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Capricor Therapeutics’ CEO Linda Marbán believes the FDA is willing to work with the biotech as the Aug. 22 deadline approaches for its Duchenne muscular dystrophy cell therapy deramiocel, with the biotech’s stock climbing 68% on the update.
Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market.
AI is quickly becoming a central force in drug development, from powering pharma engines to permanently rewiring the capital markets.
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Johnson & Johnson secured rights to prizlon-cel in 2023 for $245 million upfront. The asset in June last year showed a 100% response rate as a second-line option in a Phase 1b study for 10 patients with relapsed or refractory large B cell lymphoma.
Despite ranking among the world’s top scientific producers, Italy has struggled to turn research into startups. Now, stronger tech transfer offices, private capital and returning scientists are pushing the country toward a more mature innovation economy.
Sponsors of the pivotal study behind Amgen’s rare disease drug Tavneos saw unblinded findings for the drug and re-adjudicated data from nine patients to make the drug seem effective, according to European regulators.
Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.
The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts.
PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms.
Last month, biopharmas cutting or planning to cut their workforces included Amgen, GSK and Novartis, with Novartis’ layoffs affecting the most people.
Avalyn Pharma and Generate Biomedicines executives discuss the long hours, hard work and rewarding moments of taking their companies public.
Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for the Prader-Willi syndrome community.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.