More than 15,700 employees at 101 biopharma companies have lost their jobs in 2022 as industry leaders struggle to stay afloat in an uncertain and challenging economic environment. Firms have explained the layoffs by citing everything from asset prioritization and cost-efficiency to closing plants and drug failures. Read More
GSK plc may have pushed the door open Oct. 26 for the use of a new class of oral drugs to treat anemia in U.S. patients with chronic kidney disease who are dialysis dependent. The U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-3 that the benefits of GSK’s daprodustat outweighed the risks in that population. However, the committee didn’t push the door wide enough for patients not on dialysis, voting 5-11 on the question of whether the drug’s benefits outweighed its risk in the nondialysis population, even though that group conceivably could see a greater benefit. The test now is whether the FDA will follow the committee’s lead. Read More
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies. Read More
The changes continue at GSK plc as the pharma giant stepped away from its NY-ESO cell therapy program in moves that touch two collaborators. The company is terminating its three-year partnership with Lyell Immunopharma Inc. to develop candidates targeting NY-ESO-1, including the second‑generation product candidates, Lyell’s genetic and epigenetic reprogramming technologies (LYL-132 and LYL-331), and some other second-generation approaches GSK was considering. Read More
Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October. Read More
It’s a time of economic crisis and political upheaval in the U.K. But, according to the country’s pharma trade body, there’s another looming problem of access to clinical trials in the country, which is becoming less and less attractive as a place to conduct life sciences research. Read More
South Korea’s regenerative medicine market is expected to grow from $51 million in 2016 to $320 million by 2026, growing at a compound annual growth rate of 20%, So Ra Park, chair and founder of Korea’s Regenerative Medicine Acceleration Foundation said during the Ausbiotech 2022 conference in Perth, Australia, running Oct. 26 to 28. Read More
New hires and promotions in the biopharma industry, including: 3T, Biostem, Enveda, Expansion, Nimbus, Orexo, Scancell, Scynexis, TC, Twist, X4. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Applied, Astrazeneca, Atai, Avrobio, Can-Fite, Cardiol, Gristone, Imaginab, Inotrem, Oblato, Quadriga, Seelos and Ultimovacs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nervgen, Regenerx, Rznomics, Timber. Read More
