Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actinogen, BMS, Celltrion, Innocare, J&J, Novavax, RDIF, TG.
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.
Just weeks after seeing one late-stage candidate hit a wall in a subtype of non-small-cell lung cancer (NSCLC), Merck KGaA's EMD Serono has won accelerated approval from the FDA for another important NSCLC therapy, Tepmetko (tepotinib).
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, EMD, Intrommune, Karyopharm, Sinovac, Theratechnologies.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA weighing Xeljanz safety results; EMA initiates OPEN collaboration; NICE evaluating guidance processes; TGA seeking comments; USPTO extends program with Japan’s, Korea’s patent offices; NICE recommends Keytruda in NSCLC; Florida researcher indicted.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamas, Amgen, Applied, Argenx, Biogen, Janssen, Jeil, Merck, Mirum, Rockwell, Vyne, Zosano.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Asana, Biocryst, Innovent, Prothena, RDIF.
HONG KONG – Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for Biocryst Pharmaceuticals Inc.’s Orladeyo (berotralstat), the first and only drug for prophylactic treatment of hereditary angioedema (HAE) approved in the country. Biocryst’ partner, Torii Pharmaceutical Co. Ltd., will launch the drug after completing pricing negotiations with the Japanese National Health Insurance System (NHI). Tokyo-based Orphanpacific Inc., Biocryst’s representative in Japan, holds the marketing authorization.
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