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BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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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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The executive shuffle continues across the biopharma industry as companies shore up leadership needs with these Movers & Shakers.
Cassava filed a lawsuit in federal court against individuals linked to a Citizen’s Petition filed with the FDA that raised concerns about data manipulation in a clinical study of simufilam.
Genentech made approximately 35 presentations at ECTRIMS involving blockbuster MS drug Ocrevus drug, with a focus on relapsing-remitting MS and continuing safety studies.
Regeneron called it quits on an experimental osteoarthritis pain treatment that has raised safety flags and an experimental antibody for cat-allergic asthma.
Abeona Therapeutics will head to the FDA next year for the potential approval of its experimental recessive dystrophic epidermolysis bullosa (RDEB) therapy following positive Phase III data.
Emalex Biosciences closed a Series D funding round Thursday counting $250 million in earnings, much of which will bankroll a Phase III trial of ecopipam for Tourette syndrome.
Exelixis has inked a licensing agreement with Catalent to gain access to three of Catalent’s target programs with antibody and ADC candidates, the companies announced Thursday.
Moderna is dropping an IL-12 program in autoimmune disorders after AstraZeneca returned the rights, the mRNA leader announced Thursday in its third quarter filing.
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.