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Teva Pharmaceuticals and Allergan will pay more than $161 million to the state of West Virginia to settle allegations that the companies contributed to the opioid epidemic. Read More
Sens. Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) introduced a bill this week that directs the Federal Trade Commission (FTC) to hold pharmacy benefit managers (PBM) accountable for allegedly deceptive pricing practices that raise the costs of prescription drugs. Read More
In an effort to get more gonadotropin-releasing hormone (GnRH) analogues to market for advanced prostate cancer patients, the FDA has published final guidance with recommendations spanning the full spectrum of development, including clinical trial design. Read More
Oncology research and drug development continue to surge globally, with 159 new medications launched since 2012 — and a record 30 of those in 2021 — according to the life science research analytics firm IQVIA Institute. Read More
“We are holding pharmaceutical companies accountable and working with them to offer more affordable medication,” said New York State Senate Majority Leader Andrea Stewart-Cousins (D). Read More
To help support a global approach to developing new drugs that address antimicrobial resistance (AMR), the European Medicines Agency (EMA) has published a final guideline aimed at aligning data requirements with other countries to meet multiple regulators’ needs. Read More
To help small entities follow its 2020 final rule on importing prescription drugs from Canada, the FDA released a compliance guide yesterday explaining that U.S. importation programs must show “significant cost reductions” of the products to American consumers. Read More
A federal judge in Delaware has ended an attempt by Gilead Sciences to defend its Lexiscan (regadenoson) cardiac stress agent from generic competition. Read More
In an unusual legal action, Vanda Pharmaceuticals is suing the FDA in a federal court for denying a request for Fast-Track designation for its investigational drug tradipitant after a series of failed attempts using other regulatory pathways. Read More