With generic competition on the horizon for its older sleep disorder drug Xyrem, Jazz Pharmaceuticals plc gained an added indication for its GABA B receptor agonist Xywav as the FDA approved it for idiopathic hypersomnia. Read More
Reiterating prescription drug pricing provisions included in an executive order issued in July, U.S. President Joe Biden provided a bit of context and a little more detail about what he has in mind during a brief Aug. 12 speech on how his “Build Back Better” agenda would lower drug prices. Part of that agenda is to allow Medicare to directly negotiate prescription drug prices. “The only thing Medicare is not allowed to negotiate are prices for prescription drugs. My plan gets rid of that prohibition,” Biden said, adding that Medicare negotiates every other health care cost. Read More
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. Read More
Finding a functional cure to HIV is one of the biggest challenges in modern medicine, a task made so much tougher because of the virus’s ability to incorporate itself permanently into a host’s genome. But Diaccurate SAB, of Paris, thinks it may have a solution – and it’s all down to a discovery showing that the virus seems to make crucial immune CD4 cells go “bumpy”, lose their function and die. Read More
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. Read More
Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote. Read More
China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said. Read More
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antheia, Artiva, Atai, GC Labcell, Ginkgo, Introspect, Johnson & Johnson, Nimbus, Nobelpharma, Novartis, Novozymes, Noxopharm, Probiogen, Revixia, Schrödinger, Sunshine, Vyne, WHO. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, C4, Cipla, Coherus, Eisai, GC Pharma, Junshi, Merck, Nuvo, Nova, Pfizer, Vivet. Read More
