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The FDA is issuing exemptions from certain requirements of the Drug Supply Chain Security Act (DSCSA) to small dispensers such as pharmacies until Nov. 27, 2026. Read More
Generic sterile injectables — such as antibiotics, anesthetics and vaccinations — faced a 91 percent risk of being in short supply in 2023 and 58 percent of injectable drugs went into shortage in 2023, according to a report by the United States Pharmacopeia (USP). Read More
The judge explained that the court was ruling on the parties’ competing motions to exclude expert testimony under Rule 702 of the Delaware Rules of Evidence. Read More
The 340B Drug Discount Program needs more regulation, oversight and transparency to combat abuse by bad actors, according to members of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee. Read More
More than 70,000 Zantac cases may go to trial following Delaware Superior Court Judge Vivian Medinilla’s order allowing plaintiffs’ expert witnesses to testify in court that the drug may cause cancer. Read More
In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug manufacturers has requested an investigation of the drug buyers’ practices. Read More
Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More
A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and the Securities and Exchange Commission (SEC). Read More
Eli Lilly announced on Friday that it has more than doubled its investment in its Lebanon, Ind., manufacturing site with a $5.3 billion commitment that will expand its capacity to make active pharmaceutical ingredients (API) for tirzepatide (Mounjaro and Zepbound) as well its pipeline drugs. Read More
A federal appeals court has upheld a lower court ruling that the controversial 340B Drug Discount Program doesn’t stop drugmakers from restricting deliveries of discounted drugs to contract pharmacies. Read More