Archive for March 2024

The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Source: Drug Industry Daily

An FDA advisory committee on Thursday gave its unanimous blessing to Balance Opthalmics’ FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system as a nightly use adjunct therapy for reducing intraocular pressure in adults with open-angle glaucoma and intraocular pressure 21 mmHg or less. Source: Drug Industry Daily

The FDA has identified product recalls for Vyaire’s AirLife Manual Resuscitators and for the use instructions for Abiomed’s left-sided heart pumps as Class I, while device manufacturer InfuTronix is voluntarily recalling its line of Nimbus Infusion Pumps after design flaws prompted thousands of customer complaints. Source: Drug Industry Daily

Over the past week, the FDA published a draft rule on drug products that present demonstrable difficulties for compounding. Final guidance was issued on controlled correspondence for generic drug development. Draft guidance on real-world evidence in drug and biological products’ non-interventional studies was also issued. Source: Drug Industry Daily

This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood disease, a new antibiotic to treat multi-drug resistant bacteria, and a generic multiple sclerosis drug treatment. Source: Drug Industry Daily

Sol-Millennium, one of the three syringe manufacturers called out in a March 19 FDA Safety Communication for potential device failures, says it is “confident” that it can resolve all issues identified in an FDA Warning Letter. Source: Drug Industry Daily

Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating…

In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Source: Drug Industry Daily

This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft putty, and Fujifilm’s AI-powered endoscopic imaging technology. Source: Drug Industry Daily

Medicare coverage of anti-obesity medications (AOM) — now CMS approved for cardiac patients — could drive up the federal deficit over the next decade, according to a new report issued by the Congressional Budget Office (CBO). Source: Drug Industry Daily