Archive for May 2022
Form 483 Docks Clinical Formula for Inadequate Quality and Laboratory Controls
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. Source: Drug Industry Daily
Read MoreFDA Issues Final Guidance on Developing GnRH Analogues for Advanced Prostate Cancer
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. Source: Drug Industry Daily
Read MoreSurging Oncology Research Yields Big Approval Dividends and Lucrative Payoffs, Study Says
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. Source: Drug Industry Daily
Read MoreEMA Publishes Revised Guideline on Evaluating Antibacterial Drugs
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. Source: Drug Industry Daily
Read MoreFDA Issues ‘Small Entity’ Guidance for Importing Prescription Drugs From Canada
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. Source: Drug Industry Daily
Read MoreVerrica Draws Second Complete Response Letter for Manufacturing Deficiencies
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. Source: Drug Industry Daily
Read MoreBlockbusters, Accelerated Approval Drugs Get Most FDA-Cleared Formulations
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. Source: Drug Industry Daily
Read MoreNirogacestat, SpringWorks’ Gamma Secretase Inhibitor, Scores in Phase 3 Desmoid Tumor Trial
SpringWorks unveiled some good news this week with positive topline data supporting its investigational antitumor drug nirogacestat in patients with progressing desmoid tumors. Source: Drug Industry Daily
Read MoreFederal Judge Rules Against Gilead in Lexiscan Generic Case
A federal judge in Delaware has ended an attempt by Gilead Sciences to defend its Lexiscan (regadenoson) cardiac stress agent from generic competition. Source: Drug Industry Daily
Read MoreVanda Sues FDA for ‘Capricious’ Denial of Fast-Track Status
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. Source: Drug Industry Daily
Read More