News
Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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NeuBase announced a strategic restructuring, diverting resources from its Huntington’s program and shedding 60% of its workforce.
SURGE Therapeutics announced $26 million in Series A financing to address surgery-induced immune suppression and prevent post-surgical cancer recurrence and metastasis.
After suffering a blow to its multi-billion dollar liver cancer program, BridgeBio presented early but promising data in ultra-rare Canavan disease.
France-based biotech Mablink secured $30 million (€31 million EUR) to develop next-generation antibody-drug conjugates for the treatment of cancer.
Novartis, GlaxoSmithKline and Sanofi have announced plans for significant cutbacks and changes in their labor force overseas for financial, operational and logistical reasons.
Enliven Therapeutics and Imara will merge in an all-stock deal to form a precision oncology company. The new entity will operate under the name Enliven Therapeutics.
Matchpoint Therapeutics hit the ground running Friday with $100 million in investments and a focus on developing precision small molecule medicines.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Verseon has acquired Edammo, an artificial intelligence-focused company, to deepen its own AI-based drug discovery platform. Financial terms were not disclosed.