STAT+: Pharmalittle: Pfizer seeks full FDA approval for its Covid-19 vaccine; CT attorney general calls some Sacklers ‘entitled thugs’
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because … sure enough … here we are again, staring down the laptop and sorting out the growing to-do list. But what can you do? The world keeps spinning — unless you subscribe to flat-earth conspiracies, among others. Well, that is a discussion best left for another day. Meanwhile, there is work to do. So here are a few items of interest to get you going. Hope you conquer the world and do keep in touch if something saucy emerges. …
Pfizer (PFE) and BioNTech (BNTX) said the Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said a decision is likely to come within two months, CNN tells us. The companies are seeking approval for the two-dose series for people age 16 and older, and expects to apply for approval for people ages 12 to 15 when the data are available. The agency considers this matter a priority.
The FDA will temporarily allow certain manufacturers to distribute generic versions of the anti-smoking drug varenicline with elevated levels of an impurity that may cause cancer. The agency is doing so in order to maintain availability after Pfizer halted global distribution of its Chantix brand-name drug last month. Agency scientists evaluated the risk of exposure at interim acceptable intake levels up to 185 mg per day and determined that it presents minimal additional cancer risk, according to an FDA statement.
Continue to STAT+ to read the full story…
