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, 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. Read More
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 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. Read More
Volastra Therapeutics Inc., dedicated to 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. (BMS) to find synthetic lethal targets as drug candidates. Read More
Wall Street was not as pleased as some might have expected by Immunogen Inc.’s full results from the pivotal study called Soraya testing mirvetuximab soravtansine (mirv) monotherapy in patients with folate receptor (FR) alpha-high, platinum-resistant ovarian cancer (PROC) who have been previously treated with Avastin (bevacizumab, Roche Holding AG). Analysts hailed the results as positive but shares (NASDAQ:IMGN) closed at $4.30, down 96 cents, or 18.25%. Read More
"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 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Read More
If the U.S. SEC adopts a rule it proposed March 21, all public companies registered with the regulator, including biopharma and med-tech firms, will have to add disclosures about climate change to their other reporting obligations. Read More
New hires and promotions in the biopharma industry, including: Athira, Avacta, Ceptur, Chinook, Crinetics, Jasper, Relief, Vaxxinity, Vivacitas. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Chiesi, Crinetics, Cstone, Merck, Recursion, Scilex, Sernova, Sorrento, Paradigm, Protalix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzecure, Aulos, Bavarian Nordic, Bayer, Biolojic Design, Boehringer Ingelheim, Evotec, GT, Lineage Cell, Moderna, Nuance, Primmune, Rnagene, Pharmabcine, Saniona, Sorrento, SQZ, Washington University. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Cstone, Kiora, Moderna, Sobi. Read More
