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.
The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Pulse Biosciences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Asana, Biocryst, Innovent, Prothena, RDIF.
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