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The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug Enforcement Administration (DEA) Administrator Anne Milgram. Read More
The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind the issuance of 244 new and revised product specific guidances (PSG), including 174 for complex products. 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
Bristol Myers Squibb (BMS) and three US subsidiaries of Paris-based Sanofi owe the state of Hawaii a combined $916 million over safety disclosure failures with blood-thinning drug Plavix, following a state court decision Tuesday. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will attempt to balance the benefits of Novo Nordisk’s once-weekly insulin injection Awiqli with an increased risk of moderate and severe hypoglycemia at its May 24 meeting. Read More
Drug shortages, patent tussles, and gripes about the Inflation Reduction Act (IRA) headlined the conversation at an FDA “check-up” meeting conducted by the House Energy and Commerce’s subcommittee on health. Read More
Several senators on both sides of the aisle brought up the many bipartisan bills that have passed the House and Senate committees in recent years. Read More
NIH is seeking comments on a new policy that would require partnering organizations who receive institute funding to submit a plan outlining steps they will take — through a patent licensing agreement — to promote patient access to any resulting drug, biologic, vaccine or device. Read More
Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have an approved BLA. Read More
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More