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By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
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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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BioNTech SE (Nasdaq: BNTX, “BioNTech”) will welcome its African partners for the first time on the African continent and provide an update on the joint establishment of mRNA manufacturing facilities and vaccine development plans.
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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.
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The clinical development pipeline for vaccines is broad but shallow with a large proportion of programs dedicated to COVID-19, according to a new report by industry group Biotechnology Innovation Organization.
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
The FDA’s myriad acronyms—and the differences between them—can be perplexing. BioSpace looks at the unique advantages of certain regulatory classifications for drug developers.
While the company expects sales growth to be flat this year, Lonza’s shares jumped around 14% Friday morning after reporting full-year 2023 sales of $7.75 billion, which was 3% above the consensus.
Late Thursday, ArriVent Biopharma announced its upsized initial public offering to support the development of its EGFR inhibitor furmonertinib, following CG Oncology going public earlier in the day.
While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
With the FDA’s approval on Thursday, Dupixent can now be used for the treatment of children aged 1 to 11 years who have eosinophilic esophagitis, a chronic disease that can severely impact their ability to eat.
Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.
Despite myriad stumbling blocks over the past two years, experts still see the potential of Bruton’s tyrosine kinase inhibitors to quiet progressive multiple sclerosis.