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Teva Pharmaceuticals has agreed to pay $420 million to settle shareholder litigation alleging the company concealed an anti-competitive scheme to fix the prices of about 50 generic drugs, according to court documents filed in the U.S. District Court for the District of Connecticut on Tuesday. Read More
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More
Countries need to shore up logistical and medical resources on the ground to facilitate vaccinating their citizens once the supply arrives, Hatchett said. Read More
Bristol Myers Squibb (BMS) subsidiary Juno Therapeutics has lost a bid to persuade a U.S. appeals court to overturn its own decision tossing out a $1.2 billion patent verdict that Juno won against Gilead Sciences subsidiary Kite Pharma. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
All is well between Eli Lilly and the FDA after the agency’s Office of Prescription Drug Promotion (OPDP) admonished the drugmaker for not submitting two direct-to-consumer TV advertisements for its migraine drug Emgality (galcanezumab) to FDA for consideration before the ads aired. Read More
The European Commission has laid out its regulations for selecting EU member states to evaluate suspected unexpected serious adverse reactions (SUSARs) that occur in clinical trials. Read More
The FDA has submitted its user fee reauthorization letters covering prescription drugs, generics and biosimilars to lawmakers — enabling Congress to begin crafting legislation authorizing the programs for fiscal years 2023 to 2027. Read More