Drugs
FDA has accepted for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The agency has confirmed that the resubmission was a complete, Class 2 response to a 11/24/2020 complete response letter and has set a user fee review action target
Drugs
The Massachusetts federal court has granted a renewed motion for summary judgment submitted by GlaxoSmithKline to dismiss multi-district litigation alleging that the company failed to provide sufficient warning that the use of Zofran (ondansetron) by pregnant women caused birth defects in their children. The court held that state failure-
Drugs
FDA has approved a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with vulvovaginal candidiasis (vaginal yeast infection). The company says it is the first approved drug in a novel antifungal class in more than 20 years. Approval was based on data from two Phase 3 studies
Drugs
The Council for Responsible Nutrition (CRN) has petitioned FDA to reverse its recent position that the Federal Food, Drug, and Cosmetic Act prohibits manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements. “The policy, which represents a sudden and drastic departure from past agency practice, is
Drugs
The FDA Oncology Center of Excellence (OCE) has opened a “Send Your Oncology Research Questions to FDA” crowdsourcing challenge to allow interested stakeholders to submit directly to FDA staff their ideas for research using pooled analyses of oncologic clinical trial data. An online notice says agency scientists traditionally have used
Drugs
FDA has extended by three months its review of Verrica Pharmaceuticals’ NDA for VP-102 (cantharidin) for treating molluscum contagiosum, a common, highly contagious skin disease The review extension is intended to give FDA additional time to review information (major amendment) recently submitted by Verrica, including a training program and
Drugs
FDA has issued a safety communication that warns against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). “The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit
Drugs
The FDA Oncology Center of Excellence (OCE) is holding its first National Black Family Cancer Awareness Week from 6/17-6/23. “Throughout the week, the agency’s social media platforms will serve as the hub for this historic initiative as participants at healthcare centers, non-profit associations, and community
Drugs
HHS is asking the DC federal court to dismiss an 11/2020 suit filed by Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage that asked the court to block the Trump administration HHS and FDA from implementing a program to
Drugs
CDER Office of Prescription Drug Promotion (OPDP) says that as of 6/24, Form 2253 and Accelerated Approval presubmissions will only be accepted in eCTD format and may only be submitted through the electronic submission gateway. An online notice includes frequently asked questions about the process.
Drugs
FDA has issued Eton Pharmaceuticals a complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning. The company did not disclose specific concerns raised in the letter, but said all agency “questions” can be fully addressed in a response in the coming months. Eton also said
Drugs
FDA has approved Amgen’s Lumakras (sotorasib) for treating adult patients with non-small cell lung cancer whose tumors have the KRAS G12C genetic mutation and who have received at least one prior systemic therapy. “This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts
Drugs
The DC Circuit Court of Appeals has affirmed a lower court decision recognizing FDA’s authority to place homeopathic drugs on its import alert listing after determining the products were unapproved drugs. In Medinatura v. FDA, homeopathic product marketer MediNatura challenged the agency’s withdrawal of Compliance Policy Guide 7132.
Drugs
FDA has approved a Foresee Pharmaceuticals NDA for Camcevi (leuprolide mesylate) 42 mg, a six-month subcutaneous depot formulation for treating advanced prostate cancer. Approval was based on data from a Phase 3 study in 137 advanced prostate carcinoma patients. The primary efficacy end point was the percentage of subjects
Drugs
The Federal Trade Commission (FTC) has asked the Supreme Court to deny an AbbVie request that it hear its appeal of a federal district court decision that the company’s patent lawsuits against Teva and Perrigo over ANDAs for its AndroGel testosterone treatment were sham suits intended to delay generic
Drugs
A 74-year-old Georgia man who operated an Internet pharmacy on several Web sites has been sentenced to five years of probation for conspiracy to distribute unapproved drugs and unlawful smuggling of goods into the U.S. A Department of Justice statement says the sentence also included the forfeiture
Drugs
FDA has approved an emergency use authorization for a monoclonal antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in those age 12 and over. FDA said the drug, Sotrovimab, is not authorized for patients who are hospitalized due to Covid-19 or require
Drugs
Eli Lilly says it has received a subpoena from the U.S. Department of Justice requesting certain documents about its troubled manufacturing site in Branchburg, NJ. Earlier this month, an internal Lilly complaint alleged that a factory executive changed technical documents required by government regulators to downplay serious quality control
Drugs
FDA has approved Progenics Pharmaceuticals’ Pylarify (piflufolastat F 18), a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PMSA) positive lesions in men with prostate cancer. An agency notice says the approval gives certain men with prostate cancer greater access to PMSA-targeted PET imaging that
Drugs
A 3/14/19-4/5/19 FDA inspection at Metro Drugs 3rd Avenue Corp., New York, NY, found deficiencies in the company practices for producing sterile drug products, putting patients at risk. A just-released 1/8 Notice of Violation says specific violations were: * drug products intended or expected
Drugs
FDA has accepted for priority review a BLA submitted by Janssen for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen-directed chimeric antigen receptor T cell therapy being developed with Legend Biotech to treat relapsed/refractory multiple myeloma. Legend says the agency set 11/29 as the PDUFA
Drugs
FDA says it is restricting the use of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. An agency drug safety communication says some PBC patients who took Ocaliva, especially those with evidence of advanced