Can the market justify the hundreds of GLP-1 developers that are working to eventually reach the market? When the dust settles, Minji Kim, CEO of Cross Border Partners and Advisory Service, told attendees at the Biotech Showcase in San Francisco, only a few leading companies will end up dominating the field.
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).
Peptidream Inc. has released promising results from preclinical testing of its oral myostatin inhibitors, administered in combination with semaglutide, in a mouse model of obesity.
Peptidream Inc. has announced a new peptide radiopharmaceutical development candidate, PD-29875, a novel first-in-class highly selective macrocyclic peptide-radioisotope conjugate against Claudin 18.2 (CLDN18.2).
The European Commission approved Novo Holding A/S’ acquisition of Catalent Inc., a global contract development and manufacturing organization expected to help Novo Nordisk A/S keep up with increasing demand for its GLP-1 drug, Wegovy (semaglutide).
Although head-to-head results on tolerability were missing from the company’s data release, Eli Lilly and Co. said its U.S. FDA-approved weight-loss drug Zepbound (tirzepatide) beat the also-cleared Novo Nordic A/S compound Wegovy (semaglutide) in a phase IIIb study comparing the two.
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