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.
An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men.
Abbvie Inc.’s FDA clearance of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, could bring relief to about 128 million Americans: almost half of the U.S. population, the company said. It’s the first and only eye drop given U.S. regulators’ go-ahead for what’s known as age-related blurry near vision – but plenty more have generated clinical data.
With the FDA approval of Scemblix (asciminib), a STAMP inhibitor for treating chronic myeloid leukemia (CML) in adults, Novartis AG has a companion to its longstanding therapy Gleevec (imatinib) as a treatment for the indication.
The FDA has granted emergency use authorization (EUA) to the COVID-19 vaccine created by Pfizer Inc.-Biontech SE for use in children ages 5 through 11. This is the first EUA for a COVID-19 vaccine to be awarded for this group of roughly 28 million children in the U.S. and it comes after weeks of lengthy debate among experts about the wisdom of targeting the young demographic.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA.
The world of artificial intelligence (AI) regulation is still in its infancy, but a number of agencies are nonetheless keen on harmonization for at least some of this policymaking task. The FDA announced recently that it has joined with Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency to develop a series of 10 guiding principles for good machine learning practices (GMLP), thus answering one of the key questions facing developers of these algorithms.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Detect, Renovia.
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