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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In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks.
Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.
The Federal Trade Commission filed a lawsuit Tuesday seeking an injunction to prevent Amgen’s buyout of Horizon Therapeutics, which the agency says would “entrench monopoly drugs.”
The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.
As insulin prices skyrocket, pharmas and PBMs faced pointed critique from the Senate HELP Committee, led by Sen. Bernie Sanders (I-VT).