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Coronavirus Update 01/19/2021

Summary: Here is an update on testing, treatment, and vaccines, with some interesting color on the difficulties of getting a vaccine.

SERDs -- An Advance for Advanced Breast Cancer

The San Antonio Breast Cancer Symposium offered a peek at seven selective estrogen receptor degraders in development to treat advanced ER+/HER2-negative breast cancer. This report offers details on each of them: AstraZeneca’s AZD-9833, G1 Therapeutics’ rintodestrant, Lilly’s LY-3484356, Olema Oncology’s OP-1250, Roche/Genentech’s giredestrant (GDC-9545), Sanofi’s amcenestrant, and Zentalis Pharmaceuticals’ ZN-c5.

ACIP on Moderna Vaccine and Prioritizations

The FDA issued an emergency use authorization for the second SARS-CoV-2 vaccine in the U.S., Moderna’s mRNA-1273, and the CDC’s Advisory Committee on Immunization Practices (ACIP) called an emergency meeting and recommended its use. The panel also identified the people who will be eligible for either vaccine in Phases 1b and 1c. A perspective at the end looks at the situation in California, and it could change your thinking on prioritization.

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.