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The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
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DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.
After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company’s driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.
Ibogaine’s unconventional “matrix pharmacology” may underlie both its therapeutic promise and unpredictable cardiac risks. Unraveling this mechanism could help drug developers hoping to bring ibogaine analogs to market.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
As biotechs faced investors at the J.P. Morgan Healthcare Conference this week, they emphasized agreement with the FDA on clinical trial design and regulatory pathways to approval. Atara, meanwhile, lamented the agency’s “complete reversal of position” after its therapy for a rare surgical complication was rejected.
After J.P. Morgan, biotech’s bold promises meet real-world challenges. In 2026, success starts with a CDMO partner who accelerates timelines and anticipates every manufacturing hurdle. Learn how AGC Biologics offers tailored cell line solutions for complex molecules.
Less than six months after cutting 20% of its employees, Vedanta Biosciences has again laid off staff. According to one affected staffer, half of the Cambridge, Massachusetts–based biotech’s workforce is being cut while most of the rest are furloughed.
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
Ocular Therapeutix’s lead asset is Axpaxli, being developed for wet age-related macular degeneration. A Phase III study is underway, with data expected this quarter.
Speaking on the sidelines of the J.P. Morgan Healthcare Conference, Novo business development executive Tamara Darsow said the company is gunning for obesity and diabetes assets.
The Novo Nordisk Foundation’s funds will go toward supporting early-stage companies working in “human health, planetary health and societal resilience.”
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
After a cacophony of troubles hit the RNA editing biotech last fall, CEO Ram Aiyar is in San Francisco to develop partnerships, pitch the potential of its new AATD program and find more money to keep the dream alive.