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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As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
In the company’s FDA Law Blog, attorneys Deborah L. Livornese, JP Ellison and Josephine M. Torrente outlined problems with the FDA’s complete response letter (CRL) and what should be done about it.
The U.S. Food and Drug Administration (FDA) is eying the spring of 2019 to finalize its biopharmaceutical classification system-based biowaivers guidelines. On Thursday, the regulatory agency released the draft guidance for public consultation.
Growth in Asia continues with ongoing investment in Headquarters site
As part of a plan to lower prescription drug prices for millions of Americans, President Donald Trump is set to announce a sweeping plan to overhaul how Medicare pays for medication.
Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The new medication has a novel mechanism of action that, Roche said, inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate.
Lupin Neurosciences today announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla™ (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.
Bloomberg Businessweek published a deep-dive into the life of the Shermans and the issues surrounding their death. “No one knows who did it, or why, but everyone has a theory,” the article’s subhead reads.
The Senate passed the bill on October 3 in a 98 to 1 vote. The House passed its version a week earlier in a vote of 393 to 8. The legislation includes provisions to promote research into new pain management drugs and expands access to substance abuse treatment for Medicaid patients.
What do you wish someone would’ve told you at the beginning of your career? Most people reflect on their career development and think, ‘If only I knew then what I know now, I’d be farther along.’