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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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The initial public offering on the Nasdaq is a last-ditch effort by the biotech as there is “substantial doubt” as to the company’s “ability to continue as a going concern” without the IPO, according to its SEC filing.
Data from a Phase II trial showed that Adcetris, used in a combination approach, is effective in early-stage classical Hodgkin lymphoma patients.
Valneva’s chikungunya vaccine candidate VLA1553 showed that the shot safely and rapidly induced high rates of seroprotection. Merck earlier in 2023 discontinued its chikungunya program.
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.
The company announced Monday its shareholders elected Susan Langer, current president of Souffle Therapeutics, to its board of directors, replacing her reputed romantic partner Alex Denner.
After multiple delays, the contract manufacturer presents its earnings report for the third quarter of fiscal 2023, bumping its stock by more than 10%.
Scott Rivers, president and managing partner of an executive search and talent branding firm, weighs in on what managers can do to keep top talent.
In its latest legal challenge to the Inflation Reduction Act, the U.S. Chamber of Commerce has appealed to a federal court to stop drug price negotiations until ongoing litigation plays out.
The company is paying $3.2 billion upfront in cash for Chinook’s two immunoglobulin A nephropathy candidates, atrasentan and zigakibart, which will complement its own IgAN hopeful iptacopan.
More than 3,000 state and local governments will receive nearly $19 billion in payments from drugmakers and pharmacy chains in the most recent round of opioid settlements.