Drug Development
Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027.
FEATURED STORIES
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
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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Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant to support commercial production.
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
Coherus is narrowing its pipeline projects while Gyre reorganizes after an acquisition, with both biotechs conducting workforce reductions.
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.
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.