Food and Drug Administration

Selected news for the healthcare topic - Food and Drug Administration, collected since 10/2017. This healthcare topic shares news with COVID-19, Pfizer, COVID-19 Vaccine, Coronavirus, Moderna and hundreds of others.

Please provide a valid email address.

Selected Headlines

Date Headline (link) Source Relevant Snippet
1/13/2022 Medicare Proposes to Restrict Coverage of Controversial and Costly Alzheimer's Drug Yahoo News ... applies to similar drugs in development.The preliminary proposal by the Centers for Medicare and Medicaid Services (CMS) is highly unusual. “CMS almost never demands such trials for a drug already approved by the Food and Drug Administration ,” The Washington Post’s Laurie McGinley and Amy Goldstein note .Dr. Lee Fleisher, the chief medical officer and director of the Center for Clinical Standards and Quality at CMS, said in ...
1/13/2022 Insurers applaud CMS' proposal for Medicare to only cover Aduhelm for seniors in clinical trials | FierceHealthcare FierceHealthcare ... analyzing more data on Aduhelm will provide much-needed insights into the drug’s safety and effectiveness,” said Adam Myers, M.D., senior vice president and chief clinical transformation officer for the association.The Food and Drug Administration granted accelerated approval in June 2021 to Biogen’s Aduhelm to target beta amyloid plaques in the brain, despite objections from agency advisers over its effectiveness. But there has been a major ...
1/12/2022 Medtronic to acquire Affera, a cardiac arrhythmia technology firm, for $925 million – Minneapolis Star Tribune tech4mag.com ... cardiac arrhythmias, for $925 million.While Medtronic declined Monday to share the sale price, analysts at Piper Sandler disclosed terms of the deal, which includes $250 million that’s contingent upon Affera receiving U.S. Food and Drug Administration approval for its nascent technology.Boston area-based Affera makes cardiac mapping and navigation systems and catheter-based cardiac ablation technologies.Medtronic, which has its operational headquarters in Fridley, already holds a ...
1/12/2022 Drug Safety Associate II – Iovance Biotherapeutics Inc – San Carlos, CA medacura.com ... Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures. Ensures compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country, and regional regulations for the reporting of adverse events to regulatory agencies.Specific Responsibilities:Works on problems of diverse scope where analysis of data requires evaluation of ...
1/12/2022 Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection | OPA | Department of Justice justice.gov ... hired to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children. As part of her plea agreement, Torres admitted that she knowingly lied to a U.S. Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection concerning the firm. Specifically, Torres admitted that she falsely portrayed the clinical trial as having been conducted legitimately and honestly, when in fact Torres knew ...
1/12/2022 TherapeuticsMD Inc. [TXMD] is 1.97% higher this YTD. Is it still time to buy? dbtnews.com TherapeuticsMD Inc. [NASDAQ: TXMD] price plunged by -0.96 percent to reach at -$0.01. The company report on December 10, 2021 that U.S. Food and Drug Administration (FDA) Responds to Request From TherapeuticsMD to Revise Certain Manufacturing Testing Limits for ANNOVERA®.– FDA determined that it could not approve proposed revisions to the manufacturing testing limits requested through the Supplemental New Drug Application (sNDA) — FDA provided recommendations and requested ...
1/12/2022 Josie's Organics prepackaged baby spinach E. coli Outbreak over after 15 sick in 10 states foodpoisonjournal.com CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) investigated a multistate outbreak of E. coli O157:H7 infections.Epidemiologic and laboratory data showed that Josie’s Organics prepackaged baby spinach with a “best by” date of October 23, 2021, made people sick.As of January 6, 2022, this outbreak is over.A total of 15 people infected with the outbreak ...
1/12/2022 Sen. Marco Rubio demands FDA change guidance prioritizing race in administering COVID drugs washingtonnewspost.com NEW You can now listen to Fox News articles!FIRST ON FOX : Sen. Marco Rubio, R-Fla., sent a letter to the acting commissioner of the Food and Drug Administration on Tuesday demanding that the agency immediately update its guidance so that patients seeking monoclonal antibody treatments will be prioritized based on their medical history and not their race or ethnicity.Rubio’s letter comes in response to a fact ...
1/12/2022 Experts claim that the benefits of the Molnupiravir drug outweigh the risks; it might be prescribed for emergency use. - Samachar Live samacharlive.com ... the medicine had severe health safety issues. According to them, there have been no compelling negative effects on people thus far.Developed by US-based drug company Merck, Molnupiravir is approved by the US Food and Drug Administration against COVID-19. It is supported by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults with a high risk of ...
