News

While both Beam Therapeutics and Wave Life Sciences touted notable biomarker benefits for their respective alpha-1 antitrypsin deficiency assets, analysts said that Beam might have the efficacy advantage as Wave’s drug hits an efficacy “ceiling.”
FEATURED STORIES
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.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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.
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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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One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
BioSpace checked in with some of the members of our NextGen Bio Class of 2022 to see what they’ve done to earn their place on the list - and what’s on the horizon.
Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
GSK terminated its cell therapy pact with Lyell Immunopharma. It’s opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.
AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
Taysha Gene Therapies has entered into a strategic equity investment and licensing deal with Astellas. The latter stands to gain access to Taysha’s gene therapy development programs for Rett syndrome and GAN.
Data from two Phase I trials indicate Gritstone Bio’s samRNA vaccine can safely induce a strong and durable immune response against COVID-19.
In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.