the same chemical components, dosage form and strength as …

New Biogen Data Showed no Major Safety Issues for its Alzheimer’s Drug - New Delhi Times - India’s Only International Newspaper | 12/7/2019

… approval after declaring the drug a failure in March. Experts had been watching closely for any statistical abnormalities or excess safety issues that would affect how the drug is reviewed by the U.S. Food and Drug Administration (FDA), likely in the second half of 2020. It has been at least 15 years since the FDA has reviewed an application for a new Alzheimer’s treatment, and an agent that can slow …

CVS

CVS CEO Merlo on the Company’s Future One Year After Aetna Acquisition | Fortune | 12/6/2019

… the top health care news. To get it delivered daily to your in-box, sign up here . Happy Friday, readers! CVS is celebrating a big milestone this week: The one-year anniversary of the mammoth … drugs slated to face generic competition—at some point. The Food and Drug Administration (FDA) has approved multiple generic rivals to Novartis’ $3 billion-per-year multiple sclerosis treatment Gilenya; however, as is a recurring …

HHS Hands Out Free HIV Prevention Drugs. Do You Qualify? | Kaiser Health News | 12/4/2019

… 30- or 60-day supply of whichever drug their doctor prescribed. The drugs will be available in at least 21,000 CVS, Walgreens and Rite Aid locations. Both medications are once-a-day pills. /p p … p p Dr. Brett Giroir, the acting commissioner of the Food and Drug Administration, said officials estimate that up to 200,000 people who could benefit from PrEP don’t have insurance. /p p “We certainly believe …

Apple Health

How Ochsner Health Uses the Apple Watch to Keep Patients Healthy | 12/6/2019

Jen A. Miller is author of Running: A Love Story. Her work has appeared in The New York Times, Washington Post, CIO Dive, Supply Chain Dive. and Runner’s World. She lives in N.J. with her dog Annie Oakley. Listen Pause Commercially available for five years, the Apple Watch received clearance from the U.S. Food and Drug Administration in 2018 for its electrocardiogram function, which employs machine learning and individual algorithms …

KHN’s ‘What The Health?’: We Spend HOW MUCH On Health Care? | Kaiser Health News | 12/5/2019

… of the department. A Senate committee this week approved the nomination of Stephen Hahn to be the head of the Food and Drug Administration. Although some senators raised questions about the White House’s apparent step … hear all our What the Health? on a href=”https://itunes.apple.com/us/podcast/what-the-health/id1253607372?mt=2” iTunes /a , a href=”http://www.stitcher.com/podcast/kaiser-health-news/what-the-health” Stitcher /a , a …

McKesson

‘SELL BABY SELL!’: Unsealed documents in opioids lawsuit reveal inner workings of industry’s marketing machine - The Washington Post | 12/6/2019

… its opioid-manufacturing subsidiary Janssen, said in a statement to The Post that its products had been approved by the Food and Drug Administration and that its sales representatives were properly trained. “Janssen did what … for more than $325 million by multiple drug companies, including McKesson Corp., Cardinal Health, AmerisourceBergen, Johnson & Johnson, Mallinckrodt and Teva Pharmaceutical Industries. The remaining 2,500 cases, as well as lawsuits filed by most of the …

‘SELL BABY SELL’: Inside the opioid industry’s marketing machine - SFGate | The Washington Post | 12/6/2019

… its opioid-manufacturing subsidiary Janssen, said in a statement to The Post that its products had been approved by the Food and Drug Administration and that its sales representatives were properly trained. “Janssen did what … for more than $325 million by multiple drug companies, including McKesson Corp., Cardinal Health, AmerisourceBergen, Johnson & Johnson, Mallinckrodt and Teva Pharmaceutical Industries. The remaining 2,500 cases, as well as lawsuits filed by most of the …

Zogenix

Worldwide Chronic Disease Management Industry Insights, 2018-2024: Emphasis on Advance Needle-Free Drug Delivery Technologies, Diagnostic Methods, and Smart Device Technologies | Benzinga | 12/6/2019

Zogenix Inc. Zydus Cadila Chapter 14 Appendix A: List of Acronyms Chapter 15 Appendix B: Professional Organizations American Heart Association Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Centers for Medicare and Medicaid Services (CMS) European Databank for Medical Devices (EUDAMED) Food and Drug Administration (FDA or USFDA) Hormone Foundation International Diabetes Federation (IDF) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Network for …

Global Chronic Disease Management Markets to 2024, Featuring Profiles of Leading Players Roche, AbbVie, Johnson & Johnson, Bristol-Myers Squibb, Merck, GlaxoSmithKline, and More | The Wapakoneta Daily News | 12/3/2019

Zogenix Inc. Zydus Cadila Chapter 14 Appendix A: List of Acronyms Chapter 15 Appendix B: Professional Organizations American Heart Association Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Centers for Medicare and Medicaid Services (CMS) European Databank for Medical Devices (EUDAMED) Food and Drug Administration (FDA or USFDA) Hormone Foundation International Diabetes Federation (IDF) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Network for …

