Drugs
FDA has published a draft guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. The document also describes the agency’s process
Drugs
FDA has delayed the 12/23/22 PDUFA action date for the Junshi Biosciences and Coherus BLA for toripalimab to treat recurrent or metastatic nasopharyngeal carcinoma (NPC). The companies say FDA previously communicated that an on-site inspection of the Junshi Biosciences manufacturing facility for toripalimab is required before the
Drugs
FDA has released the form FDA-483 issued following a 5/12-5/20/22 inspection at the Glenmark Pharmaceuticals drug manufacturing facility in Goa, India. The five inspection observations were: * failing to extend investigations of an unexplained discrepancy and a failure of a batch or any of its components
Drugs
FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer, or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib). A
Drugs
BIO, the Biotechnology Innovation Organization, says FDA should clarify flexibility around what tools may be used under an FDA draft guidance on measuring growth and evaluating pubertal development in pediatric clinical trials. In its comment letter, BIO says the draft could be interpreted to be prescriptive on which tools should
Drugs
FDA has accepted for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second
Drugs
Lupin Pharmaceuticals recalled 12/21/22 four lots of Quinapril 20 mg (one lot) and 40 mg (three lots) tablets due to the potential presence of N-Nitroso-Quinapril impurity. FDA published the company announcement that said that to date the company has received no reports of illness that appeared
Drugs
FDA has approved Genentech’s Lunsumio (mosunetuzumab-axgb), described as a first-in-class bispecific antibody, to treat patients with relapsed or refractory follicular lymphoma. The company says that results from a pivotal Phase 2 trial demonstrated that 80% of patients who received at least two prior therapies achieved durable
Drugs
FDA has approved Gilead’s Sunlenca (lenacapavir), described as a new type of antiretroviral medication for adult patients with human immunodeficiency virus type 1 (HIV-1) whose infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. An agency announcement says that after the
Drugs
FDA has published a REMS Document Technical Conformance Guide to supplement a guidance on the Format and Content of a REMS Document. The conformance guide provides technical recommendations to applicants to draft a REMS. It is intended to complement and promote interactions between applicants and FDA. However, it says, it
Drugs
Checkpoint Therapeutics has submitted a BLA for cosibelimab, an investigational anti-PD-L1 antibody for treating patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation. The submission is based on clinical trial data showing that cosibelimab-treated patients
Drugs
FDA says it will not act on the Phathom Pharmaceuticals NDA for vonoprazan as a treatment for erosive esophagitis on or before the 1/11 PDUFA action date. Phathom says the delay comes after the company reported on 8/2/22 it had detected trace levels of N-nitroso-venoprazan
Drugs
As FDA prepares to render an accelerated approval decision this week on an Eisai and Biogen BLA for lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for treating Alzheimer’s disease, health/medicine journalist Joanne Silberner reminds readers in a 1/4 The Free Press article about how little
Drugs
FDA has published a guidance, Format and Content of a REMS Document, with recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product. The document provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS
Drugs
FDA has posted the 7-9/2022 potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System. The list contains 16 listings involving 37 drug products. For 14 of the 16, the agency says it is evaluating the need for regulatory action. For the
Drugs
Major drug companies are expected to raise prices on more than 350 drugs early this month, according to a Reuters exclusive report. The news service says that in 2022 drug companies raised prices on more than 1,400 drugs, with a median increase of 4.9% and an average increase
Drugs
CDER researchers say that while the use of single-arm oncology trials has allowed for transformative oncology therapies to be made available to patients expeditiously, using such trials to support drug approval presents several challenges that must be carefully considered. Writing in JAMA Oncology, the researchers say that between 1/
Drugs
The Federal Trade Commission (FTC) has released its new “FTC Health-Related Advertising Guide” that covers more stringent compliance factors than previously expected that industry should consider before publishing health product marketing (online or offline) advertisements. Attorney Phyllis Marcus (Hunton Andrews Kurth) writes in an online post that the FTC
Drugs
A 4/25-5/9/22 FDA inspection at MD Pharmaceutical Supply, in Hanover, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A just-released 11/22/22 Warning Letter says specific deviations were: * failing to adequately investigate and document complaints or any
Drugs
A 9/21/21-11/4/21 FDA inspection at the Plattsburgh, NY, drug outsourcing facility acquired by Sagent Pharmaceuticals identified serious deficiencies in the firm’s practices for producing drug products intended to be sterile. A just-released 7/27/22 Warning Letter says violations of the Federal Food,
Drugs
FDA has modified the mifepristone REMS program to allow Mifeprex (commonly referred to as an abortion drug) and its approved generic to be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. An agency question-and-answer notice says the change was made in response
Drugs
FDA says Accord Healthcare recalled daptomycin for injection 500 mg/vial and daptomycin for injection 350 mg/vial in one lot due to a labeling mix-up. An agency notice says the recall came after the company received a complaint from a hospital pharmacy that labels were found misapplied to