Drugs
FDA has issued a complete response letter to Gilead Sciences for its NDA for filgotinib to treat moderately to severely active rheumatoid arthritis. The company says the agency requested data from the MANTA and MANTA RAy studies before completing the NDA review. It says the studies are intended to assess
Drugs
FDA has issued an 8/18 complete response letter to BioMarin Pharmaceutical for its valoctocogene roxaparvovec gene therapy for severe hemophilia A. The company says the agency is now requesting two years of data from the ongoing Phase 3 study to provide evidence of a durable effect using annualized bleeding
Drugs
FDA has issued an immediately-in-effect guidance, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency Questions and Answers, to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for
Drugs
CBER has issued a Manual of Policies and Procedures (MAPP), Consolidation of ANDAs by the Office of Generic Drugs, describing the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted by an ANDA applicant. The MAPP applies to the Office of Generic Drugs (OGD) ANDA
Drugs
FDA says Oxford Medical Instruments USA, Carlsbad, CA, is selling through a Web site salt inhaler products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. An 8/11 Warning Letter says the agency has determined that the products are misbranded unapproved new drugs. “We request that
Drugs
FDA has issued a guidance, Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.28(c), related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence
Drugs
FDA says a Web site and Facebook page operated by SilveryGuy from Singapore is selling unapproved and misbranded colloidal silver representing or implying that the product can mitigate, prevent, treat, diagnose, or cure Covid-19 in people. An 8/14 Warning Letter gives several of the Web site and social
Drugs
CDER has issued a Manual of Policies and Procedures, Notifying Applicants of Sentinel Analyses and Results, describing the policies and procedures followed by the Office of Surveillance and Epidemiology for notifying an applicant or holder of an NDA or BLA about certain types of safety studies conducted in the Sentinel
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. AkivaMed, U.S. (7/23): FDA recently reviewed the company’s Web site (www.akivamed.com) and determined that its “Covid-19 Antibody Rapid Test Kit” marketed to consumers
Drugs
The federal government has filed a False Claims Act complaint charging that Teva illegally paid Medicare co-pays for the multiple sclerosis drug Copaxone through purportedly independent foundations that were used as conduits in violation of the anti-kickback law. The Department of Justice (DoJ) says the company used the
Drugs
FDA has granted AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen for treating approved indications for non-small cell lung cancer (NSCLC) and bladder cancer. If approved, the drug could be administered intravenously every four weeks at a fixed
Drugs
FDA has placed a clinical hold on a Poseida Therapeutics Phase 1 clinical trial for its P-PSMA-101 in metastatic castrate-resistant prostate cancer. In a Securities and Exchange Commission notice, the company says it paused enrollment in the trial to investigate a patient's death. The notice
Drugs
President Trump reportedly has turned some attention to an extract from the oleander plant as an unproven cure for Covid-19, and he may be quietly urging FDA to help get the product on the market as a dietary supplement or a new drug, according to a report from Axios.
Drugs
FDA has accepted for review a Myovant Sciences NDA for its once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for treating women with heavy menstrual bleeding associated with uterine fibroids. The agency has set a user fee review action
Drugs
FDA has approved a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – those who are anti-aquaporin-4 antibody-positive. NMOSD is a central nervous system rare autoimmune disease that largely affects the optic nerves and spinal cord. “In
Drugs
FDA has issued a final guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how it will identify
Drugs
CDER researchers say that although pain intensity has been the primary outcome measure in clinical trials for pain, an array of measures assessing clinical outcomes from multiple perspectives can allow for a more comprehensive interpretation of how a treatment affects patients’ lives. Writing in Neurotherapeutics, the researchers say that careful
Drugs
FDA is asking the United States Pharmacopeia (USP) not to reach any conclusion on including disregard limits/drug thresholds in drug substance and drug product monographs as proposed by the USP 8/13/19. A just-released FDA 7/31 comment letter gives the agency’s rationale and reasons for
Drugs
FDA has accepted a Novartis supplemental BLA for a new self-administration option for Xolair (omalizumab), which is designed to target and block immunoglobulin E (IgE) for treating patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria. Currently, the therapy is approved only for administration by a
Drugs
FDA has accepted a TG Therapeutics NDA for umbralisib, a once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma who have received at least one prior anti-CD20 based regimen and patients with follicular lymphoma who have received at
Drugs
FDA has made available a draft guidance entitled “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.” The document is intended to assist sponsors in the clinical development of drugs and biological products for treating AML. It includes the agency’s current thinking on the overall development program and
Drugs
FDA has granted accelerated approval to NS Pharma’s Viltepso (viltolarsen) to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. An agency announcement says this is the second approved targeted treatment for patients with this