The FDA has one question for its Psychopharmacologic Drugs Advisory Committee when it meets Nov. 4: Has Levo Therapeutics Inc. provided substantial evidence that the company’s carbetocin nasal spray is effective in treating hyperphagia associated with Prader-Willi syndrome?
It looks like direct Medicare drug price negotiations are back in the U.S. fiscal 2022 budget bill.
Nearly a week after President Joe Biden dropped drug pricing reforms from his Build Back Better budget framework, congressional Democrats came together on a scaled-back version of the pricing provisions originally included in H.R. 3.
Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency.
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.
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