Drugs
American Gene Technologies (AGT) has submitted an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy being developed for eliminating HIV from people infected with the disease. The genetically-modified cell product is made from a person's own cells, and it
Drugs
FDA says Johnson & Johnson has recalled one lot of its Johnson’s Baby Powder (Lot #22318RB) after an agency sample detected chrysotile fibers, a type of asbestos. The sampling is part of FDA’s ongoing survey of cosmetic products for asbestos, which started in 2018. The agency says it
Drugs
FDA has approved a Teligent ANDA for Gentamicin Sulfate Cream USP, 0.1%. The drug is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). The company says the annual sales for the
Drugs
Federal Register notice: FDA has announced it is accepting invitations to participate in the Fiscal Year 2020 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Pharmaceutical companies interested in participating in this program should submit a site visit proposal to OPQ by 11/17. The program
Drugs
The Federal Trade Commission (FTC) says Nature City, Boca Raton, FL, which markets two aloe vera-based supplements, has agreed to pay $537,500 to settle charges that it deceived consumers with false and unsupported claims that its TrueAloe and AloeCran were effective treatments for a range of conditions affecting
Drugs
FDA has posted an online information sheet strongly advising women against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding. The sheet says there are many potential negative health effects from using marijuana and other products containing THC during pregnancy and while
Drugs
FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopustular rosacea in adults. The agency has set a user fee review action target date of 6/2/2020. The submission is supported by data from two
Drugs
FDA has approved a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. Xofluza was approved a year
Drugs
Viatrexx Bio has recalled all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarantee their sterility. “Administration of a non-sterile product, intended to be sterile, may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 14 to 2 to recommend approval of a Shionogi NDA for cefiderocol injection for its proposed indication to treat complicated urinary tract infections (cUTI). Cefiderocol is a siderophore cephalosporin with shown activity against several gram-negative bacteria. Briefing materials released in advance
Drugs
Ipsen is asking FDA to require that any proposed generic form of its Somatuline Depot (lanreotide acetate) for subcutaneous injection be tested in vivo to assure that it is bioequivalent to the reference-listed drug (RLD). “Based on Ipsen’s many years of experience with the product,” the company petition
Drugs
Greenleaf Health says it has added good clinical practice services to its range of FDA regulatory consulting efforts. The company says its expanded good clinical practice services build on its robust compliance portfolio by working with life science entities to evaluate and strengthen clinical quality systems. The company says its
Drugs
FDA has granted Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test. The designation was based on data from multicenter prospective clinical trials that suggest that the non-invasive, blood-based IsoPSA assay has superior diagnostic accuracy when compared to traditional prostate-specific antigen
Drugs
FDA acting commissioner Ned Sharpless says the agency approved a total of 1,171 generic drugs (935 full approvals and 236 tentative approvals) in FY 2019, setting a record. In a statement, Sharpless says the approvals beat the FY 2018 record of 971 total approvals. He also said that in
Drugs
Washington Legal Foundation (WLF) says an FDA proposed rule to require photorealistic color graphics to accompany textual warnings on cigarette packs violates the First Amendment. In comments to the agency, WLF challenges the FDA claim that because a significant information gap exists, the proposed rule is necessary to inform the
Drugs
FDA has issued a guidance, Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products, with recommendations to applicants about requests for waivers, refunds, and reductions of user fees for drugs and biological products. The document revises a 9/2011 guidance. The agency says the revised
Drugs
Public Citizen says that amendments announced 10/16 to H.R. 3, the Lower Drug Costs Now Act, contain several “modest improvements,” but more still needs to be done. In a statement, Public Citizen says the amendments include allowing the government to negotiate prices for some newly launched drugs, eventually
Drugs
Eli Lilly says top-line results from the Phase 3 SEQUOIA trial evaluating its pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) show that pegilodecakin failed to meet its primary endpoint of overall survival in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line
Drugs
ViiV Healthcare has filed a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. Dovato is currently approved as a complete, once-daily, single-tablet regimen for HIV-1 in adults
Drugs
FDA has approved a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults and children six months of age and older. Approval was based on data from a trial involving 262 patients aged 18 years of age and older who presented to an emergency department
Drugs
FDA has issued a safety alert on Efficient Laboratories’ Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination risks. The agency recommends that the over-the-counter medicines not be used because they could cause illness. The alert says that the agency 10/9 urged the
Drugs
FDA drug reviewers appear to be focused on mortality concerns with a Shionogi NDA for cefiderocol injection that heads to an advisory committee vote 10/16 for its proposed indication to treat complicated urinary tract infections (cUTI). According to just-posted briefing materials, the agency aims to have a discussion