The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio when used in treatment of abdominal aortic aneurysms (AAAs). The panel concluded that the benefits of the device do outweigh the risks for some patients, although the applicable patient population is likely to be smaller than is currently seen in clinical practice.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued an advisory regarding the risk of anaplastic large cell lymphoma (ALCL) in association with breast implants, but stopped short of recommending explant for asymptomatic patients.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Magstim, Orasure, Perimeter Medical Imagining AI, Transit Scientific, Vuno.
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).
In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Achieve, Akeso, Amylyx, Antengene, Biotheryx, Boehringer, Eli Lilly, GC, Geneventiv, Ikena, Janssen, Landos, Legend, Nova Mentis, Novan, Tryp.
The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.
A former sales rep for Cambridge, Mass.-based Aegerion Pharmaceuticals Inc. was sentenced Oct. 28 to 54 months in prison and three years of supervised release for a scheme to defraud insurance companies and boost his bonuses for sales of Aegerion’s cholesterol drug, Juxtapid (lomitapide).
Biopharma scored a victory of sorts in the ongoing 340B war that’s pitting drug companies against the combined forces of hospital groups, contract pharmacies and the U.S. Department of Health and Human Services.
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