1/12/2022 Lowry: The idiocy of vaccine mandates for kids Boston Herald The old legal maxim is that everything which is not forbidden is permitted. Many public-health experts apparently have their own version of this rule — whatever is not forbidden must be mandated.It was less than three months ago that the Food and Drug Administration approved the COVID-19 vaccine for children on an emergency basis, and already there are debates whether schools should mandate it and jurisdictions prohibit ...
1/12/2022 Covid-19 Pill Developer to Spend SPAC IPO Funds on Clinical Trial, Hiring - WSJ The Wall Street Journal ... others.Pardes is one of several drugmakers —alongside Pfizer Inc., Watertown, Mass.-based Enanta Pharmaceuticals Inc. and Japanese drugmaker Shionogi & Co. Ltd.––that are developing oral antiviral pills against Covid-19. The U.S. Food and Drug Administration last month cleared Pfizer’s Covid-19 pill for use , making it the first drug that newly infected patients can take to treat the disease at home.Newsletter Sign-up WSJ CFO ...
1/12/2022 Cotton Demands Answers from FDA About Using Race to Determine Covid Treatment Eligibility US Senate FOR IMMEDIATE RELEASEContact: James Arnold or Mary Collins Atkinson (202) 224-2353January 12, 2022Cotton Demands Answers from FDA About Using Race to Determine Covid Treatment EligibilityWashington, D.C. — Senator Tom Cotton (R-Arkansas) sent a letter to the U.S. Food and Drug Administration (FDA) demanding answers about reports that the FDA is suggesting race should be used to determine eligibility for the monoclonal antibody treatment Sotrovimab.In ...
1/12/2022 Medicare considers covering cost of Aduhelm for clinical trial participants only McKnight's Long Term Care News Medicare may cover the high cost of treatment with the Alzheimer’s drug Aduhelm only for highly qualified participants in approved clinical trials, the Centers for Medicare & Medicaid Services announced Tuesday.The unusual move is tied to Aduhelm’s Food and Drug Administration approval under an accelerated process, but appropriate for the Medicare population, CMS officials said in a press briefing.Aduhelm is a monoclonal antibody that is recommended for ...
1/12/2022 Senate committee skewers CDC's ‘confusing’ pandemic communications McKnight's Long Term Care News ... noted delays in promised testing supplies, conflicting mask and booster messaging and uncertainty about whether testing was needed after isolation and quarantine, among many other issues.Officials pushed back. The acting head of the Food and Drug Administration agreed that her agency had experienced challenges during the pandemic but that the focus should be on handling surging omicron variant case, according to a report by Reuters.“I think it’s ...
1/12/2022 Why Biogen Stock Is Sinking Today | Nasdaq Nasdaq ... in serious jeopardy. The steep sell-off for the biotech stock reflects this more-negative outlook.Image source: Getty Images.So why didn't CMS opt to provide more extensive coverage for Aduhelm, which won Food and Drug Administration (FDA) accelerated approval in 2020? CMS Administrator Chiquita Brooks-LaSure said in a press release, "CMS has proposed an evidence-based coverage policy after experts reviewed all relevant available evidence and feedback ...
1/12/2022 Biogen hits Medicare wall | Nasdaq Nasdaq ... Alzheimer’s treatment is a Trojan horse that presages more sweeping limits on medical spending. But the decision is unlikely to be a precedent given how much is exceptional in this story.The U.S. Food and Drug Administration ’s approval of the drug in June went against an advisory panel that concluded there was insufficient evidence of its efficacy. A U.S. government watchdog said in August it would review the ...
1/12/2022 Here's where and when you can find the COVID vaccine for 5- to 11-year-olds in the Appleton, Oshkosh areas postcrescent.com Here's where and when you can find the COVID vaccine for 5- to 11-year-olds in the Appleton, Oshkosh areasMadeline Heim]Months after COVID-19 vaccines were approved for adults and teens, younger children are now eligible for the shot.The federal Food and Drug Administration [OK'd Pfizer's kid-size vaccine dose — about ...
1/12/2022 Why Biogen's Medicare mess is bad for the pharmaceutical industry - STAT STAT ... Biogen’s embattled Aduhelm only in clinical trials could have a simple but difficult result for the pharmaceutical industry: chaos.The draft decision released yesterday is a response to the June choice by the Food and Drug Administration to grant the medicine an accelerated approval, going against a committee of the FDA’s expert advisers. That sets up an unusual dynamic: Generally, Medicare, the government’s health benefit for people ...
1/12/2022 Puma Biotechnology's NERLYNX® Included in Two Important NCCN Clinical Practice Guideline Updates for the Treatment of Breast Cancer Yahoo News ... approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L). This update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.Joyce O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas ...
1/12/2022 Puma Biotechnology's NERLYNX® Included in Two Important NCCN Clinical Practice Guideline Updates for the Treatment of Breast Cancer | Business Wire Business Wire ... approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L). This update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.Joyce O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas ...