Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Creative Medical, Diurnal, Innovent, Lantheus, Merck, Moderna, Neurosense, Veralox.
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Amydis, Axcella, Boehringer, Chipscreen, Cytokinetics, Editas, Eli Lilly, Ideaya, Istari, Exicure, Lysogene, Neuren, Obseva, Organogenesis, RDIF, Receptor Life Sciences, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bayer, Glaxosmithkline, Medicure, Merus, Moderna, Neoleukin.
The latest global regulatory news, changes and updates affecting biopharma, including: Health care bills become U.S. law; MHRA releases safety review of epilepsy drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Bluerock, Gemini, Glycomimetics, Inversago, Praxis Precision, Union, Visen.
LONDON – The EMA has recommended approval of Moderna Inc.’s COVID-19 vaccine, becoming the fourth western regulator to do so, after Israel approved the product on Jan. 5 and the FDA and Health Canada in December.
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit: Nonsensical claims indefinite; USPTO seeks more uniformity between PTAB, courts; EC investing in startups.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Astellas, Astrazeneca, Everest, Inventiva, Moderna, RDIF, Redhill, Stealth.
HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion.
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