The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc.
Pfizer Inc.’s voluntary recall of batches of Chantix (varenicline) in mid-July called attention to the smoking-cessation market, where the nicotinic acetylcholine receptor agonist holds lead position, with Glaxosmithkline plc’s Zyban (bupropion) – another oral prescription drug – also a contender. In line to potentially shake up the space with cytisinicline, a plant-based alkaloid, is Achieve Life Sciences Inc.
According to the White House, the FDA is poised to allow COVID-19 booster shots from Pfizer Inc. and Moderna Inc., the two mRNA vaccines, but only for those people with compromised immune systems. The FDA announcement was anticipated to be as early as today, Aug. 12, and the boosters could be available as quickly as this coming weekend.
LONDON – Stopping people under 40 from receiving Astrazeneca plc’s COVID-19 vaccine has put an end to the serious blood-clotting syndrome associated with the product, with no new cases in the U.K. for the past four weeks, according to an expert panel of hematologists.
LONDON – Mission Therapeutics Ltd. has honed down a collection of 100-odd deubiquitylating (DUB) enzymes, to identify two that degrade misfolded proteins in Parkinson’s and Alzheimer’s diseases, triggering a $20 million milestone from partner Abbvie Inc.
The U.K.’s Competition and Markets Authority (CMA) has accused Pfizer Inc., together with a smaller U.K. player, of illegally overcharging the National Health Service (NHS) for the anti-epilepsy drug branded Epanutin (phenytoin sodium) before it went off patent in 2012.
New top-line results from the phase IIb/III Allegro trial of Pfizer Inc.'s once-daily oral JAK3 inhibitor, ritlecitinib, have met the trial's primary efficacy endpoint of improving scalp hair regrowth in patients with alopecia areata vs. placebo. The new data, to be paired with long-term trial results from Pfizer's long-term Allegro-LT study, move the program one step closer to an expected early 2022 NDA filing.
LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
