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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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Johnson & Johnson announced it was acquiring all outstanding shares of Abiomed for $16.6 billion to expand Abiomed’s cardiovascular technologies and increase patient access.
In a Phase III trial, Pfizer’s RSVpreF, a bivalent RSV vaccine, protected infants against severe medically attended lower respiratory tract illness when administered during the second or third trimester.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.
The implications of the Inflation Reduction Act of 2022 (IRA) are beginning to show as Alnylam drops the Stargardt indication for vutrisiran and Sanofi’s CEO reassures investors.
ESSA confirmed that Janssen has stepped away from a prostate cancer collaboration due to “operational recruitment challenges.”
Platform technology company Replay, based in San Diego and London, has launched Eudora, a gene therapy company targeting genetic diseases of the retina.
CytoDyn withdrew its pending Biologics License Application for leronlimab in HIV, citing concerns involving the contract research organization managing its trials.
While reporting stellar third-quarter financials, AbbVie announced it was halting development of cedirogant and provided updates on Skyrizi, Rinvoq and Humira.
An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzhiemer’s drug, lecanemab, is attributing a patient’s death to the treatment.