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.
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.
Trumprx.gov launched with much fanfare late Feb. 5, and the online tool brings promise for the “world’s lowest prices” on prescription drugs. Alongside the website hoopla came word from Hims & Hers Health of its own steep discounts on what’s to be the compounded version of a Trumprx-featured therapy: oral Wegovy (semaglutide) for obesity. Novo Nordisk A/S, Wegovy’s originator, vowed to fight.
In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.
In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.
At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.
The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.