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. During a recession from 14 years ago, the industry also suffered thousands of workforce reductions, but they were estimated at about 5,000 jobs in 2008 and another 5,100 in 2009, which combined are still 36% less than the first 10 months of 2022.

GSK countering FDA’s exploratory analyses of daprodustat

It’s no secret that the U.S. FDA is critical of trial sponsors that use exploratory, post hoc analyses of subgroups to support approval of drugs that failed to meet their primary endpoints in clinical trials. Yet in today’s meeting of the Cardiovascular and Renal Drugs Advisory Committee, GSK plc had to counter concerns about daprodustat stemming from the FDA’s exploratory, post hoc analyses of subgroups even though the drug, by the agency’s own admission, met the co-primary endpoints – noninferiority – in two pivotal phase III trials that compared the oral drug with infused or injected erythropoiesis-stimulating agents in treating anemia in patients with chronic kidney disease.

Janssen’s teclistamab becomes first FDA-approved BCMA-targeting bispecific for multiple myeloma

The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma, joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies. Branded Tecvayli, teclistamab is indicated for adults who have received at least four lines of prior therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

GSK breaks up with NY-ESO program, dropping two collaborators

GSK plc is stepping away from its NY-ESO cell therapy program in moves that touch two collaborators. The company is terminating a three-year partnership with Lyell Immunopharma Inc. that sought to develop candidates targeting NY-ESO-1, including the second‑generation product candidates incorporating Lyell’s genetic and epigenetic reprogramming technologies (LYL-132 and LYL-331), as well as some other second-generation approaches. GSK then transferred the NY-ESO cell therapy program to Adaptimmune Therapeutics Inc. along with the rights to its PRAME cell therapy program. The terms are still being negotiated, but once completed GSK will cease to have any rights to nominate any additional targets, according to Adaptimmune.

FDA briefing docs question Y-mabs’ Omblastys data in neuroblastoma

The FDA posted briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee meeting to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) for the treatment of central nervous system/leptomeningeal metastasis from neuroblastoma. Earlier this month, New York-based Y-mabs offered data from the ongoing, pivotal Study 101 with Omblastys, a radioactive drug that works by targeting cells that express B7-H3, which inhibits the work of T cells. “The application does not include reliable response rate data to provide supportive evidence of the treatment effect” of the drug, regulators said in the documents. Omblastys bears a PDUFA date of Nov. 30. Shares of Y-mabs (NASDAQ:YMAB) were trading midday at $13.77, down $1.40, or 9.2%.

UK slides down list of top clinical trial sites as economic crisis deepens

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.

Ausbiotech 2022: Korea looking to accelerate regenerative medicine market

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.

Also in the news

Applied, Astrazeneca, Atai, Avrobio, Awakn, Bergenbio, Biohaven, Candel, Can-Fite, Cardiol, Gritstone, Imaginab, Immvira, Inotrem, Mogling, Nervgen, Oblato, Quadriga, Regenerx, Rznomics, Seelos, Taysha Gene Therapies, Timber, Ultimovacs, Vacv, Vaxcyte