Edwards Lifesciences

Worldwide Chronic Disease Management Industry Insights, 2018-2024: Emphasis on Advance Needle-Free Drug Delivery Technologies, Diagnostic Methods, and Smart Device Technologies | Benzinga | 12/6/2019

… Oncology Connectedhealth Pte. Ltd. Corbus Pharmaceuticals Cspc Pharmaceutical Group Daiichi Sankyo Dexcom Inc. Depomed Inc. Dr. Reddy’s Laboratories Ltd. Earlysense Edwards Lifesciences Corp. Eisai Eli Lilly Empatica Endo International Endotronix Entra Health Systems Endoceutics Inc … and Medicaid Services (CMS) European Databank for Medical Devices (EUDAMED) Food and Drug Administration (FDA or USFDA) Hormone Foundation International Diabetes Federation (IDF) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Network for Excellence in …

Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference | PR Newswire | 12/5/2019

NEW YORK Edwards Lifesciences Corporation (NYSE: EW ), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, will discuss the company’s strategy for longer-term growth, provide an update on … R&D and clinical trials; unanticipated actions by the U.S. Food and Drug Administration and other regulatory agencies; unexpected litigation impacts or expenses, particularly in our TAVR patent litigation; unpredictability of changes in accounting standards …

Theranos

12/05 Link Pt2: Bari Weiss: Inconvenient Murders; Corbyn fans accidentally admit he’s racist; The Tikvah Podcast: Why No One Cares about Violence Directed at the Orthodox | 12/6/2019

… Theranos, startup’s blood test device ‘delivers on promise’ with FDA nod Israeli startup Sight Diagnostics has received US Food and Drug Administration clearance to market a blood test device that can extract the results of a standard complete blood count test from just a drop of blood in minutes. The FDA approval was given following clinical trials held at Boston Children’s Hospital, Columbia University Medical Center and TriCore Labs. The …

FDA Approves Israeli Device That Extracts Medical Results Based Off Drop of Blood | 12/6/2019

A diabetes patient testing their blood sugar level. Photo: Reversing Your Diabetes Today via Wikicommons. JNS.org – The US Food and Drug Administration has approved an Israeli startup device that can quickly extract results based off just a drop of blood. However, unlike the former startup Theranos, which falsely claimed that it could test for diseases based off blood from the prick of a finger (and whose founder and deputy were …

BioXcel Therapeutics

Worldwide Chronic Disease Management Industry Insights, 2018-2024: Emphasis on Advance Needle-Free Drug Delivery Technologies, Diagnostic Methods, and Smart Device Technologies | Benzinga | 12/6/2019

… Astrazaneca Plc Astellas Pharma Inc. Athersys Audentes Therapeutics Axiobionics Axsome Therapeutics Ayogo Health Bausch Health Bayer Ag Bespak Europe Beigene Bioxcel Therapeutics Biosensics Bioserenity Biotronik Gmbh Biotricity Biovotion Bodytel Boehringer Ingelheim Boston Scientific Bristol- Myers … and Medicaid Services (CMS) European Databank for Medical Devices (EUDAMED) Food and Drug Administration (FDA or USFDA) Hormone Foundation International Diabetes Federation (IDF) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Network for Excellence in …

BioXcel Therapeutics Prepares to Initiate Pivotal Phase 3 Studies with BXCL501 Following Positive End-of-Phase 2 Meeting with FDA | Globe Newswire | 12/3/2019

BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced it has reached a general agreement with the U.S. Food and Drug Administration (FDA) on the key elements of the designs for its SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With SchizophRENIa and Bipolar Disorder STudY) program, two …

Longitude Capital

Talaris Therapeutics to Present at American Society of Hematology (ASH) Annual Meeting | 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 …

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 …

Goldman Sachs

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 … chief operating officer of Twitter and former managing director at Goldman Sachs — has taken over and shown interest in SoFi entering the cryptocurrency game . Scooter and bike rental startup Lime is valued at $2.4 billion …

30 companies worth at least $1 billion that didn’t exist 10 years ago | Markets Insider | Business Insider | 12/3/2019

… 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 … chief operating officer of Twitter and former managing director at Goldman Sachs - has taken over and shown interest in SoFi entering the cryptocurrency game . Scooter and bike rental startup Lime is valued at $2.4 billion …

SVB Leerink

Gene therapy is facing its biggest challenge yet | Nature | 12/4/2019

… awareness in wealthier nations, says Wonkam. There are signs that this attention is paying off. On 25 November, the US Food and Drug Administration approved a drug for sickle-cell that aims to reduce clumping … lifetime, says Mani Foroohar, an analyst at the investment bank SVB Leerink in Boston, Massachusetts. Also, Bluebird Bio has established an unusual fee structure: payments are made over the course of five years, and can …

