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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CytoDyn Inc. has tapped Cyrus Arman as its new president and he is expected to take over the reins of the company as chief executive officer and be added to the board of directors within six months.
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
Gossamer Bio sold shares of its common stock to pave its runway through mid-2024 while Teva and AbbVie reach deals in opioid settlements.
BioSpace takes a look at some of the recent legal battles and settlements related to the opioid epidemic across the industry.
Aldeyra Therapeutics announced results from a crossover clinical trial, showing that its drug candidate reproxalap was effective in improving ocular redness and tear production in patients with dry eye disease.
Exelixis’ Cabometyx, in combination with two BMS-owned drugs, hit the primary endpoint of progression-free survival but missed the secondary endpoint of overall survival in renal cell carcinoma.
Vertex Pharmaceuticals plans to acquire ViaCyte for $320 million in cash. ViaCyte focuses on stem cell-derived cell replacement therapies that they hope will cure type 1 diabetes (T1D).
HRA Pharma, a Perrigo company, has submitted an application to the FDA seeking approval for the country’s first-ever over-the-counter (OTC) birth control pill.
Sanofi announced positive data for its therapeutic, fitusiran, for treating patients with hemophilia A and B, as well as efanesoctocog alfa therapy for treating hemophilia A.
Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.