Policy
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.
FEATURED STORIES
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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Netherlands-based Pharming Group NV has denied any involvement in a potential theft of intellectual property belonging to CSL Behring from Joseph Chiao, who recently joined Pharming as medical director.
Citing “sources familiar with the matter,” The Wall Street Journal reported that the agreement, should it be reached, would ultimately settle the matter for the company related to sales of Duragesic and Nucynta.
Pharming categorically denies having had any involvement in the alleged abstraction of proprietary information by Dr Joseph Chiao from his former employer CSL
Frank Reynolds, chief executive officer of PixarBio, made outlandish claims to investors and even compared himself to Apple’s Steve Jobs and Jesus Christ. Those were the claims of a witness made on the witness stand in an ongoing securities fraud trial.
AmerisourceBergen, McKesson and Cardinal Health are in the midst of negotiations for a multi-billion settlement over litigation filed against each of the companies for their role in distributing opioid drugs across the country.
Potential approval would validate the use of Algenex’ CrisBio® technology for the manufacture of recombinant subunit vaccines
Biocair, a global leader in specialist logistics, announced that its Frankfurt office has joined the company’s network of ISO 9001:2015 certified operations.
Alzheimer’s Research UK has responded to an announcement that could see new legislation aimed at providing faster access to medicines.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has granted Fast Track designation to T-Guard, Xenikos’ flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
The patch is a once-per-day treatment that provides sustained concentrations of Secuado (asenapine), an atypical antipsychotic drug used to treat schizophrenia.