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On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
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A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.
Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, myasthenia gravis and other conditions traced to misdirected immune response.
This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets.
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BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Alexander Hardy , President and Chief Executive Officer of BioMarin, will present at the 42nd Annual J.P. Morgan Conference on Monday January 8, 2024 , at 10:30 am PT / 1:30 pm ET , in San Francisco, California.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys 51 in a patient population amenable to exon 51 skipping.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
Ionis and Ultragenyx are competing to develop oligonucleotide treatments for Angelman syndrome, but will Neuren’s peptide catch up?
The Maryland-based biopharma joins Eli Lilly and Novo Nordisk in trialing a GLP-1 agonist for alcohol- and liver-related conditions.
Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors.
Sutro’s stock tumbled nearly 19% after the company announced it will sideline its FRα-targeted antibody-drug conjugate luveltamab tazevibulin, which it was studying for ovarian cancer. The biotech will seek licensing opportunities for the asset.
Pliant follows in the footsteps of Acelyrin, which also enacted a stockholder rights program on Thursday to protect shareholders against Tang Capital’s growing stake in the company.
The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.
As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.”