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The FDA “does not intend” to enforce the Drug Supply Chain Security Act (DSCSA) requirement that manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale until Nov. 27, 2024 the agency announced in a guidance published on Friday. Read More
HHS announced a slate of new funding initiatives this week, including $1.4 billion for Project NextGen to support development of novel COVID-19 technologies and $24 million for Curing the Uncurable via RNA-Encoded Immunogene Tuning (CUREIT), part of the Biden administration’s Cancer Moonshot program. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More
In a brief filed Monday, Amgen and Horizon argue that the U.S. District Court of Northern Illinois shouldn’t let the Federal Trade Commission (FTC) block their union over concerns that a dangerous monopoly on two blockbuster drugs will result. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said FDA Commissioner Robert Califf on Tuesday. Read More
The legal fight around the Inflation Reduction Act’s (IRA) drug price negotiation policy continues as the AARP and Public Citizen have submitted amicus briefs supporting the law and Boehringer Ingelheim filed a lawsuit, joining other drugmakers’ and the U.S. Chamber of Commerce’s challenges. Read More
The Department of Justice (DOJ) has resolved criminal antitrust charges against Teva Pharmaceuticals and Glenmark Pharmaceuticals for price fixing with deferred prosecution agreements, hefty fines, admission that the DOJ’s facts are true and a requirement to divest key lines of business. Read More
The FDA has issued multiple draft and revised product-specific guidances that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability. Read More