3 December - Blogs I’m Following - 5 of 5 | 12/4/2019

… to cereal, CBD companies News Desk at Food Safety News - 22 hours ago As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are … 70 new drugs, according to a Friday morning note from SVB Leerink analyst Andrew Berens. Drugmakers with discounted products included on the list include AbbVie (ticker: ABBV), Gilead (GILD), Johnson & Johnson (JNJ), and AstraZeneca (AZN …

Khosla Ventures

Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors | PR Newswire | 12/4/2019

… and robotics for minimally invasive surgical treatments, announced today they were recently granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). (PRNewsfoto/Vicarious Surgical) The FDA Breakthrough Devices Program is intended … and physicians, and backed by technology luminaries including Bill Gates , Khosla Ventures, Eric Schmidt’s Innovation Endeavors, Jerry Yang’s AME Cloud Ventures, and Marc Benioff . Contact: [email protected] SOURCE Vicarious Surgical Related Links https://www.vicarioussurgical.com …

Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors | Markets Insider | Business Insider | 12/4/2019

… and robotics for minimally invasive surgical treatments, announced today they were recently granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The FDA Breakthrough Devices Program is intended to help patients … and physicians, and backed by technology luminaries including Bill Gates , Khosla Ventures, Eric Schmidt’s Innovation Endeavors, Jerry Yang’s AME Cloud Ventures, and Marc Benioff . Contact: [email protected] View original content to download multimedia:https://www.prnewswire.com …

Omega Funds

Anaconda Biomed S.L. Secures €20 Million Round of Funding | BioSpace | 12/4/2019

… led the round from its fund, Sabadell Asabys Health Innovation Investments SCR, SA, with participation from existing investors Ysios Capital , Omega Funds and Innogest , as well as Sabadell Venture Capital, who joined the previous financing … be used to support a regulatory submission to the U.S. Food and Drug Administration. About Asabys Partners Sabadell Asabys Health Innovation Investments SCR, SA is a venture capital vehicle managed by Asabys Partners, a firm …

Imago BioSciences Further Expands Executive Team with Appointment of James D. Watson as Chief Business Officer | 11/4/2019

… across a range of myeloid malignancy models including the myeloproliferative neoplasms encompassing myelofibrosis, essential thrombocythemia and polycythemia vera. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bomedemstat for the treatment … a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron, Greenspring Associates and Xeraya Capital …

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 …

Abilitech Closes on $7.4M Fundraise - Twin Cities Business | 12/3/2019

… Minnesota Cup competition in October – has closed on a $7.4 million investment round. The three largest investors were Bios Partners, DEFTA Partners, and EFO Holdings. Minnesota investors included the SE MN Capital Fund and the … into 2021. The company hasn’t yet gained clearance from the Food and Drug Administration, but it expects to receive that in 2020. “We’ve watched Abilitech for three years and witnessed its team cross a threshold …

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 …

30 companies worth at least $1 billion that didn’t exist 10 years ago | Markets Insider | Business Insider | 12/3/2019

… 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 …

Morgan Stanley

PHILIP MORRIS INTERNATIONAL INC. PRESENTS AT THE MORGAN STANLEY GLOBAL CONSUMER & RETAIL CONFERENCE | Business Wire | 12/3/2019

… s (“PMI”) (NYSE: PM) Chief Executive Officer, André Calantzopoulos, and Chief Financial Officer, Martin King, address investors today at the Morgan Stanley Global Consumer & Retail Conference in New York. The presentation and Q&A session … Platform 1 device and its consumables authorized by the U.S. Food and Drug Administration to Altria Group, Inc. for sale in the United States under license. PMI is building a future on a new category …

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 …

Impulse Dynamics Raises $80.25M in Series D Financing | 12/3/2019

… for heart failure, closed an $80.25m Series D financing. The round was led by Amzak Health Investors, with participation from 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. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart …

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 …

Juul disregarded early evidence it was hooking teens | 11/12/2019

… e-cigarettes in the previous month. The measures to prevent youth sales and use came two days after the U.S. Food and Drug Administration (FDA) announced a nationwide crackdown on underage sales of Juul products … 46.7 million funding round that included investments from stalwarts like Fidelity Investments and Tao Capital Partners, a fund run by former Hyatt hotels chain executive Nicholas Pritzker, who served on the e-cigarette startup’s board …

Premier Health

First investigational drug therapy for liver disease NASH awaiting FDA approval | 12/6/2019

… the safety and effectiveness of an oral medication to treat the disease. The drug therapy is pending approval from the Food and Drug Administration. Findings from the interim analysis of the REGENERATE study, sponsored by … Children’s Hospital of Richmond at VCU, MCV Physicians and Virginia Premier Health Plan. For more, please visit http://www.vcu …

MD Anderson Cancer Center

The Gene Therapy Spree Rolls on With $3 Billion Astellas Deal | Fortune | 12/4/2019

