Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, granted a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
Ukrainian trial researchers grapple with logistical issues as Aeterna Zentaris warns war has delayed phase III trial
Headlines the world over have been dominated by the resilience of the Ukrainian military, but the country’s clinical research body said that amid the chaos of war, trials are also carrying on despite the destruction of hospitals and civilian infrastructure. As revealed by BioWorld, big pharma sponsors are putting clinical studies on hold in Russia, Ukraine and Belarus as the war plays havoc with medical supplies and the normal functioning of society. But according to the Ukrainian Association for Clinical Research, sponsors and contract research organizations have begun to find solutions to the problems caused by the closure of many supply routes.
BMS enters potential $1B-plus synthetic lethality pact with Volastra
Volastra Therapeutics Inc., taking aim at chromosomal instability (CIN) to design cancer drugs by way of its CINtech platform, scored a potential $1 billion-plus agreement with Bristol Myers Squibb Co. to find synthetic lethal targets as drug candidates. BMS pledged $30 million up front plus potentially as much as $1.1 billion more if development, regulatory and commercial milestones are met. The deal includes two targets and may be expanded to three.
Shares dip as Immunogen reports full phase III data with mirv in ovarian cancer
Immunogen Inc. unveiled full results from the pivotal study called Soraya testing mirvetuximab soravtansine monotherapy in patients with folate receptor alpha-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab, Roche Holding AG). The overall response rate remained the same as earlier-reported top-line data, but the median duration of response improved by a month. Shares (NASDAQ:IMGN) were trading midday at $4.14, down $1.12, or 21.2%.
US FDA’s VRBPAC to consider future of COVID-19 boosters
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). At that meeting, the committee will be asked to discuss considerations for future COVID-19 booster doses and the process for selecting specific strains of the SARS-CoV-2 virus that should be targeted by vaccines.
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Aeterna Zentaris, Alzecure, Amylyx, Athira, Atom, Aulos, Aura, Bavarian Nordic, Bayer, Bioarctic, Biomarin, Bristol Myers Squibb, Cortexyme, Eisai, Evommune, Evotec, Glenmark, GT, Immunogen, Kye, Lineage, Moderna, Neurosense, Nuance, Ortho Regenerative, Oryzon, Primmune, Provention, Pulmatrix, Qu Biologics, Revance, Rnagene, Sorrento, Saniona, Sqz, Tonix, Travere, Turning Point, Uniqure, Vallon