Drugs
A 9/12-9/19/22 FDA inspection at Cornea Associates of Texas, in Dallas, TX, found “objectionable conditions” in the facility’s role as the sponsor and Dr. Tyrone McCall’s role as the authorized representative of the sponsor and clinical investigator for two clinical investigations. A 3/22
Drugs
Merck says it will meet with regulatory authorities about an expanded indication after reporting results from the Phase 3 NRG‑GY018 trial of its anti-PD-1 therapy Keytruda being evaluated in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks
Drugs
The chairs of the House Energy and Commerce Committee and its subcommittees on health and oversight and investigations are asking FDA commissioner Robert Califf for detailed information on drug shortages. In a 3/27 letter, the committee leaders said, “FDA states that it monitors ongoing drug shortages and works closely
Drugs
GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from its RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients
Drugs
FDA says it has approved labeling changes for vismodegib (Genentech’s Erivedge) and glasdegib maleate (Pfizer’s Daurismo) to include information on musculoskeletal adverse reactions and recommendations to obtain baseline serum creatine kinase (CK) and monitoring of CK levels. The announcement of the labeling changes is in the agency’s
Drugs
FDA says that it is now resuming in-person face-to-face (FTF) meetings with generic drug industry members in a “phased-in approach” while also allowing the option to hold a videoconference meeting. “Initially, the in-person FTF meeting option will only be available for pre-ANDA product development
Drugs
Oncology drug developers are encouraged to focus on randomized clinical trials, according to FDA recommendations in a 3/24 draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.” FDA Oncology Center of Excellence director Richard Pazdur is quoted in a release as saying: “Building quality and
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote prescription drugs. “The FDA takes its responsibilities seriously and will continue to monitor promotion and communications regarding prescription drugs through its surveillance operations, which include online platforms,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says a recent FDA draft guidance on oncologic drug development provides limited information on how to optimize the dosage for oncology products that are developed for use in combination with other oncology therapies. In comments to FDA on its draft “Optimizing the Dosage
Drugs
FDA has issued Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating certain types of myelofibrosis, polycythemia vera and graft-versus-host disease. Jakafi is currently approved in a twice-daily dosage. “The complete response letter states that
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee 3/22 voted 9 to 0 that Biogen’s amyotrophic lateral sclerosis (ALS) drug tofersen should be considered for accelerated approval. Panel members agreed that a biomarker assessed in tofersen’s clinical trial — a reduction in plasma neurofilament light chain
Drugs
FDA has published a framework that it says it will use to implement a multifaceted digital health technologies (DHT) program for drugs. The document notes that the PDUFA 7 commitment letter stating the agreements between the agency and industry for reauthorization of PDUFA, included goals relating to using DHTs to
Drugs
Regeneron and Sanofi say a Phase 3 trial of Dupixent (dupilumab) evaluating the investigational use of the drug compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation met all key primary and secondary
Drugs
FDA has approved a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasis in adults with limited or no alternative treatment options. The companies say this is the first new treatment option approved for these conditions in over a decade. Approval was
Drugs
FDA has issued AbbVie a complete response letter for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. The agency letter requested additional information about the product’s device (pump), the company says, adding that there were no requests to conduct additional efficacy and
Drugs
FDA says its review of the Procter & Gamble drug listing information for its Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion determined that there is contradictory information between the labeling and the electronic listing file. A 3/14 Warning Letter refers the company to a 10/31/
Drugs
FDA has granted Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr), a monoclonal antibody targeting programmed death receptor-1 (PD-1) for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Approval was based on tumor response rate and duration of response (DOR), according to
Drugs
A Senate Homeland Security & Governmental Affairs Committee majority staff report, “Short Supply: The Health and National Security Risks of Drug Shortages,” lists six steps FDA, Congress, and others can take to help address the significant problem of drug shortages. The report notes that between 2021 and 2022, new drug
Drugs
In comments to the White House Office of Science and Technology Policy (OSTP), Pharmaceutical Research and Manufacturers of America (PhRMA) presents three ways to increase diversity in clinical trials. PhRMA says OSTP solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials. The trade association says it shares
Drugs
The Federal Trade Commission (FTC) says the Delaware federal court should consider the antitrust implications in deciding whether to grant a Supurnus Pharmaceuticals motion to dismiss a generic Apokyn (apomorphine) case brought by Sage Chemical and its marketing partner TruPharma. An FTC statement says that Sage and TruPharma allege that
Drugs
The International Council for Harmonization approved 3/14 a guidance, Nonclinical Biodistribution Considerations for Gene Therapy Products S12, with harmonized recommendations for the conduct of such studies. The document has recommendations for the overall design of nonclinical biodistribution assessments. Considerations for the interpretation and application of the biodistribution data to
Drugs
The Friends of Cancer Research says an FDA draft guidance on optimizing the dosage of human prescription drugs and biologic products to treat oncologic diseases “provides an essential framework to ensure patients receive drugs and biological products … at a dosage that is not only most efficacious and safe, but also