Policy
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
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FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
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The House Select Committee asks the FBI for a briefing on GenScript’s links to China, fueling the challenge facing public relations and investor relations teams at US biopharma firms and Chinese CDMOs.
Given their seven-figure price tags, it’s not clear how accessible the would-be cures will be to U.S. patients on public or private insurance.
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.
Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.
The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity.
An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials.
Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq.