Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
Novo Nordisk A/S is the latest drug company to be challenged by U.S. Sen. Bernie Sanders (I-Vt.), who has made tilting at prescription drug prices one of the hallmarks of his tenure as chair of the Senate Health, Education, Labor and Pensions (HELP) Committee.
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
As Novo Nordisk A/S has struggled with supply of its GLP-1 drug Wegovy (semaglutide), its controlling shareholder, Novo Holdings A/S, has agreed to acquire global contract development and manufacturing organization Catalent Inc. and its more than 50 global sites for $63.50 per share in cash, about $16.5 billion.
With drug shortages becoming a fact of life, U.S. President Joe Biden said he plans to issue a presidential determination to broaden the Department of Health and Human Services’ (HHS) authorities under the Defense Production Act to enable investment in the domestic manufacturing of essential medicines, medical countermeasures and other critical inputs that the president deems essential to the national defense.
