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.
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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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U.S. Senator Chuck Grassley (R-Iowa) set the tone early, mentioning his constituents rationing drugs because of high prices or “leaving their prescription on the pharmacy counter because it costs too much,” but acknowledging that innovations “take time and money.”
Roche’s Flatiron Health and the U.S. Food and Drug Administration’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement.
More news has come from China about the two babies born following He Jiankui’s experiment using CRISPR to make the children resistant to HIV while they were still embryos. Now, there is some evidence to suggest that the two infants could develop genetically-enhanced brains.
The FDA noted some concerns over the drug’s safety profile. Treatment with selinexor is associated with significant toxicity, the agency noted in its materials.
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
Two-year follow-up data shows 100 percent overall survival and 100 percent event free survival in comparison to a historical standard of care from a historical control group.
Court documents have shown how invested Richard Sackler was in the drive at Purdue Pharma to make OxyContin a success. A recent deposition that was unsealed has revealed just how far Sackler was willing to go.
The Florida-based company points to inaccuracies in the letter Sanders sent earlier this month regarding the price of LEMS treatment Firdapse.
AbbVie announced that they have received approval for an additional indication of HUMIRA, a fully human anti-TNF-alpha monoclonal antibody, for the treatment of hidradenitis suppurativa.
Seven pharma executives will enter the Congressional crucible next week as they face questions and concerns over the rising costs of prescription drugs.