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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
The FDA issued skincare drug product developer Clinical Formula a five-observation Form 483 for lacking an effective quality control unit and other serious deficiencies observed during a November-December 2021 inspection of its Newport Beach, Calif., facility. 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
West Chester, Pa.-based Verrica Pharmaceuticals drew a second Complete Response Letter (CRL) from the FDA rejecting the company’s New Drug Application (NDA) for its investigational drug VP-102 to treat patients with the viral skin disease molluscum contagiosum. Read More
Best-selling medicines and drugs cleared under an FDA accelerated approval nab the most FDA-approved new formulations, and this translates to more costs for insurance plans and patients, according to an analysis in the journal JAMA Health Forum. Read More