Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
A woman who allegedly made nearly $300,000 last year on insider trading based on undisclosed information about a pending biopharma acquisition will have to disgorge her profits, along with interest, to the U.S. Treasury, but she will face no other penalties.
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers.
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.
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