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The FTC’s lawsuit to block the merger of Amgen and Horizon violates the companies’ right to due process as, with the case relegated to an administrative law judge (ALJ) and not a jury, the commission will be “playing the roles of ‘investigator, prosecutor, and judge,’” the companies said in their June 29 counterclaim filing. Read More
Feedback on the FDA’s draft guidance for incorporating clinical outcome assessments (COA) into endpoints has trickled in from a number of stakeholders, including BIO and the International Society for Cell & Gene Therapy, who feel the guidance would be well served with expansion and clarification in certain areas. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
This is Lilly’s second biopharma acquisition in June having announced a planned purchase of Dice Therapeutics for approximately $2.4 billion. Read More
Deeply embedded supply chain challenges, such as “just in time” manufacturing methodology and sole sourcing to maximize profit, are key drivers of low inventories and offshoring, said Mark Abdoo, associate commissioner of FDA’s Office for Global Policy and Strategy (OGPS) in a recent speech. Read More
Drugmakers should make use of risk-based thinking to help prevent “catastrophic failures,” said quality expert Amanda McPharland in a June 14 WCG FDAnews webinar. Read More
Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B. Read More
Panelists said that there are no currently approved targeted therapies and there exists a dire patient need for treatments, they were troubled by Ipsen’s pivotal late-stage study data. Read More
The FDA’s final guidance on developing drugs and biologics to treat chronic rhinosinusitis with nasal polyps shares considerations sponsors should make for trial design/population, safety, effectiveness, and statistical analysis. Read More
Eli Lilly announced Thursday that it will acquire the privately held biopharmaceutical company Sigilon Therapeutics with the goal of developing encapsulated cell therapies for the potential treatment of type 1 diabetes. Read More
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
A lack of conclusions or follow-up in written records of investigations into unexplained discrepancies since 2020 for Duopa Intestinal Gel (levodopa-carbidopa) prompted FDA investigators to issue a Form 483 to AbbVie’s North Chicago, Ill., facility following a Jan. 23-31 inspection. Read More