After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.
Philips Respironics Inc., of Murrayville, Pa., was compelled to engage in multiple recalls over the use of a supplier’s polyester-based polyurethane (PE-PUR) sound abatement foam, and the latest victim of this problem is the company’s Trilogy Evo ventilator.
The semiconductor industry has been hit hard by shortages of computer central processing units (CPUs) in recent months, but the persistence of these shortages has prompted a new response from industry. The Advanced Medical Technology Association (AdvaMed) said device makers are taking steps to ease the crunch, but that the Biden administration must take steps to ensure that medical technologies do not suffer from shortages, given the critical role played by devices in patient care.
The U.S. FDA often has difficulty turning around draft guidances into final guidances in a timely manner, but that hasn’t impeded the agency’s appetite for fast turnaround of industry responses to FDA mandated postmarket surveillance studies. Nonetheless, the Medical Device Manufacturers Association (MDMA) said in comments to the docket for the May 2021 draft guidance for Section 522 postmarket surveillance studies that a requirement that such a study be fully enrolled within 24 months should be aspirational rather than compulsory.
In keeping with its Drug Competition Action Plan released in 2017, the U.S. FDA finalized two guidances this week focused on the submission and review of generic drugs.
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab).
Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.
The U.S. Preventive Services Task Force (USPSTF) has once again broached the question of whether screening for atrial fibrillation (AF) in asymptomatic patients is a worthwhile exercise in public health, and once again the answer is “we don’t know.”
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
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