Drug Industry Daily

CMS has issued a proposed rule that aims to spend $9 billion to reimburse nearly 1,650 hospitals participating in the 340B drug discount program for underpayment of fees over the past five years. Source: Drug Industry Daily

Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Source: Drug Industry Daily

The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Source: Drug Industry Daily

Multiple U.S. government agencies, in collaboration with India’s Directorate of Revenue intelligence, have stopped over 500 shipments of “illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.” Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Source: Drug Industry Daily

The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the “extraordinary regulatory flexibilities” that were put in place during the COVID-19 pandemic to ease potential medicine shortages. Source: Drug Industry Daily

The Association of Accessible Medicines (AAM) has filed a lawsuit against a new Minnesota law that controls pharmaceutical pricing, calling the law unconstitutional and discriminatory. Source: Drug Industry Daily

Eisai’s antiamyloid antibody Leqembi (lecanemab-irmb) has now gained full FDA approval — and the market advantage of full CMS coverage. Source: Drug Industry Daily

Over the past week, the FDA the FDA has requested comments on a Cardiovascular and Renal Drugs Advisory Committee meeting. Source: Drug Industry Daily