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Also called an umbrella or basket trial, the master trial allows for a more targeted approach to cancer treatment, faster patient enrollment and the flexibility to pivot.
FDA
Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
With uncertainty rocking the venture capital market in the biotech and pharma industry, analysts from JLL give their thoughts on what the market looks like and where it may be heading.
Companies and patients alike are questioning the Federal Trade Commission’s challenges to various biopharma agreements.
How can startup leaders support long-term sustainable growth and investment? BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding.
Shares of several biopharma companies in the CAR-T space dropped after the FDA’s announcement, but analysts remain optimistic about the sector’s future.
Carl Icahn is seeking to get rid of “legacy conflicted directors” on Illumina’s board following the announcement that GRAIL will be divested after a drawn out antitrust battle with regulators.
Israel-based cancer immunotherapy company Compugen will receive $60 million upfront from Gilead for the license to its antibody, which blocks the interaction between the IL-18 binding protein and IL-18.
Cash-strapped bluebird bio is aiming to raise a quarter of a billion dollars through two funding vehicles—a public offering and a deal with finance firm Alterna—to support its general and commercialization operations.
The combination of Jemperli and chemotherapy followed by Zejula improved progression-free survival in a late-stage study of patients with advanced or recurrent endometrial cancer.
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