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Home » Newsletters » BioWorld

BioWorld

March 21, 2022

View Archived Issues
Opdualag

This is just the beginning, says LAG-3 discoverer as BMS grabs first-in-class approval

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
Pallet of boxes on top of map of Ukraine

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 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
Chromosomes 3d illustration

Wages of CIN could total $1B-plus for Volastra in synthetic-lethality BMS deal

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

Street serves mirv curve as Immunogen sinks on ‘positive’ phase III ovarian cancer trial readout

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
FDA vaccine illustration

US FDA preparing for a 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 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Read More
SEC-pic.png

US SEC moves toward requiring more reporting on climate change

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

US FDA pondering improvements to drug ingredient database

The U.S. FDA is seeking comments to help it improve the usability of the Center for Drug Evaluation and Research’s Inactive Ingredient Database.

Read More
ICYMI illustration

ICYMI: Week in review, March 14-18, 2022

A quick look back at top stories. Read More

Appointments and advancements for March 21, 2022

New hires and promotions in the biopharma industry, including: Athira, Avacta, Ceptur, Chinook, Crinetics, Jasper, Relief, Vaxxinity, Vivacitas. Read More

Financings for March 21, 2022

Biopharmas raising money in public or private financings, including: Qu, Revance. Read More

In the clinic for March 21, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Chiesi, Crinetics, Cstone, Merck, Recursion, Scilex, Sernova, Sorrento, Paradigm, Protalix. Read More

Other news to note for March 21, 2022

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 actions for March 21, 2022

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

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