Touting a series of firsts and a premium price tag to match, Immunocore Holdings plc is poised to launch the uveal melanoma drug tebentafusp in the U.S. following FDA approval for the medicine. The regulatory nod makes the drug, branded Kimmtrak, the first T-cell receptor-based therapy to reach the market, the first approval for a drug targeting gp100, and the first drug approved in 40 years for the cancer, which is the most common eye cancer in adults, though still rare. Read More
Nearly two years after Gilead Sciences Inc. spent $4.9 billion to buy Forty Seven Inc. and its lead candidate, magrolimab, the FDA clamped a partial clinical hold on five of Gilead’s clinical trials combining the therapy with azacitidine. The cause, according to Gilead’s management, is “an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.” The company said it has not identified a clear trend in the adverse reactions or new safety signals. Read More
LONDON – The EU’s third generation public-private research partnership in health formally got off the ground on Jan. 26, with a promise to invest €2.4 billion (US$2.7 billion) and back 30 large-scale, cross-sector innovation projects by 2030. The Innovative Health Initiative is the successor to the Innovative Medicines Initiatives 1 and 2, which between 2008 – 2020 put €5 billion into precompetitive research to accelerate translation of biomedical research to new drugs. Read More
Market pressure for M&As in the life sciences sector and the U.S. government’s determination to crack down on anything that smells of antitrust could be on a collision course this year that’s likely to result in injunctions and a lot more litigation. Read More
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region. Read More
Edigene Inc. has extended a long-running partnership with an academic lab at the Chinese Academy of Medical Sciences and Peking Union Medical College with the goal of co-developing hematopoietic stem cell regenerative therapies and technology for the treatment of inherited blood disorders, as well as the discovery of biomarkers to improve quality control of stem cell production. Read More
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions. Read More
Biopharmas raising money in public or private financings, including: American Cancer Society, Cellcentric, Concentric Analgesics, Kyverna, Sierra Oncology, Veneno Technologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annovis, Catalyst, Genentech, Imara, Mindmed, Mustang, Nanoscope, Neurophth, Oric, PTC, Senhwa, Snipr, Swanbio.
