Announcing two licensing deals with Swiss pharma giant Novartis AG, Shanghai-based Argo Biopharmaceutical Co. Ltd. said on Jan. 7 that it stands to gain up to $4.165 billion for two of its cardiovascular assets combined. Marking the “first significant overseas out-licensing transaction in the RNAi field from a Chinese biotech company,” the deal includes an up-front payment of $185 million from Novartis to Argo.
Shares of Corcept Therapeutics Inc. (NASDAQ:CORT) fell 26% Jan. 2 on news that a U.S. court determined that Teva Pharmaceuticals Ltd. does not infringe on patents related to use of cortisol receptor blocker Korlym (mifepristone) in Cushing’s syndrome, opening the possibility of Teva’s generic version to enter the market.
The U.S. FDA issued a complete response letter for Zealand Pharma A/S’s NDA seeking approval of dasiglucagon for the prevention of treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism, citing deficiencies identified during an inspection at a third-party contract manufacturing facility.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
The advent of glucagon-like peptide-1 (GLP-1) receptor agonists has meant new hope for people with type 2 diabetes and obesity, but also has brought the challenge of muscle loss, which various drug developers are trying to ameliorate by way of mixed approaches.
In their year-end list of top scientific achievements and the people who made them, both Science and Nature have included the fight against “the obesity epidemic.” Science named GLP-1 drugs as its Breakthrough of the Year, while Nature included Svetlana Mojsov in its 2023 list of the year’s most important investigators. Mojsov is research associate professor at The Rockefeller University and was an early contributor to understanding the metabolic role of GLP.
The U.S. FDA is assembling a new advisory committee specifically focused on treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee, or GeMDAC, will be tasked with providing agency reviewers independent expert recommendations regarding regulatory applications as well as advice on scientific and policy issues.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Sanofi SA backed out of its $750 million effort to advance Maze Therapeutics Inc.’s oral Pompe disease candidate, MZE-001, after the U.S. FTC filed a federal lawsuit to block the deal, claiming the Paris-based firm was seeking to eliminate a nascent competitor.
Freeline Therapeutics plc is being taken private by its founding investor and majority shareholder Syncona Ltd, in an all-cash transaction that values the Nasdaq-listed gene therapy specialist at $28.3 million. Syncona also will provide up to $15 million cash to keep Freeline afloat as it awaits the next tranche of data on its lead program FLT-201, which is positioned as a one-off treatment for the lysosomal storage disorder, Gaucher’s disease.
RSS