… Legacy biopharma companies have been pursuing these gene therapy bolt-on acquisitions at a rapid clip—especially after several major Food and Drug Administration (FDA) approvals for pioneering (though, in some cases, controversially expensive treatments … confirmation later this year. But Dr. Stephen Hahn of the MD Anderson Cancer Center faced some tough questions over his dedication to cracking down on the vaping and e-cigarette industry during his confirmation process …

First Edition: December 4, 2019 | Kaiser Health News | 12/4/2019

… Food and Drug Administration, the agency responsible for combating a recent wave of underage vaping. The Senate’s health committee voted 18-5 to advance the nomination of Dr. Stephen Hahn, a cancer specialist and medical executive at the MD Anderson Cancer Center in Houston. Several Democrats opposed Hahn for the role, worrying he would not be tough enough tackling the vaping problem among teenagers. (12/3) The New York Times: F.D.A. Nominee …

Mayo Clinic

Visiongain Report Provides Critical Market-led Data on the 57bn Biomarkers Market | PR Newswire | 12/4/2019

… of QIAGEN) Isogen Life Science Johnson & Johnson (J&J) KU Leuven (University of Leuven) LabCorp Life Technologies LightArray Biotech M2Gen Mayo Clinic [US] Mayo Collaborative Services MDxHealth Medical Research Council [UK] MediMedia Pharma Solutions Memorial … Centers for Medicare and Medicaid Services (CMS) [US] Chinese State Food and Drug Administration (SFDA) Commonwealth Scientific and Industrial Research Organisation (CSIRO) [ Australia ] EMA (European Medicines Agency) ETH Zurich European Commission European Federation of Pharmaceutical …

More U.S. women know how breast density impacts cancer risk | 12/4/2019

… than the (patient), regardless of whether the (patient) reported having dense breasts,” lead study author Dr. Deborah Rhodes of the Mayo Clinic in Rochester, Minnesota, and colleagues write. “Among those who reported having dense breasts … in dense breast tissue. A new proposal from the U.S. Food and Drug Administration, announced March 28, would require all mammography facilities in the U.S. to include breast density information in letters to patients. The …

Harvard Medical School

23 and Baby | Nature | 12/4/2019

… signs of disease. For this study, called the BabySeq Project, Robert Green of Brigham and Women’s Hospital, Alan Beggs of Harvard Medical School and their colleagues recruited families and randomly assigned half of them to … about the child’s sensitivity to certain drugs, although the U.S. Food and Drug Administration has recently been pressuring companies not to make such information available, because it says that it has not reviewed the tests …

CBD oil items abound, but do they in fact work? Some say yes while specialists urge care | 12/3/2019

… illustration) ‘Claims outpacing the science’ “We don’t understand yet just what it really works for,” said Dr. Peter Grinspoon, a Harvard Medical School teacher on staff at Massachusetts General Hospital. “That’s not saying it does … and products to deal with health conditions. And so the Food And Drug Administration is keeping a general public hearing the following month to assemble information linked to product safety and has now created an …

Massachusetts General Hospital

Visiongain Report Provides Critical Market-led Data on the 57bn Biomarkers Market | PR Newswire | 12/4/2019

Food and Drug Administration (SFDA) Commonwealth Scientific and Industrial Research Organisation (CSIRO) [ Australia ] EMA (European Medicines Agency) ETH Zurich European Commission European Federation of Pharmaceutical Industries and Associations (EFPIA) European Medicines Agency (EMA) European Stroke Research Network for Hypothermia (Euro-HYP) Food and Drug Administration (FDA) [US] Hirosaki University Human Proteome Organisation (HUPO) International Cancer Genome Consortium (ICGC) Les entreprises du médicament (LEEM) [ France ] Malmö University Massachusetts General Hospital Max …

CBD oil items abound, but do they in fact work? Some say yes while specialists urge care | 12/3/2019

… understand yet just what it really works for,” said Dr. Peter Grinspoon, a Harvard Medical School teacher on staff at Massachusetts General Hospital. “That’s not saying it does not. Just he added that it hasn’t … and products to deal with health conditions. And so the Food And Drug Administration is keeping a general public hearing the following month to assemble information linked to product safety and has now created an …

Cleveland Clinic

Levita Magnetics Reaches 1,000th Magnetic Surgery Milestone | 12/4/2019

… peers face when trying to gain proper access to organs.” In addition to Duke University, major healthcare institutions including the Cleveland Clinic, UT Southwestern, and others have performed various surgical procedures using Magnetic Surgery. The … It is the first magnetic surgical system to receive U.S. Food and Drug Administration clearance …

Calculating the Costs of Clinical Trials | 12/1/2019

… trial access,” he added. The period between a clinical trial ending and a drug receiving marketing approval from the U.S. Food and Drug Administration (FDA) is a vulnerable time for patients. “Sometimes that bridging, that … Clinical News and director of the Leukemia Program at the Cleveland Clinic, recalled the devastating moment experienced by many patients when, “after devoting themselves to the trial requirements and jeopardizing their own health for the …

