Drugs
The ALS Association (ALSA) says FDA should follow its guidance and emulate the urgency shown by Health Canada and the European Medicines Agency to work with Amylyx to move its AMX0035 treatment toward approval. The association says AMX0035 “is a clinically safe drug that slowed disease progression and increased survival.
Drugs
FDA granted accelerated approval 4/13 to Immunomedics’ Trodelvy (sacituzumab and govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. An agency notice says Trodelvy’s safety and efficacy
Drugs
FDA has published an immediately effective guidance describing how the agency will request and conduct remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic
Drugs
At a meeting with CorMedix and its DefenCath (taurolidine/heparin catheter lock solution) third-party manufacturer, FDA and the firm agreed to a protocol for a manual extraction study identified in a complete response letter the agency had issued. The agency is requiring the study as confirmation of in-process
Drugs
FDA says its inspection of records supplied at the agency’s request by Proquimes SA Productos Quimicos Especializados, a registered manufacturer of active pharmaceutical ingredients (API) located in Cali, Colombia, identified significant deviations from current good manufacturing practice (CGMP) for APIs. A 4/5 Warning Letter says specific deviations were:
Drugs
Public Citizen is petitioning FDA to add all drug products containing lorcaserin HCl and all parenteral drug products containing bacitracin to the list of drugs that may not be compounded after being withdrawn from the market for reasons of safety or effectiveness. The advocacy group’s 4/13 petition also
Drugs
Braintree is petitioning FDA not to approve under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act any NDA or ANDA for a tablet-based or tablet-containing colonoscopy preparation unless it contains a specification ensuring that the tablet formulation will not inhibit or interfere
Drugs
The 5th Circuit Court of Appeals says the Federal Trade Commission (FTC) did not commit any legal errors and had sufficient substantial evidence to support its factual finding that Impax Laboratories violated antitrust law by accepting payments from Endo worth more than $100 million to delay the entry of its
Drugs
FDA 4/1 issued a Warning Letter to Maison Terre after conducting testing on its drug product labeled as “Goldenseal Root Powder Organic” and determining the repackaged product was prepared, packed, or held under insanitary conditions. The letter said the agency was aware of a report of one infant death
Drugs
Attorney Andrew Goldfarb (Zuckerman Spaeder) says the Senate approved 3/11 S. 415, a bill that would amend the Federal Food, Drug, and Cosmetic Act to replace the phrase “active ingredient (including any ester or salt of the active ingredient)” with FDA’s regulatory definition of “active moiety.” Goldfarb writes
Drugs
FDA acting commissioner Janet Woodcock has announced that CDER deputy director for operations Patrizia Cavazzoni has been appointed to her former position as CDER director, a post that Cavazzoni has served in an acting capacity for the past year while Woodcock was on detail at Operation WarpSpeed. Cavazzoni has more
Drugs
FDA has told Iterum Therapeutics that it needs more time to review company-submitted “materials” related to the ongoing NDA review for (XXX DELETE sulopenem etzadroxil/probenecid for treating uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. A previously scheduled 6/2 Antimicrobial Drugs Advisory Committee
Drugs
Bristol Myers Squibb says there were positive topline results in the Phase 3 CheckMate-648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma. A company statement says that in the study Opdivo demonstrated a
FDA Policy/General
FDA and the Federal Trade Commission say their review of Web sites and social media sites maintained by Allure Imports, Sault Sainte Marie, MI, established that the company markets products that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans or animals. A 4/7 Warning
Drugs
National Institute on Aging (NIA) researchers are looking into whether drugs already approved by FDA for indications other than dementia can be used to help prevent or treat Alzheimer’s disease. An NIA statement says the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study research team has identified a
Drugs
In what some industry observers say may be a sign that FDA is ramping up foreign inspections after a year-long hiatus due to the Covid-19 pandemic, WuXi Biologics says it successfully completed both an FDA pre-license inspection and a routine FDA GMP (good manufacturing practice) inspection at
Drugs
Ongoing FDA safety concerns with JAK inhibitors are causing review extensions for Eli Lilly/Incyte and Pfizer submissions. The drug class concerns arose from an FDA-required safety study when Pfizer’s Xeljanz (tofacitinib) was approved in 2012 for rheumatoid arthritis. In 2/2019 and 7/2019, FDA warned that
Biologics
FDA has recommended an early termination for a ERC-USA and University of California, Irvine, Phase 2 trial of ERC 1671 (Gliovac or Sitoiganap) for treating glioblastoma and recommended that the parties pursue a confirmatory Phase 3 registration trial to support a BLA application. ERC-USA says the agency advice
Drugs
FDA has approved a new dosage regimen — 120-minute intravenous infusion every two weeks — for Imclone’s Erbitux (cetuximab) for treating patients with K-Ras wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck. This dosage option is in addition to the previously approved
Drugs
Qmart (Elmwood Park, NJ) has recalled all lots of its Imperial Gold 2000, PremierZen Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 after an FDA analysis found the products to be tainted with undeclared sildenafil and/or tadalafil, which are ingredients known as phosphodiesterase (PDE-5) inhibitors found
Drugs
The FDA Cardiovascular and Renal Drug Advisory Committee will consider a FibroGen NDA for roxadustat to treat anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients on 7/15. The company says its NDA is supported by positive results from a global Phase 3 program
Drugs
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Curex, Inc., New York, NY, determined that the firm markets mixtures of allergenic extracts intended for sublingual immunotherapy. A 3/23 Notice of Violation says the Web site refers to the products as