Drugs
Cipla’s InvaGen Pharmaceuticals unit has recalled one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues that could allow powder leakage from the pouch. “An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower
Drugs
People for the Ethical Treatment of Animals (PETA) is urging FDA to move away from animal experiments in its laboratories and to use more non-animal, human-relevant research methods. In a 12/11 letter to FDA commissioner Robert Califf, PETA highlights what it calls numerous “egregious violations of animal
Drugs
Novartis says updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial reinforce an earlier benefit seen in an interim analysis — a 25.1% reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early
Drugs
FDA has issued a guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document describes FDA’s interpretation of the requirements of the Act and it provides recommendations for robust verification systems for the determination, quarantine and investigation of suspect products, as well
Drugs
FDA says it does not intend to take regulatory action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not on the Section 503B bulks list if the drug (1) appeared on the agency’s drug shortage list within 60 days of distribution
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
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
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
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
Drugs
FDA says its review of a Web site maintained by Belmont Eyecare in Chicago, IL, determined that the site offers six types of eye drops for sale in the U.S. that are unapproved new drugs that are being marketed illegally. A 12/1 Warning Letter says the products are
Drugs
Lilly says results of the MONARCH trial of its Verzenio (abemaciclib) plus an aromatase inhibitor (AI) compared to an AI alone had positive results in HR+, HER2- advanced or metastatic breast cancer. A company statement says that at eight years of follow-up, MONARCH showed women taking the Verzenio and
Biologics
A panel presentation at the 2023 AFDO/RAPS Healthcare Products Collaborative stressed the positive role FDA Project Jurisdiction Officers (PJO) play in coordinating the consideration of combination products. “The PJO is your best contact if you know, or think you know, your product’s Center or if you already have