Memorial Sloan Kettering Cancer Center

Visiongain Report Provides Critical Market-led Data on the 57bn Biomarkers Market | PR Newswire | 12/4/2019

… Cardiology Foundation (ACCF) American Heart Association (AHA) Association for Molecular Pathology (AMP) [US] British Heart Foundation [UK] Broad Institute [US] Cancer Research UK Centers for Medicare and Medicaid Services (CMS) [US] Chinese State Food and Drug Administration (SFDA) Commonwealth Scientific and Industrial Research Organisation (CSIRO) [ Australia ] EMA (European Medicines Agency) ETH Zurich European Commission European Federation of Pharmaceutical Industries and Associations (EFPIA) European Medicines Agency (EMA) European Stroke Research Network …

Rafael Pharmaceuticals Announces Expansion of Phase 2 Trial of CPI-613® (devimistat) for Patients with Relapsed or Refractory Burkitt’s Lymphoma/Leukemia to Massachusetts General Hospital in Boston | Globe Newswire | 12/2/2019

… trial will begin enrolling patients at Massachusetts General Hospital in Boston starting this month. The trial is currently underway at Memorial Sloan Kettering Cancer Center in New York City and at City of Hope in … for the treatment of relapsed Burkitt’s lymphoma from the U.S. Food and Drug Administration (FDA). Orphan drug designation refers to a special status granted by The Orphan Drug Act (ODA) to a drug used to …

Kaiser Permanente

HHS Hands Out Free HIV Prevention Drugs. Do You Qualify? | Kaiser Health News | 12/4/2019

… last year, the Centers for Disease Control and Prevention reported. /p p Dr. Brett Giroir, the acting commissioner of the Food and Drug Administration, said officials estimate that up to 200,000 people who could benefit … J. Kaiser Family Foundation /a which is not affiliated with Kaiser Permanente. /p …

Bonner County Daily Bee - National News, HHS Hands Out Free HIV Prevention Drugs. Do You Qualify? | 12/4/2019

… Food and Drug Administration, said officials estimate that up to 200,000 people who could benefit from PrEP don’t have insurance. “We certainly believe that this program will supply all those in need who are uninsured,” said Giroir. Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente

National Jewish Health

Visiongain Report Provides Critical Market-led Data on the 57bn Biomarkers Market | PR Newswire | 12/4/2019

… British Heart Foundation [UK] Broad Institute [US] Cancer Research UK Centers for Medicare and Medicaid Services (CMS) [US] Chinese State Food and Drug Administration (SFDA) Commonwealth Scientific and Industrial Research Organisation (CSIRO) [ Australia ] EMA (European … Infectious Diseases (NIAID) [US] National Institute on Aging ( NIA) [US] National Jewish Health [US] Newcastle University [UK] NIH (National Institute of Health) Oslo University Hospital Pharmaceutical Research and Manufacturers of America (PhRMA) Pharmaceuticals and Medical …

Clinic pitches unproven treatments to desperate patients, with tips on raising the cash - SFGate | 12/2/2019

… singled out for its aggressive marketing and unproven claims. In 2015, for example, pulmonologists at Johns Hopkins wrote to the Food and Drug Administration urging it to take action against the Lung Health Institute. “We … information is evidence of efficacy,” said Cosgrove, a pulmonologist at National Jewish Health in Denver, which runs one of the world’s largest interstitial lung disease programs. The company’s claims are “a nothing, a come on …

University of Texas MD Anderson Cancer Center

ASTRO congratulates Dr. Stephen Hahn for securing Senate committee approval to lead U.S. Food and Drug Administration | 12/3/2019

… Pensions voted today to approve the nomination of radiation oncologist Stephen Hahn, MD, FASTRO, as the next Commissioner of the Food and Drug Administration (FDA). Next, Senate Majority Leader Mitch McConnell (R-Ky.) will need … of Directors. Dr. Hahn, the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston, was nominated November 1 by President Trump to be the nation’s 24th FDA Commissioner. On behalf …

Senate Panel Backs Trump’s Pick to Run FDA | 12/3/2019

Senate Panel Backs Trump’s Pick to Run FDA The Senate’s health committee voted 18-5 to advance the nomination of Dr. Stephen Hahn. Matthew Perrone Dec 3rd, 2019 This 2014 photo provided by The University of Texas MD Anderson Cancer Center shows Stephen Hahn. President Donald Trump’s nominee to lead the Food and Drug Administration sidestepped questions on the future of a 2-month-old plan to ban most flavored e …

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 …

30 companies worth at least $1 billion that didn’t exist 10 years ago | Markets Insider | Business Insider | 12/3/2019

… 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 …

Alnylam Announces New and Enhanced Framework for Value-Based Agreements to Accelerate Patient and Provider Access to GIVLAARI™ (givosiran) – Company Announcement - FT.com | Financial Times | 11/20/2019

