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The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
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AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
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Eli Lilly and Company announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection significantly reduced the apnea-hypopnea index compared to placebo, achieving the primary endpoints.
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The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.
The new version of the bill will still need to go through the entire House and Senate.
Andembry is the first monthly Factor XIIa inhibitor for the prevention of HAE attacks and will be available to patients “before the end of June,” CSL announced.
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.
BioNTech said in 2022 that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Now, the mRNA biotech is buying that very company.
Sanofi paid a more than 300% premium on its acquisition of Vigil Neuroscience, suggesting a fierce battle to seal the deal. Across biopharma, companies are sometimes willing to put it all on the line for the right buyout. Novartis’ recent acquisition of Regulus for $800 million upfront provides a case study.
The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
Nearly $30 million in tax incentive awards are expected to add 1,519 new life sciences jobs in Massachusetts, with about 52% of the positions spread over Boston and Cambridge. Vertex, which received the largest award, will create hundreds of roles in Boston.
Jefferies analysts said on Tuesday that Ventyx could leverage its mid-stage data for VTX3232 to position the oral drug candidate as a treatment for other neurodegenerative diseases, including Alzheimer’s.