Compugen Ltd. has entered another collaboration, this time exclusively licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million. Read More
On-again, off-again investor enthusiasm for Uniqure NV’s Huntington’s disease (HD) gene therapy AMT-130 got another boost as the company followed this summer’s news from phase I/II trials with additional interim data. Shares of Uniqure (NASDAQ:QURE) closed Dec. 19 at $6.64, down $1.34, or 17%, as the company offered results on up to 30 months of follow-up from 39 patients enrolled in the ongoing U.S. and European experiment. Read More
Chinese patients will soon have wider access to newly approved cancer drugs following the publication of the 2024 National Reimbursement Drug List (NRDL) that added 126 new drugs to the list. Price cuts to drugs averaged 61.7%. The additions and cuts are in line with the previous year. Read More
South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024. Read More
October marked a milestone in biopharma history, with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s $22 billion deal the largest in BioWorld’s records going back to 2014. Tokyo-based Daiichi is granting rights to three of its DXd antibody-drug conjugate candidates for the treatment of multiple solid tumors: ifinatamab deruxtecan, patritumab deruxtecan and raludotatug deruxtecan. The companies will co-develop and co-commercialize the three candidates worldwide, excluding Japan, where Daiichi retains exclusive rights. Read More
Radiopharmaceuticals continued to be a hot commodity in 2023, with new entrants entering the space and a flurry of deals continuing to spark interest. Read More
With the use of artificial intelligence (AI) increasing in both biopharma R&D and the regulatory science used to evaluate new drug candidates in member states, the EMA and Heads of Medicines Agencies have laid out a five-year workplan to ensure that the European medicines regulatory network remains at the forefront in benefiting from AI in medicines regulation. Read More
The data package for Filsuvez (birch triterpenes), a topical gel aimed at treating partial thickness wounds, satisfied U.S. reviewers the second time around. Chiesi Group said the FDA approved the treatment Dec. 19 for use in patients 6 months and older with rare blistering skin diseases junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abvacc, Allay, Astrazeneca, Biogen, Biomed X, Biontech, Compugen, Curevac, Eli Lilly, Evotec, Grid, Infinimmune, Innate, Limmatech, Maruishi, Organon, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anheart, Arcutis, Avstera, Catalyst, Checkpoint, Cyclo, GC Pharma, Innovent, Irlab, Lexeo, Merck & Co., Novavax, Nrx, Pfizer, Santhera, Sirnaomics. Read More
