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
Devices
Roche and Eli Lilly are collaborating to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), a blood test designed for making earlier diagnoses of Alzheimer’s disease. “If approved, the EAPP test would be an additional tool to identify low likelihood of amyloid pathology in symptomatic patients and determine whether
Biologics
CBER says there were 15,010 biological product deviation reports submitted in FY 2022, a 3% increase over the FY 2021 total of 14,556 reports. The Center’s FY 22 annual summary says the total number of reporting establishments increased from 2,152 in FY 21 to 2,276
FDA Policy/General
New University of Colorado Boulder research indicates a need for regulators like FDA and the Federal Trade Commission (FTC) to do more to keep up with social media patient influencers. The research was based on in-depth interviews with 26 so-called “micro-influencers,” who generally have between 1,000
Biologics
FDA has approved an expanded indication for Regeneron Pharmaceuticals’ Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The therapy was originally approved 2/2021 as an adjunct to other lipid-lowering therapies in those
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
Biologics
FDA has approved a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvie’s Humira, indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. The original Hyrimoz BLA was approved in 2018. With
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
Drugs
An 8/29-9/2/22 FDA inspection at the drug manufacturing facility maintained by Dunagin Pharmaceuticals, doing business as Massco Dental, in Rogers, AR, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/22 Warning Letter says specific violations were: * failing
Drugs
A 9/6-9/20/22 FDA inspection at the Cosmetic Science Laboratories drug manufacturing facility in Torrance, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/10 Warning Letter says specific violations were: * failing to conduct at least one test to verify
Biologics
Speaking on 3/20 to the 2023 Muscular Dystrophy Association Clinical and Scientific Conference, CBER director Peter Marks discussed three ways FDA is working to overcome barriers to developing gene therapies for rare diseases. In a video summary of his keynote address posted by Neurology Live, Marks said FDA is
Drugs
CDER is making several requests if FDA chief scientist Namandjé Bumpus grants an Intarcia Therapeutics 2/21 petition seeking a public hearing before the FDA Endocrinologic and Metabolic Drugs Advisory Committee on the Center’s refusal to approve an Intarcia NDA for its ITCA 650 (exenatide in DUROS device). Intarcia
Drugs
Karuna Therapeutics is planning a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from its Phase 3 EMERGENT-3 trial evaluating the drug's (XXXX INSERT XXX)efficacy, safety (XXX DELETE COMMA XXXX)and tolerability. (XXXX DELETE XXX) “The trial met its primary
FDA Policy/General
Researchers from FDA and RTI International say that as empirical research on prescription drug promotion to consumers and healthcare providers has accelerated, an understanding of the current landscape of the activity will help inform future research. Writing in Research in Social and Administrative Pharmacy, the researchers say their rigorous scoping
Devices
FDA has cleared a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence (AI) tool for stroke diagnoses. The device is a collection of tools that use AI algorithms to support doctors by providing real time interpretation of brain scans to help guide treatment and transfer decisions for
Devices
FDA has cleared a Viz.ai 510(k) for its Viz AAA, an artificial intelligence (AI) algorithm intended to detect suspected abdominal aortic aneurysms (AAA). The device uses AI to automatically search for the presence of an abdominal aortic aneurysm from computed tomography angiography from any scanner in a hospital
Devices
CDRH is adding more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process. Beginning 10/1, all 510(k) submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent supplements and amendments will be required to be submitted in
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says rare disease drug development could benefit by FDA providing greater detail and context on the types of evidence that may be considered confirmatory. In comments on rare disease development, the industry group says that because many rare diseases do not have relevant
Devices
Medical Device Manufacturers Association (MDMA) says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evidence (RWD/RWE) activities with any new organizations. Responding to a request for comments, MDMA president Mark Leahy recommends that FDA and industry continue to develop