Drug Development
Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.
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If we guard our secrets, patients suffer. Only through a commitment to transparency and data sharing—and artificial intelligence—can we make cell and gene therapies safer and more effective.
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.
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EyePoint’s quest to reduce treatment burden for patients with age-related macular degeneration has hit a bump in the road, with a clinical miss driving the biotech’s stock down by 70%.
Ivonescimab notched its third approval in China last week, but the label update has tempered expectations for the Summit Therapeutics/Akeso drug, showing that progression-free survival declines over time.
AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma.
Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month, showed “impressive” stabilization, analysts say.
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.
Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.
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.
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.
It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.
After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.