… 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 …

Aetna

Wednesday, November 20, 2019 | Kaiser Health News | 11/20/2019

… Stat: 12 Burning Questions For Stephen Hahn, Trump’s Pick To Lead FDA Stephen Hahn, President Trump’s nominee to helm the Food and Drug Administration, will today face his first real test in Washington — a confirmation … Making Progress Though its Medicaid contract is still at stake, Aetna Better Health is making progress, Kansas lawmakers and state regulators said this week. …State regulators had put Aetna on notice in July that it …

Solving Health Care | 11/8/2019

… Trump Administration to kill it, discouraging participation and suing to overturn the law. Others have taken notice. CVS Health bought Aetna to convert to managed care. They can do front-line care at pharmacies, using … It says doctors can prescribe any drug approved by the Food and Drug Administration, and that insurers – including Medicare – must pay. This is the problem. Drug companies advertise to consumers. They spent $3.7 billion on …

UnitedHealthcare

Meet the 34 DC healthcare power players who shape the rules for a $3.5 trillion industry that touches every American | 11/20/2019

… to put more women in healthcare leadership roles. Nicole Cooper Nicole Cooper is the vice president of social responsibility at UnitedHealthcare, the biggest US health insurer. Cooper leads national philanthropic grant-making and employee volunteer … interests on legislation such as the Affordable Care Act, the Food and Drug Administration Amendments Act, and other healthcare initiatives. Heafitz has worked at PCMA for more than a decade. Before that, he worked for …

Meet the power players of DC healthcare politics and policy - Business Insider | 11/13/2019

… which aims to put more women in healthcare leadership roles. Nicole Cooper Nicole Cooper, vice president of social responsibility at UnitedHealthcare. Photo courtesy of Dr. Nicole Cooper. Nicole Cooper is the vice president of social … interests on legislation such as the Affordable Care Act, the Food and Drug Administration Amendments Act, and other healthcare initiatives. Heafitz has worked at PCMA for more than a decade. Before that, he worked for …

Humana

The Manufacture of GMP-Grade Bone Marrow Stromal Cells with Validated In Vivo Bone-Forming Potential in an Orthopedic Clinical Center in Brazil | 11/7/2019

… to determine the average yield of cells at each step. Because ANVISA and international regulatory organizations, such as the US Food and Drug Administration (FDA), have recommended that reagents from animal sources should be avoided … vol. 1130 of Methods in molecular biology , pp. 279–293, Humana Press, Totowa, NJ, USA, 2014. View at Publisher · View at Google Scholar · View at Scopus V. F. Vianna, D. C. Bonfim, A. S. Cavalcanti …

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 …

Health Net

Decision point | 10/30/2019

… looking organizations are eager to embrace it. Lehigh Valley Physician Group (LVPG) in Allentown, Pennsylvania – part of the Lehigh Valley Health Network – is such a forward-looking organization. Last year, it transformed a challenge into … worst influenza outbreaks the U.S. had ever faced – the U.S. Food and Drug Administration announced it would reclassify an entire group of flu tests (called rapid influenza antigen detection tests, or RIDTs) because they didn’t …

Alphabet’s Verily collaborating with Atrius Health, Palo Alto VA on population health projects | FierceHealthcare | 10/24/2019

… Health Network and Premier Health to build a technology-focused rehab campus in Dayton, Ohio, to combat the opioid crisis. Alphabet also has recently added big healthcare names to its roster including former U.S. Food and Drug Administration Commissioner Robert Califf, M.D. , to lead its health strategy and policy across the company’s Google Health and Verily Life Sciences enterprises. The company also tapped former Obama administration health official Karen DeSalvo …

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 …

Herbalife Nutrition Announces Management Succession Plan | Business Wire | 10/29/2019

… for the U.S. Department of Health and Human Services. During his term, he was responsible for disease prevention and health promotion. He oversaw the Centers for Disease Control, National Institutes of Health, the Food and Drug Administration, the office of the U.S. Surgeon General, and numerous other public health offices and programs. In the private sector, Dr. Agwunobi served as Senior Vice President and President of Health and Wellness for …

Indian Health Service

Overview of Continuing Appropriations for FY2020 (P.L. 116-59) | 10/24/2019

… in the CR, congressional clients may contact the CRS appropriations experts, as noted in the accompanying footnote. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 15 Section 101(1)—Rural Water and Waste … by the Administration. Interior, Environment, and Related Agencies Section 136—Indian Health Service 61 This provision authorizes the apportionment of appropriations that are provided by the CR of up to $18.4 billion for the Indian …

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 …

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 …

Harvard Pilgrim Health Care Institute Funded up to $220 Million for the Next Phase of FDA Sentinel System | Malvern Daily Record | 10/1/2019

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 the Institute’s 10 years of experience developing and operating the Sentinel System, a national program that uses electronic health care data to monitor …

Carelink

Medtronic Recalls Certain Insulin Pumps; FDA Issues Warning | Markets Insider | Business Insider | 6/28/2019

