Drugs
Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) reintroduced 12/5 their Affordable Drug Manufacturing Act to authorize generic drug manufacturing in HHS. A statement from Warren says the bill would address the skyrocketing cost of prescription drugs and increase competition in the generic drug market by
Drugs
FDA has accepted for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimer’s disease. The agency has set a 7/27 review action target date. The company describes ALPHA-1062 as a new chemical entity (acetylcholinesterase inhibitor) that has minimal gastrointestinal side effects. “ALPHA-
Drugs
Regeneron says it will submit positive Phase 1/2 trial results of its linvoseltamab in multiple myeloma to FDA and is on track to submit a BLA to the agency this year. A company statement says the primary endpoint analysis from the LINKER-MM1 trial “demonstrated high rates of deep
Drugs
Reps. Anna Eshoo (D-CA) and Michael McCaul (R-TX) introduced 12/7 the bipartisan Innovation in Pediatric Drugs Act of 2023 to “ensure drugs for rare diseases are studied in children and drug companies are accountable for completing pediatric study requirements.” A statement from Eshoo says the bill would
Drugs
Zydus Pharmaceuticals is asking FDA to “investigate and take prompt enforcement action against methylene blue injection of BPI Labs.” A 12/6 citizen petition says the BPI product currently on the market has not been evaluated by FDA for safety or efficacy. The petition says that similar products have been
Drugs
A Bausch & Lomb FDA 11/30 citizen petition asks FDA to refuse to receive and/or refuse to approve any ANDA referencing Xipere (triamcinolone acetonide injectable suspension) that uses a different SCS injector than the approved proprietary SCS Microinjector unless the ANDA includes in vivo studies with clinical endpoints
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with provisions in the Drug Supply Chain
Drugs
Merck has stopped its Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynparza (AstraZeneca’s PARP inhibitor) for treating patients with metastatic squamous non-small cell lung cancer. The decision was based on a recommendation from an independent data monitoring committee that
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for QED Therapeutics’ Truseltiq (infigratinib), indicated for treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved
Devices
A lengthy, deeply-researched article released by the investigative newsroom ProPublica and the Pittsburgh Post-Gazette faults FDA for failing to use its power to protect millions of people who were using tainted Philips Respironics CPAP machines and ventilators. While FDA maintains that it acted as soon as it learned
Drugs
FDA has published a draft guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, stating that it does not intend to take regulatory action for compounding drug products under Section 503A using a bulk drug substance when an applicable
Drugs
FDA has granted in part and denied in part a 2017 petition filed by Provepharm asking that the agency not approve any ANDA or NDA seeking approval of an injectable blue drug product unless the application contains specific information stated in the petition to show that the applicant’s drug
Drugs
FDA has approved Novartis’ Fabhalta (iptacopan) as the first oral monotherapy to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). A company statement says Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell destruction within
Drugs
Rep. Andy Harris (R-MD) says a “cozy relationship” between FDA and drug companies may be a reason the agency took 10 years to act on phenylephrine, a popular nasal decongestant that has been found to be ineffective. Speaking on the Newsmax “National Report,” Harris said, “I don’t know
Drugs
Arcutis Biotherapeutics, Inc., is petitioning FDA not to approve any ANDA for a generic form of the company’s Zoryve (roflumilast) topical cream, 0.3%, that does not take steps dictated by Arcutis to demonstrate that the proposed generic is equivalent to Zoryve. The petition says Zoryve is indicated for
Devices
FDA has opened its eSTAR electronic submission template for voluntary use for certain PMA submissions. The agency says the eSTAR interactive PDF form is intended to guide applicants through preparing a comprehensive medical device submission. “eSTAR is intended to enhance the incoming quality of submissions for a wide range of
Biologics
CBER director Peter Marks says his Center has high hopes to speed gene therapy development through the harmonization of manufacturing protocols. This effort is mainly being led by the Bespoke Gene Therapy Consortium, a partnership between NIH, FDA and various public and private organizations, and it includes pilot programs that
Biologics
FDA has accepted for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisplatin-based chemotherapy for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (bladder cancer). The agency has set a user fee review action target date of
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditionally approved new animal drug applications during July, August, and September. The regulations are also being amended to improve their accuracy and readability. To
Devices
Three medical device industry stakeholders are raising multiple concerns about an FDA draft guidance on best practices for selecting a predicate device to support a 510(k) submission. The Medical Device Manufacturers Association (MDMA) says the draft appears to reflect an evolution from the agency’s approach to the 510(
Drugs
FDA has extended by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis. The updated user fee review action target date is 3/16. Currently, Xhance is indicated for treating chronic rhinosinusitis with nasal polyps. The company says the review
Drugs
FDA’s Oncology Center of Excellence and real-world evidence company Syapse say they have renewed a four-year agreement to collaboratively develop and implement specific research projects to “advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence to