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An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Almost three months to the day after an FDA advisory committee overwhelmingly rejected Alkermes’ major depressive disorder treatment, ALKS-5461, the company received word that the regulatory agency will not approve the medication.
Although bioterrorism doesn’t get the kind of attention more traditional bombings and shootings receive, the biotech industry and the federal government are paying attention and actively funding and developing countermeasures to potential bioterror, military and public health emergencies.
Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
You have to give San Diego-based Gossamer Bio credit for the way it’s adapted its plans for an initial public offering (IPO) to deal with the government shutdown.
Four months after getting the green light in the U.K. for treatment of children with acute lymphoblastic leukemia (ALL), Novartis’ CAR-T treatment Kymriah, known as Tisagenlecleucel in the U.K., has gained approval for treatment of adults with diffuse large B-cell lymphoma (DLBCL).
Recently, in the U.S., there has been a shortage of an anti-anxiety drug, buspirone. The American Society of Health-System Pharmacists (ASHP) lists shortages, and as of Jan. 31, 2019, noted shortages of buspirone tablets manufactured by Accord Healthcare, Mylan and Teva Pharmaceutical.
Shares of AVEO Oncology plunged 45 percent Thursday trading after the Cambridge, Mass.-based company said it accepted the recommendation of the U.S. Food and Drug Administration to not seek regulatory approval of its kidney cancer drug, Tivozanib at this time.
The plan is aimed at providing new transparency to the prescription drug market and removing the veil of hidden rebates conducted between companies and pharmacy benefits managers.
MorphoSys AG announced today that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute.
Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.