Food and Drug Administration issued a warning that these insulin pumps hold potential cybersecurity risks. In a patient letter, Medtronic stated that the recalled insulin pumps are designed to communicate using a wireless radio frequency or RF with other devices. These devices include blood glucose meters, glucose sensor transmitters, and CareLink USB devices. It has been warned that an unauthorized person could potentially connect wirelessly to a nearby insulin pump …

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps | Markets Insider | Business Insider | 6/27/2019

SILVER SPRING, Md. , June 27, 2019 /PRNewswire/ – The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and … glucose meters, continuous glucose monitoring systems, the remote controller and CareLink USB device used with these pumps. The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient …

Janet Woodcock

FDA investigates diabetes drug for possible contamination with cancer-causing… | 12/8/2019

Janet Woodcock , director of the Center for Drug Evaluation and Research. The Food and Drug Administration announced Wednesday it was aware metformin in other countries contained low levels of NDMA, but those levels were in the “naturally occurring in food and water” range. NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of NDMA …

FDA Approves Generic Gilenya for Treatment of MS | 12/7/2019

Pat Anson By Pat Anson, PNN Editor The U.S. Food and Drug Administration has approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). That’s welcome news … treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having access to affordable treatments is important for …

Michel Vounatsos

Biogen’s potentially game-changing Alzheimer’s drug still faces an uphill battle with the FDA | 12/8/2019

… new negatives compared with the aducanumab results released in October, which may increase the drug’s odds of approval with the Food and Drug Administration. The Cambridge, Massachusetts-based company still faces an uphill battle with … is confident Despite the skepticism, Biogen is optimistic. Biogen CEO Michel Vounatsos told CNBC in October that he is “reasonably confident” the FDA will approve the Alzheimer’s drug. Vounatsos insisted that Biogen’s dosing of the …

Biogen’s Alzheimer’s drug still faces uphill battle with FDA | CNBC | 12/7/2019

… new negatives compared with the aducanumab results released in October, which may increase the drug’s odds of approval with the Food and Drug Administration . The Cambridge, Massachusetts-based company still faces an uphill battle with … is confident Despite the skepticism, Biogen is optimistic. Biogen CEO Michel Vounatsos told CNBC in October that he is “reasonably confident” the FDA will approve the Alzheimer’s drug. Vounatsos insisted that Biogen’s dosing of the …

Peter Marks

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk - Stocks News Feed | 12/7/2019

SILVER SPRING, Md. , Dec. 6, 2019 / PRNewswire / — The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC , of Yorba Linda, California , and their presidents and chief executive officers, Roya … misleading claims about their effectiveness for treating serious diseases,” said Peter Marks , M.D., Ph .D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA is taking this action today because Liveyon Labs …

FDA warns Liveyon for selling unapproved umbilical cord blood products - SFGate | 12/7/2019

WASHINGTON - The Food and Drug Administration announced Friday it had warned a Yorba Linda, California, company for making and selling unapproved products from umbilical cord blood, and for “significant deviations” from safety practices that create … misleading claims about their effectiveness for treating serious diseases,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The FDA is taking this action today because Liveyon Labs and Liveyon LLC …

Howard Fillit

New Biogen Data Showed no Major Safety Issues for its Alzheimer’s Drug - New Delhi Times - India’s Only International Newspaper | 12/7/2019

… closely for any statistical abnormalities or excess safety issues that would affect how the drug is reviewed by the U.S. Food and Drug Administration (FDA), likely in the second half of 2020. It has been … about whether the drug has a clinical effect,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation, who was at the meeting. Fillit said the company only measured one timepoint – 78 …

Biogen’s Divisive Alzheimer’s Drug Has Broader Implications | Fortune | 12/6/2019

… Biogen presented more detailed data on its controversial therapy aducanumab , which the drug giant hopes will become the first-ever Food and Drug Administration (FDA) approved medicine to actually treat the disease rather than just … Drug Discovery Foundation (ADDF) citing the organization’s chief scientific officer Howard Fillit. Fillit goes on to say that beta-amyloid is just one part of the equation—and that effective Alzheimer’s treatment down the road …

Craig Tendler

IMBRUVICA® (ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leukemia | PR Newswire | 12/7/2019

… studies, IMBRUVICA demonstrated an OS benefit in untreated and relapsed patients with improved outcomes in early lines of therapy,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development … of the recent supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) to expand the IMBRUVICA ® label to include the combination with rituximab for the first-line treatment of patients with CLL …

IMBRUVICA® (ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leu… | Markets Insider | Business Insider | 12/7/2019

… studies, IMBRUVICA demonstrated an OS benefit in untreated and relapsed patients with improved outcomes in early lines of therapy,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development … of the recent supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) to expand the IMBRUVICA ® label to include the combination with rituximab for the first-line treatment of patients with CLL …

Nick Glover

Sierra Oncology Reports Decreased Transfusion Requirements for Patients Treated with Momelotinib Directly Compared to Ruxolitinib at ASH Annual Meeting – Company Announcement - FT.com | Financial Times | 12/7/2019

