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Merck and Kelun-Biotech’s antibody-drug conjugate significantly improved progression-free and overall survival in a pivotal endometrial cancer study, though the companies have yet to specify when they plan to file for 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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Alkermes is exploring the potential spin-out of its cancer business into an independent, publicly traded company. Alkermes offered further details during an investor call Wednesday.
San Diego-based Arcturus Therapeutics signed a strategic collaboration and licensing deal with CSL Seqirus to help develop and commercialize vaccines.
Q1 is the time when many employers are actively recruiting new talent. Because it takes an average of 60 days to fill a job opening, Q4 might be the best time to apply for jobs in the life sciences.
Flush with cash from the growing success of its chemotherapy drug, Exelixis dropped $100M on two collaboration deals this week to invest in promising early clinical assets.
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
A Data Safety Monitoring Board overseeing the Phase Ib/II trial assessing UniQure’s gene therapy for Huntington’s disease recommended that enrollment in the higher-dose cohort could resume.
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.
Surface Oncology announced it is pausing the development of its CD39-targeted antibody SRF617 and cutting around 20% of its workforce to focus on its lead anti-IL-27 program SRF388.
J.P. Morgan launched its new life science-focused private equity team, Life Sciences Private Capital, to support early- and growth stage biotech companies.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.