Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Serpex Medical, Viewray.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Amylyx, Aston, Astrazeneca, Bausch + Lomb, Novaliq, Novavax, Tenaya.
Tenaya Therapeutics Inc. has received FDA clearance of its IND application to begin clinical testing of TN-301, a highly selective small-molecule inhibitor of histone deacetylase 6 (HDAC6) initially being developed for heart failure with preserved ejection fraction (HFpEF).
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).
Thirteen months after Illumina Inc. and Grail Inc. merged, prior to regulatory approval, the deal has taken a turn for the worse. The prognosis looked better following an administrative law judge’s ruling Sept. 1 against the U.S. Federal Trade Commission’s lawsuit seeking to block the transaction, but the European Commission (EC) issued a decision Sept. 6 prohibiting the deal based on the likelihood that a merger would stifle innovation and limit choices in the early cancer detection liquid biopsy market.
Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis candidate, AMX-0035, will get a rare second bite at the adcom apple Sept. 7. This time around, the Cambridge, Mass.-based company is looking to improve on its first performance by stressing the survival benefit of its drug.
China has upheld a recent ruling on a dispute between Chugai Pharmaceutical Co. Ltd. and Wenzhou Haihe Pharmaceutical Co. Ltd. over a generic form of an osteoporosis treatment. The move is seen as an indicator that patent protection for drugs has improved in China.
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Magnus Medical, Syntheticmr.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azurity, Bayer, Boehringer, Immuneering, Intellia, Moderna, Novavax, Y-mabs.
RSS
