FDA Advisory Committee Reviews Pfizer/BioNTech Covid-19 Vaccine

Pfizer and BioNTech submitted their Covid-19 vaccine to the FDA on November 20, and after reviewing the data for 19 days, the FDA convened a virtual advisory committee meeting to get their input. The advisory committee voted 17-4 to recommend approval for use in people age ≥16. Here are the details of that meeting.

FDA Approves Pfizer/BioNTech Covid-19 Vaccine

The FDA issued an emergency use authorization for the first SARS-CoV-2 vaccine in the U.S., and the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended use and also made recommendations on who should get it first. Here are the details, along with a peek at the issues that European regulators are considering relating to this and other Covid-19 vaccines.

ObesityWeek

Three innovative drugs all had positive weight loss data at ObesityWeek. A once-weekly formulation of Rhythm Pharmaceuticals’ Imcivree (setmelanotide), a once-daily injectable MC4 agonist; Novo Nordisk’s Ozempic (daily injectable semaglutide), a diabetes drug; and Novo Nordisk’s AM-833.

PREVIEW: FDA Review of Pfizer/BioNTech Covid-19 Vaccine

The FDA staff has been reviewing the data on Pfizer and BioNTech’s BNT-162b2, a Covid-19 vaccine, since November 20, 2020, and the conclusion was that it is safe and effective. On December 10, an FDA advisory committee will review the data and make their recommendation. Here is a summary of the data and the issues.

Coronavirus Update 12/02/2020

The first coronavirus vaccine – outside of Russia and China – has been approved. It is also the first mRNA vaccine ever approved for anything. The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Pfizer and BioNTech’s BNT-162b2, an mRNA vaccine, and the first patients should be inoculated in the U.K. in “a few days.” The CDC\'s Advisory Committee on Immunization Practices voted to recommend that healthcare personnel and residents of long-term care facilities get the first doses, which could be available in the U.S. in mid-December. Operation Warp Speed officials also discussed how the vaccines will be distributed around the country.

Neuroendocrine Tumor Update

As the treatment of neuroendocrine tumors evolves, scientists are developing targeted therapeutics to attack these cancers. At the NANETS virtual meeting, researchers reported positive data on a radiotherapeutic, called for more adjuvant treatment studies, uncertainty over the value of next-generation sequencing for NET, and some promising treatments.

Who Should Get the Covid-19 Vaccine First?

Now that a Covid-19 vaccine is close to a reality, the question is who should get vaccinated first. The answer depends on who you ask and whether you want to save the most lives or take the most “ethical” approach. The CDC’s Advisory Committee on Immunization Practices tackled this issue at their most recent meeting, and the conclusion was: prioritize healthcare workers over the elderly because it is more “equitable,” even though it doesn’t save nearly as many lives.

FDA Advisory Committee Rejects Alzheimer's Drug

An FDA advisory committee rejected Biogen and Eisai’s aducanumab to treat Alzheimer’s disease, disagreeing with the FDA on the data. The FDA tried to convince the panel that a failed trial, with a positive post hoc subgroup analysis, is sufficient for approval, but the panel was not buying that argument. The FDA is expected to make a decision by March 7, 2021. This is a very detailed synposis of the virtual meeting.

FDA Advisory Committee on Alzheimer's Disease Drug -- Preview

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting virtually on November 6, 2020, to discuss the biologics license application for Biogen and Eisai’s aducanumab, an intravenous treatment to delay clinical decline in patients with Alzheimer’s disease (AD). The FDA reviewers were surprisingly positive about aducanumab, but the FDA staff were not all on the same positive page. So, it should be an interesting meeting.

Dry AMD Therapeutic Development Summit

After some very disappointing trials in dry AMD and GA, retina specialists are hoping that one or more of the treatments currently in development – complement inhibitors or cell therapies – will be successful, but there are questions about regulatory issues, trial endpoints, lack of validated biomarkers, the meaningfulness of efficacy levels being achieved, efficacy in Asian patients, long-term compliance, insurance coverage, and more.

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