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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FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Pfizer and Flynn Pharma are under the scrutiny of British watchdogs once again, after officials said the companies have been overcharging for an anti-epilepsy medication in the U.K. for over four years.
The whistleblower claim was brought by former employee Michael Bawduniak, who accused the company of paying off doctors to favor its multiple sclerosis drugs over those of its competitors.
Sandoz hopes its high-concentration formulation of an already greenlit biosimilar will be approved by the time AbbVie’s blockbuster drug Humira loses patent protection in the United States.
The LPN technology used in the mRNA COVID-19 vaccines has been the target of numerous patent challenges. Here’s a look at recent biopharma patent disputes.
Avadel and Jazz Pharma, a leader in treating sleep disorders, are locked in a patent dispute. If it receives final FDA approval, Avadel’s Lumryz could challenge Jazz’s market dominance.
In what it is calling a strategic decision, Sesen Bio announced Monday that it has paused development activities of Vicineum, its lead asset, in the United States.
Mid-July is a relatively quiet time for the FDA in terms of drug approvals, but Incyte and Arcutis will have all eyes on the regulator as they await decisions in vitiligo and psoriasis.
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.