As one of its last items of business before leaving town for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over…

An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Source: Drug Industry Daily

A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Source: Drug Industry…

The European Medicines Agency developed a continuity plan to handle the workload linked to the UK’s withdrawal from the European Union and the relocation of the EMA’s headquarters. Source: Drug…

Daiichi Sankyo agreed to settle nearly 2,300 liability lawsuits relating to its blood pressure drug Benicar. Source: Drug Industry Daily

Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Source: Drug Industry…

Pharmaceuticals executives view government-sponsored hackers as the top cybersecurity threat, according to a new survey from KPMG. Source: Drug Industry Daily

A New York federal judge threw out a case against Pfizer and Bristol-Myers Squibb that accused them of downplaying a drug’s bleeding risk. Source: Drug Industry Daily

The FDA sent warning letters to four compounding pharmacies, reminding them of their obligations under federal law to compound drug products based on valid prescriptions, while one compounder told the…

Senate Majority Leader Mitch McConnell (R-Ky.) said the FDA user fee reauthorization will be voted on before the Senate adjourns for its summer recess, scheduled to begin Aug. 14. Source:…