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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
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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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Read our takes on the biggest stories happening in the industry.
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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Contineum Therapeutics joined the 2024 initial public offering class on Friday with an SEC filing. The biotech will use the IPO proceeds to complete a Phase II trial for its most mature candidate targeting multiple sclerosis.
With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.
By votes of 11-0 and 8-3, respectively, an FDA advisory committee Friday deemed the risks of early death for both Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abecma acceptable.
Asgard Therapeutics, a Swedish gene therapy biotech, has closed a $32 million Series A round with help from prominent pharma players as it prepares for a 2026 IND.
Bayer will co-create a novel target identification platform that leverages Aignostics’ artificial intelligence technology and proprietary multimodal patient cohorts.
The Chinese biotechs are broadening their collaboration. Hansoh Pharma is licensing Biotheus’ anti-EGFR/cMet bispecific antibody to develop antibody-drug conjugates.
After forging a partnership last year, Astellas is ending the pact with Cartesian Therapeutics and stopping the development of a Pompe disease candidate.
The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.