Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete resection. Approval is based on results from the EORTC1325/KEYNOTE-054 trial, which demonstrated that Keytruda significantly prolonged recurrence-free survival. It was also shown to reduce the
Drugs
An Arizona federal judge has rejected a Goldwater Institute effort to force FDA to publicly describe how dying people can get access to unapproved medicines. The Arizona Daily Star reports that judge Susan Bolton said attorney Jonathan Riches has no legal right to force the agency to disclose how it
Drugs
FDA has accepted a Clearside Biomedical 505(b)(2) NDA for Xipere (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection for treating macular edema associated with uveitis. The agency has set a 10/19 user fee review action target date. The submission is supported by data from the Phase 3 PEACHTREE
Devices
FDA has cleared a Royal Philips 510(k) for the DigitalDiagnost C90, its newest digital radiography system. The device is designed to increase patient throughput and decrease the time to diagnosis, the company says. DigitalDiagnost is described by Royal Philips as the industry’s first radiography unit with a live
FDA Policy/General
Federal Register notice: FDA has issued a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Food, Drug, and Cosmetic Act. The agency is placing six bulk drug
Drugs
FDA and Arca Biopharma have reached agreement on a special protocol assessment (SPA) for the PRECISION-AF Phase 3 clinical trial to assess the safety and efficacy of Gencaro (bucindolol HCl) as a genetically-targeted treatment for atrial fibrillation in patients with a specific type of heart failure (those with
Drugs
The Federal Trade Commission (FTC) says it has reached a global settlement with subsidiaries of Teva Pharmaceuticals to prohibit the company from engaging in reverse-payment patent settlement agreements that impede consumer access to generic drugs. The settlement has to be approved by three federal courts in which FTC has
Drugs
FDA has accepted for priority review an AbbVie NDA for upadacitinib and its use in treating adult patients with moderate to severe rheumatoid arthritis. The investigational once-daily oral JAK1-selective inhibitor is being studied for multiple immune-mediated diseases. The company expects a review decision in the third quarter.
Drugs
FDA has released the FDA-483 issued following a 1/30-2/8 inspection at Dr. Reddy’s Laboratories’ drug manufacturing facility in Telangana, India. The form contains 11 inspection observations, several of which are repeated from 2015 and/or 2017 inspections. The observations were: * procedures describing the handling of
Drugs
FDA has released a draft guidance, Competitive Generic Therapies, describing the process that applicants should follow to request designation of a drug as a competitive generic therapy with inadequate generic competition under the FDA Reauthorization Act of 2017. The document includes the criteria for designating a drug as a competitive
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The document describes FDA’s proposed approach for providing nonbinding feedback, including the procedures for requesting it and FDA’s review of such requests. To view the notice, click here.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Competitive Generic Therapies” that is intended to help expedite the development and review of certain ANDAs citing reference products that have inadequate generic competition. The document provides a description of the process that applicants should follow to request designation
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The document describes the expedited programs available to sponsors developing regenerative medicine therapy for serious or life-threatening diseases or conditions. It also describes considerations in the clinical development of
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (RMAT)” that provides the agency’s current thinking about how it intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products. It
Devices
Pharmaceutical Research and Manufacturers of America has given FDA four points to consider when revising its draft guidance on developing and labeling in vitro companion diagnostic devices for a specific group or class of oncology therapeutic products. The association says that: * any final guidance should clarify that class labeling is
Drugs
An FDA safety alert is warning consumers about establishments in several states that are offering young-donor plasma infusions to treat various conditions. “The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic
Biologics
FDA has approved a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A. The therapy is indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Approval is based
Devices
The federal government has intervened in a False Claims Act case alleging that Alere’s Arriva Medical unit submitted or caused false claims to be submitted to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment waivers. The
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says although there has been recent progress in risk stratification in hormone receptor-positive breast cancer, there is a need for more sophisticated prognostic-biomarker testing to identify high-risk patients in time to intervene and improve outcomes. Writing in the New
Drugs
FDA has released the FDA-483 containing two observations from a 1/28-2/8 inspection at Lupin Limited, a Goa, India, drug product manufacturer. The observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
Researchers who examined the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products and surveyed providers, pharmacists, and patients say that while there generally was adequate knowledge about using TIRFs, some survey items and claims-based analyses indicated substantial rates of inappropriate use. A Journal of
Devices
FDA has granted Medtronic a breakthrough device designation for its investigational Personalized Closed Loop (PCL) insulin pump system. The company says the PCL technology is designed to automate insulin delivery in real-time, personalized and by adapting to the user. The system is also being designed to provide insights and