A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the new therapy approved for Americans with HES in nearly 14 years, according to the FDA. An EMA filing in HES is expected later this year.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance.
Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies.
The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
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