Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Ascletis, Cortexyme, Gilead, Hope, Ibio, Immunocore, Incyte, Molecular Targeting.
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.
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.
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.
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.
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.
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.
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would take a more proactive role in identifying and facilitating labeling updates, the U.S. FDA issued a draft guidance Jan. 25 intended to help holders of abbreviated new drug applications (ANDAs) keep their labels up to date with that of the RLD.
Eli Lilly and Co. has the dubious distinction of receiving the first untitled letter in 2022 from the FDA’s Office of Prescription Drug Promotion. The letter, sent Jan. 19 and posted this week, takes the Indianapolis-based company to task for an Instagram ad promoting Lilly’s diabetes drug Trulicity (dulaglutide).
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
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