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Awaiting a decision on Nov. 22 for its embattled Duchenne muscular dystrophy cell therapy deramiocel, Capricor has reduced its workforce by 10% and slowed programs not directly related to deramiocel, the biotech revealed in its third quarter earnings report.
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Policy uncertainty is hampering the growth of U.S. biotech as China rises thanks to carefully planned investment in the industry, experts said during a BioSpace webinar.
Last month, the FDA committed to designing a “fit-for-purpose” framework for regulating rare disease therapies based on patient need and realistically attainable evidence. With the upcoming decision for Capricor’s Duchenne muscular dystrophy cell therapy deramiocel, this paradigm faces its first key test.
After emraclidine’s schizophrenia fail and Cobenfy’s laggard launch, it’s too early to know who made the better buy: AbbVie, in its $8.7 billion Cerevel takeover in late 2023, or Bristol Myers Squibb, which spent $14 billion for Karuna just two weeks later.
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Watching the baseball playoffs this week, I was struck by the parallels between the Los Angeles Dodgers and Eli Lilly. Both franchises spend a lot of money and always appear to come out on top.
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The seven proposals in the Bio Advance plan include easing clinical trial starts, boosting manufacturing and establishing a new White House office to coordinate the government’s biotech policy.
Beam Therapeutics’ risto-cel provided at least 12 consecutive months of freedom from severe pain crises for patients with sickle cell disease in a mid-stage trial, setting the stage for an FDA application as early as this year.
Bayer’s Sunharbo has secured the first FDA approval of its class, establishing a regulatory pathway for other factor XIa inhibitors, such as Bristol Myers Squibb and Johnson and Johnson’s milvexian.
The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.
Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
The Phase 3 results help clarify the safety profile of Zealand and Boehringer Ingelheim’s survodutide, but analysts do not think the drug will find utility beyond patients with liver-related risk factors.
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
Vir Biotechnology is targeting a mid-2027 regulatory submission for its monthly chronic hepatitis delta regimen, with head-to-head data against Gilead’s Hepcludex expected next quarter.
Compass Pathways has completed an FDA filing for COMP360, with an expected launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression last Monday.