Mersana Therapeutics Inc. has signed a potential billion-dollar agreement with Johnson & Johnson’s Janssen Biotech Inc. to research and develop antibody-drug conjugates (ADCs) for three cancer targets. Janssen will pay $40 million up front as well as more than $1 billion in potential milestone payments in a big day for ADCs, which saw Mersana’s other development partner, Synaffix BV, announce a tie-up with Macrogenics, Inc. in a deal worth up to $586 million. Read More
LONDON – Another month, another deal for antibody-drug conjugate (ADC) specialist Synaffix BV, which has sealed a $586 million, three-target agreement with Macrogenics Inc. No details of the targets or the indications were disclosed, but Synaffix CEO Peter van de Sande said this is “an important milestone” because it will be the first time the company’s linkers and payloads have been attached to a bispecific antibody. Read More
Just weeks after signing a targeted RNA degrader deal with Arrakis Inc., Amgen Inc. has enlisted protein degrader specialist Plexium Inc. to a new deal in the high-profile field. "We're on the cusp of a new era of drug discovery, where medicines could function very differently than conventional ones do today," said Amgen's senior vice president of global research, Ray Deshaies. Read More
The dosing by Vincerx Pharma Inc., in mid-December of last year, of the first patient in the phase I study with VIP-152 marked the second experiment begun by the company in 2021, and added oomph to the already-growing renewal of interest in CDK9 as a therapeutic target. Read More
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years. Read More
Only three other years during the past three decades did the U.S. FDA approve more new molecular entities (NMEs) than the 50 cleared in 2021, a year that was plagued with numerous delayed decisions. There were 53 NME approvals in 1996 and 53 again in 2020. The record is held by 2018, which had 59 approvals. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aardvark, Crispr, Northsea, Oncolytics, PDS, Pharming, Tarsus, Tracon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amylyx, Glaxosmithkline, Johnson & Johnson, Merck, Mitsubishi Tanabe Pharma America, Pfizer, Qilu Regor, Regor, Ridgeback, Vir, Xbiotech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Jazz, Logicbio, Pfizer, Qsam, Samsung, Theseus. Read More
