On October 22, Novo Nordisk (Novo) nominated semaglutide products, which include its popular drugs marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, for inclusion on FDA's Demonstrable...more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
Until recently, Ozempic was a little-known diabetes medication. But, when mainstream media outlets and even medical schools began touting the drug’s weight loss benefits, Ozempic was quickly thrust into the national...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less...more
M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more
By rule, a petitioner may request permission from the Board to submit supplemental information in an IPR proceeding if: (1) the request is filed within one month of the Board’s institution decision, and (2) the supplemental...more
In a case that highlights the importance for petitioners to conduct a thorough prior art search and to anticipate patent owner’s arguments, the PTAB denied a motion to submit supplemental information under 37 C.F.R. §...more
Big Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and...more