The SEC filed civil charges against CBA Pharma Inc. and two top executives in U.S. district court, alleging they conducted a fraudulent securities offering that raised about $4.1 million from nearly 160 investors.
Novo Nordisk A/S’ television ad introducing the tablet form of its weight-loss drug, Wegovy (semaglutide), to American consumers didn’t pass regulatory muster.
As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultrarare neurodegenerative disease in dire need of new therapies.
Nextpoint Therapeutics Inc. has obtained IND clearance from the FDA to initiate clinical development of NPX-372, a first-in-class B7-H7-targeted T-cell engager (TCE) for the treatment of patients with solid tumors.
Zhejiang Difference Biological Technology Co. Ltd. (Diff Biotech)’s proprietary nasal spray influenza attenuated live vaccine, DIFF-flu, has received clinical trial approval from China’s National Medical Products Administration (NMPA).
True to its word, Novo Nordisk A/S filed a patent infringement lawsuit in U.S. district court against Hims & Hers Health Inc. over compounded versions of Novo’s semaglutide products.
Delonix Bioworks Ltd. has obtained IND clearance from China’s National Medical Products Administration (NMPA) for its group B meningococcal (MenB) vaccine candidate, DX-104. This follows the successful completion last month of clinical trial notification (CTN) procedures and ethics committee approval in Australia.
Beijing Innocare Pharma Tech Co. Ltd. has gained IND clearance in China to conduct clinical trials of ICP-538, an orally administered molecular glue degrader targeting VAV1, which is a key protein downstream of T-cell and B-cell receptors. ICP-538 is being studied for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus and multiple sclerosis.
Trumprx.gov launched with much fanfare late Feb. 5, and the online tool brings promise for the “world’s lowest prices” on prescription drugs. Alongside the website hoopla came word from Hims & Hers Health of its own steep discounts on what’s to be the compounded version of a Trumprx-featured therapy: oral Wegovy (semaglutide) for obesity. Novo Nordisk A/S, Wegovy’s originator, vowed to fight.
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