News

CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions.
FEATURED STORIES
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.
Phase III trial data published Thursday show significant survival benefit as a first-line treatment in advanced non-small cell lung cancer patients not fit for standard platinum-based doublet chemotherapy.
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.
FDA
Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.
The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.
The layoffs are a result of Sumitomo’s decision announced in April to combine its seven subsidiaries into one company.
The companies have signed two other pacts over the last year. In the latest deal, Takeda gains access to F-star’s platform to produce tetravalent antibodies for undisclosed oncology targets.
The Inflation Reduction Act could put an end to blockbuster runs like that of Merck’s Keytruda, experts told BioSpace. In the meantime, the drug keeps picking up more indications and positive clinical results.
The company has signed a memorandum of understanding and land collaboration agreement to develop medicines exclusively for Chinese use.
The pharmaceutical giant is tapping the world’s largest biomanufacturing facility operated by Samsung Biologics for biosimilar production.