… of transfusions experienced by myelofibrosis patients treated with momelotinib versus ruxolitinib in a large, blinded, randomized, clinical trial,” said Dr. Nick Glover , President and CEO of Sierra Oncology . “Momelotinib uniquely inhibits ACVR1 in addition to … not approved for any use in any country. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received …

Joshua M. Sharfstein

Financialization of the U.S. Pharmaceutical Industry | 12/7/2019

… defends the profits of its corporate members by stressing the high cost of drug development: “From drug discovery through FDA [Food and Drug Administration] approval, developing a new medicine takes, on average, 10 to 15 … Designations and Approvals, “ at https://www.accessdata.fda.gov/scripts/opdlisting/oopd/ . [19] Joshua M. Sharfstein and Jeremy Greene, “Promise and Peril for Generic Drugs,” JAMA Internal Medicine , 176, 6, 2016: 733-734; Kerstin Noëlle Vokinger, Aaron S. Kesselheim …

Study: Some Brain Supplements Contain Non-Approved Drugs | Everyday Health | 11/27/2019

Food and Drug Administration (FDA) decision. Dr. Cohen and colleagues found five brands of supplements available for purchase that contained the unapproved substance piracetam. “These findings reveal that the market for dietary supplements remains risky for consumers,” says Joshua M. Sharfstein, MD , a former principal deputy commissioner of the FDA and the current vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health …

Julie Kanter

bluebird bio Presents New Data from Ongoing Phase 1/2 HGB-206 Study of LentiGlobin™ Gene Therapy for Sickle Cell Disease (SCD) at 61st ASH Annual Meeting and Exposition | Business Wire | 12/7/2019

… with sickle cell disease face a lifetime of unpredictable pain, hospitalizations and increased risk of stroke and premature death,” said Julie Kanter, M.D., University of Alabama at Birmingham. “It is so exciting to see the … the European Commission for the treatment of SCD. The U.S. Food and Drug Administration granted Orphan Drug status and Regenerative Medicine Advanced Therapy designation for LentiGlobin for the treatment of SCD. bluebird bio is conducting …

bluebird bio Presents New Data from Ongoing Phase 1/2 HGB-206 Study of LentiGlobin™ Gene Therapy for Sickle Cell Disease (SCD) at 61st ASH Annual Meeting and Exposition – Company Announcement - FT.com | Financial Times | 12/7/2019

… with sickle cell disease face a lifetime of unpredictable pain, hospitalizations and increased risk of stroke and premature death,” said Julie Kanter , M.D., University of Alabama at Birmingham . “It is so exciting to see the … the European Commission for the treatment of SCD. The U.S. Food and Drug Administration granted Orphan Drug status and Regenerative Medicine Advanced Therapy designation for LentiGlobin for the treatment of SCD. bluebird bio is conducting …

Rob Gronkowski

As more pro athletes use cannabis for aches and pain, the more they run afoul of rules - SFGate | 12/7/2019

… players. Among them are retired NHL players Riley Cote and Ryan VandenBussche; retired NFL players Steve Smith, Tiki Barber and Rob Gronkowski; retired NBA players John Salley, Kenyon Martin and Matt Barnes; Olympic hurdler Lolo … effects of CBD for pain, stress and other conditions. The Food and Drug Administration has approved the use of CBD to treat only a rare, severe form of epilepsy, but for no other uses so …

Framigham business to sell CBD edibles; FDA says ‘real risks’ tied to chemical | 11/29/2019

… A Bishop Street retailer has received a variance from the city to sell cannabidiol (CBD) edibles, even as the U.S. Food and Drug Administration declared that the chemical found in marijuana presents “real risks” in … and other products containing CBD. Former New England Patriots star Rob Gronkowski recently announced he’s teaming up with Patriots owner Bob Kraft and Abacus Health Products to promote a topical lotion containing CBD. The NFL …

Tim Stenzel

Stewardship / Resistance Scan for Dec 05, 2019 | 12/6/2019

… Scan for Dec 05, 2019 MRSA screening test OK’d Print & PDF FDA approves test that speeds MRSA screening The US Food and Drug Administration (FDA) today approved a new test to diagnose methicillin-resistant Staphylococcus … new regulatory classification that subsequent devices will be measured against. Tim Stenzel, PhD, MD, who directs the FDA’s Office of In Vitro Diagnostics and Radiological Health in its Center for Devices and Radiological Health, said …

Roche gets FDA marketing authorisation for cobas vivoDx MRSA diagnostic test | 12/6/2019

… illness in patients. Photo: courtesy of Arek Socha from Pixabay Roche Molecular Systems has secured marketing authorisation from the US Food and Drug Administration (FDA) for a new diagnostic test to detect Methicillin-resistant Staphylococcus … Health in vitro diagnostics and radiological health office director Dr Tim Stenzel said: “Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and …