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To aid drug and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue. Read More
A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due to the Inflation Reduction Act’s (IRA) drug pricing provisions. Read More
Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a pharmaceutical advertising scheme. Read More
This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s purchase of Silk Road Medical. Read More
The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Read More
Novo Nordisk announced plans to invest $4.1 billion to build a fill and finishing manufacturing facility in North Carolina and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases. Read More
The war against fake GLP-1 inhibitors is heating up, with Eli Lilly filing six suits against med spas and wellness centers selling unapproved versions of its patented tirzepatides — Mounjaro and Zepbound — with WHO and National Association of Boards of Pharmacy (NABP) also issuing alerts on the problem. Read More
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
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