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BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
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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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.
A Louisiana woman has filed a lawsuit alleging that Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro did not have warnings about the risk of severe gastrointestinal problems.
During Regeneron’s second-quarter earnings call Thursday, the company said that the regulator could make its decision on 8-mg Eylea in the third quarter—much earlier than market expectations.
The biotech Thursday reported that second-quarter sales of its COVID shot dropped 94%. However, it expects $6 billion to $8 billion in revenue this year, up from a previous forecast of $5 billion.
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
Savings from just four of 10 drugs covered by the Inflation Reduction Act’s Drug Negotiation Program could reach $1.8 billion during the first year of implementation, according to research.
The lawsuit alleges that Pfizer infringed GSK’s patents on respiratory syncytial virus shots. The complaint comes just months after both companies had their respective RSV vaccines approved.
Early research and anecdotal evidence indicate that the popular diabetes and obesity drugs could treat some patients with addictive disorders.