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.
Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
Wall Street pushback against relaxin player Tectonic Therapeutic Inc. was sharp, but a trial design that differs could save the drug from the fate of Astrazeneca plc’s long-acting relaxin-2 analogue, AZD-3427, which the pharma giant has “removed from phase II,” where it was being tested in a trial called Re-phire, because of less than ideal efficacy.
Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease.
Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.
After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
Global investors in med tech are confident about exit opportunities in the year ahead. The strategics have already started making acquisitions, the IPO window – which reopened last year – is expected to remain active, and the investment firms have companies in their portfolios that are well-positioned for exit. With fundamentals in the sector still robust, 2026 is expected to reward companies that deliver clear clinical value.
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.
Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.
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