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Results from a Phase I study presented Friday at the ASGCT 2024 annual meeting showed that despite a good safety profile, Excision BioTherapeutics’ HIV gene editor failed to suppress viral activity.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
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Honeywell announced a commercial partnership with AstraZeneca to develop and bring to market next-generation respiratory inhalers that use near-zero global warming potential propellants to treat asthma and chronic obstructive pulmonary disease.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
Following injection site reactions in a Phase I study, the company is developing a new formulation for its Friedreich’s ataxia candidate setting the asset’s clinical progress back significantly.
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.