Despite a newly signed $645 million commercialization deal with Neuraxpharm Group for multiple sclerosis drug Briumvi (ublituximab) in Europe, shares of TG Therapeutics Inc. (NASDAQ:TGTX) tanked by 49.3% on Aug. 1 due to a perceived miss in U.S. net sales for the anti-CD20 monoclonal antibody during its first full quarter on the U.S. market. Read More
Revolution Medicines Inc. is acquiring Eqrx Inc. in an all-stock transaction designed to add more than $1 billion in net cash for Revolution so it can forge ahead with its RAS pathway programs. Serial biotech entrepreneur and investor Alexis Borisy co-founded Eqrx in 2020 to deliver new medicines for cancer and other conditions at "radically lower prices." Borisy also co-founded Revolution, where he remains as executive chairman. Read More
About two months ahead of the planned PDUFA date, the U.S. FDA has granted expanded approval of PD-1 antibody Jemperli (dostarlimab) from partners Anaptysbio Inc. and GSK plc for use in combination with standard-of-care chemotherapy. GSK said the drug would be the only frontline immuno-oncology treatment for endometrial cancer available in combination with carboplatin and paclitaxel. The supporting supplemental BLA for the expanded indication previously received priority review. Read More
Newco Renaissance Pharma Ltd. has been formed to take a new treatment for neuroblastoma developed at St Jude’s Children’s Research Hospital through to market. The product, Hu14.18, has been in-licensed following a phase II trial conducted at the hospital in which patients with newly diagnosed high-risk neuroblastoma had a three-year event-free survival of 73.7% and an overall survival of 86%. Read More
Celloram Inc., the U.S. subsidiary of the Seoul, South Korea-based Medpacto Inc., signed a €160 million (US$175.88 million) licensing deal with Genfit SA to develop Celloram’s inflammasome inhibitor, CLM-022, for liver disease. Read More
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference. Read More
The U.S. FDA unveiled a proposal to once again reshuffle its operations, this time with a greater degree of emphasis on the function of the Office of Regulatory Affairs (ORA). Tim Philips, a consultant with Gardner Law and a former member of the FDA, told BioWorld that while these changes will likely yield some useful efficiencies, they might also dilute some of the more useful interaction between industry and FDA, a loss that may be keenly felt when it comes to matters such as FDA inspections. Read More
New hires and promotions in the biopharma industry, including: Ambrx, Auron, Bausch + Lomb, Cell and Gene Therapy Catapult, Harpoon, Kiora, Nerviano, Theracosbio, Zentalis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications:4D, Annexon, Apellis, Biosion, Clearside, Enlivex, Ionis, Mymd, Natera, Regeneron, Sunovion, Taysha, Tonix, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Acrotech, C4X Discovery, CASI, Emergent, Gradalis, Genosera, Indivior, Maxcyte, Mundipharma, Prime, Proqr, Ridgeback, Xinnovation. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridgebio, Biohaven, Citius, GC, Harm Reduction, Invectys, Marinus, Merck & Co., Moberg, Nanjing Leads, Redhill, Spero, Transcenta. Read More
