New Anglo/U.S. obesity and cardiometabolic specialist Verdiva Bio Ltd. has launched with a massive $411 million series A and a portfolio of GLP-1 and amylin agonists in-licensed from China.
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markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
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).
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to halt its phase II trial testing oral obesity candidate azelaprag. The Strides study, launched in July, had been testing azelaprag, an oral apelin receptor agonist licensed from Amgen Inc., as a monotherapy and in combination with GLP-1/GIP therapy Zepbound (tirzepatide, Eli Lilly and Co.) in obesity.
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.
After raising AU$40 million (US$25.9 million) earlier this year to advance lead candidate VP-001 for treating retinitis pigmentosa type 11, PYC Therapeutics is now advancing PYC-003 to the clinic for polycystic kidney disease.
When U.S. CMS Administrator Chiquita Brooks-LaSure announced Nov. 26 that the agency is “reinterpreting” the law in proposing a rule allowing Medicare and Medicaid to cover obesity drugs beginning in 2026, she called it a “historic step.” The rule, if finalized, could make obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) available to millions more Americans and further invigorate development of other obesity drugs. But given the lateness of the day in the Biden administration, the proposal may be more symbolic than historic.
Wall Street began comparing and contrasting what’s available after Amgen Inc. rolled out phase II data with weight loss candidate Maritide – a disclosure that led shares of the biotech heavyweight (NASDAQ:AMGN) to close Nov. 26 at $280.01, down $13.99.
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