A glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose with no plateau over 48 weeks in a phase III trial conducted in China.
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
Nearly six years after Ichnos Sciences Inc. launched operations, a subsidiary of the now-named Ichnos Glenmark Innovation (IGI) Inc. has signed with Abbvie Inc. a global licensing partnership for trispecific antibody ISB-2001 worth $1.925 billion plus royalties. ISB-2001, which targets BCMA, CD38 and CD3, is in a phase I trial for relapsed/refractory multiple myeloma and has orphan drug and fast track status in the U.S
The U.S. FDA said June 25 it has required updates to the prescribing labels of COVID-19 mRNA vaccines Comirnaty and Spikevax to include new safety information on the risks of myocarditis and pericarditis.
Taking an unconventional path to market for its targeted therapies for RAS-addicted cancers, Revolution Medicines Inc. secured access to $2 billion in capital to build its own global commercial infrastructure, instead of partnering outside the U.S. as it had originally intended. “We’ve concluded that the best way for us to achieve our goals with our rich pipeline is to direct our own global development and commercial strategies and to operationalize these both inside and outside the U.S. through our own organization,” Mark Goldsmith, president and CEO of Revolution Medicines (Revmed), told investors June 24.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
For years, the biopharma industry has spent increasing amounts of money on R&D without improving success rates, leaving many executives searching for new, more predictable drug development paths.
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
The COVID-19 pandemic sent the world into a tailspin, raising ongoing concerns about biosecurity, a subject that encompassed the better part of the morning June 16, the first day of the Biotechnology Innovation Organization’s annual conference in Boston.
