While in the hot seat at a Sept. 24 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing, Novo Nordisk A/S President and CEO Lars Fruergaard Jørgensen said he would sit down with Sen. Bernie Sanders (I-Vt.) and the three largest pharmacy benefit managers to discuss lowering the list prices for the company’s popular diabetes and weight-loss drugs, Ozempic and Wegovy.
Interim phase II data of Wave Life Sciences Ltd.’s oligonucleotide, WVE-N531, revealed “impressive” dystrophin expression, solid safety and the potential for once-monthly dosing for boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping. The findings drove Wave Life’s stock (NASDAQ:WVE) up by 53.4%, or $2.85, to close Sept. 24 at $8.19, after peaking earlier in the day at $8.35, its 52-week high.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next.
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
What the results might mean for the future of other developers in the cannabinoid receptor 1 (CB1) weight-loss arena came into question after Novo Nordisk A/S unveiled phase IIa findings with monlunabant, a small-molecule oral inverse agonist, formerly INV-202.
Route 92 Medical Inc. sped past its series F goal, raising an additional $50 million in an extension to the oversubscribed round. The extension brings the total for the series F to $82 million, which the company plans to use to accelerate commercialization of its neurovascular reperfusion and access systems.
The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.
Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.
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