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The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
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Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
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Topline overall survival results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival, numerically favored datopotamab deruxtecan compared to docetaxel in the overall trial population of adult patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior line of therapy.
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Read our takes on the biggest stories happening in the industry.
Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.
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The transaction is expected to close in the second half of 2025. With the deal, Merck KGaA is adding to its rare disease and oncology pipelines.
With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air.
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
The cell and gene therapy company is cutting 47 employees and its entire lupus program to focus resources on two CAR Ts. The move follows a reconfiguration last year to move into immunology.
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics business, plus the same macro headwinds blowing against the entire industry.
The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent observation of testicular toxicity in canines given the treatment.
Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.
Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track.
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.