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FDA Advisory Committee Recommends EUA for J&J Covid-19 Vaccine

An FDA Advisory Committee voted unanimously to recommend the FDA issue an emergency use authorization (EUA) for Johnson & Johnson’s one-dose Covid-19 vaccine. While the vaccine doesn’t look quite as efficacious in seniors, the panel agreed it is safe and effective. The acting panel chair summed it up: “In this environment, whatever [vaccine] you can get, get.”

Preview of FDA Panel Review of J&J Covid-19 Vaccine

An FDA advisory committee will review a third Covid-19 vaccine on February 26, Johnson & Johnson/Janssen’s Ad26.COV2.S. The panel is likely to recommend approval, but there are several questions about the vaccine that should make for an interesting discussion.

World Conference on Lung Cancer

What happens to lung cancer patients when osimertinib doesn’t work or stops working? There are next-generation EGFR inhibitors in development that target the multiple mutations that allow cancers to evade osimertinib. Here is a look at three: Spectrum Pharmaceuticals’ poziotinib, Johnson & Johnson’s amivantamab, and Takeda’s mobocertinib (TAK-788) – plus new data on AstraZeneca’s Tagrisso (osimertinib).

Bascom Palmer Eye Institute's Angiogenesis, Exudation, and Degeneration 2021

Drug development for age-related eye diseases is an active area, and it is not just a race among me-too agents – at least not among the drugs reviewed at this meeting. Among five drugs in development to treat geographic atrophy, there were four different approaches reviewed. Among five drugs in development to treat wet age-related macular degeneration, there were four new agents and one new delivery method. On top of that, three gene therapies were discussed.

Coronavirus Update 02-03-2021

There is so much Covid-19 news flying around that it can be difficult to keep up. Here, in addition to the latest numbers, we pull together the latest key news in an organized and easy-to-read way, and we put them in perspective. There are likely some surprises in here, particularly about the virus variants and about who is dying.

ASCO-GI

Here we report on three of the promising drugs in early development that were discussed at ASCO-GI and are wroth watching: Five Prime Therapeutics’ bemarituzumab for gastric cancer, Zymeworks’ zanidatamab in gastroesophageal adenocarcinomas , and Tyme Technologies’ SM-88 for pancreatic cancer.

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.