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With a Phase 3 trial reducing serious and severe hypoglycemic episodes following weight loss surgery, Amylyx Pharmaceuticals plans to file for approval this year. If granted market entry, avexitide could hit peak sales of $1.7 billion worldwide, analysts estimate.
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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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Read our takes on the biggest stories happening in the industry.
The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
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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.
The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter.
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.
In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life sciences ecosystem has evolved over the last decade—from stronger tech transfer and growing venture capital to the gaps that still keep it from matching the UK, Germany or France in company creation and scale.
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.