Drugs
Celgene has discontinued its Phase 3 REVOLVE trial (CD-002) in Crohn’s disease and the extension trial (SUSTAIN, CD-004) that are both studying GED-0301 (mongersen), an investigational oral antisense therapy. The company stopped the trials following a recent recommendation from its data monitoring committee, “which assessed overall
Drugs
FDA has posted an internal policy and procedures document entitled “CMC Reviews of Type III DMFs for Packaging Materials.” The document establishes standardized policy within the Office of Pharmaceutical Quality for chemistry, manufacturing, and controls governing the review of information regarding certain packaging materials in Type III drug master files
Drugs
FDA has released the FDA-483 issued following an 8/15-9/26 agency inspection at Atlas Pharmaceuticals, a Phoenix, AZ, outsourcing facility. The 15 inspection observations were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 16-0 to recommend approval of Novo Nordisk’s once-weekly semaglutide to improve glycemic control in adults with Type 2 diabetes. In a briefing document released in advance of the meeting, agency reviewers said the indication of semaglutide as
Drugs
A New York federal court has granted a motion from Quincy Bioscience and related organizations and individuals seeking dismissal of a Federal Trade Commission (FTC) suit alleging that the company made false and unsubstantiated claims that its Prevagen dietary supplement improved memory. Attorney Riëtte van Laack (Hyman, Phelps & McNamara)
Drugs
FDA has approved Nexus Pharmaceuticals’ procainamide HCl injection as a multi dose vial containing 1,000 mg per 2 mL (500 mg/mL) or as a multi dose vial containing 1,000 mg per 10 mL (100 mg/mL). The AP-rated generic equivalent is intended to address a current
Drugs
A Massachusetts federal court has ruled that a putative class action suit against a group of drug companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye can absorb is preempted by federal law. Attorney Michelle Yeary (Dechert) writes in an online
Drugs
Merck says that its Carlsbad, CA, manufacturing facility to produce BioReliance viral and gene therapy products has completed and passed both an FDA and a European Medicines Agency inspection. A company statement says the Carlsbad facility provides contract development and manufacturing services that can contribute to a more efficient delivery
Drugs
FDA has approved a Kite Pharma NDA for Yescarta (axicabtagene ciloleucel), a cell-based gene therapy for treating adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. The chimeric antigen receptor (CAR)
Drugs
FDA has granted Pluristem Therapeutics an orphan drug designation for its PLX-R18 cell therapy for preventing and treating acute radiation syndrome (ARS). Pluristem recently reported positive data from non-human primates (NHPs) studies of PLX-R18 cells as a treatment for ARS conducted by the National Institute of Allergy
Drugs
Public Citizen says that if former Lilly USA president Alex Azar is named HHS secretary as has been rumored in the media, “Big Pharma’s coup d’etat in the healthcare sphere will be virtually complete.” The advocacy group says that Azar has made public statements indicating that he opposes
Drugs
After 28 years at FDA, CDER Office of Process and Facilities (OPF) acting deputy director David Doleski is leaving next month to accept the position of biologics compliance head at Sanofi Genzyme. At OPF, which is part of the Office of Pharmaceutical Quality (OPQ), Doleski had responsibility for integrating inspection
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. The submission is based on the positive results
Drugs
FDA has released two identical FDA-483s issued 4/26 and 5/3 following a 4/20-4/26 agency inspection at Akorn, Inc., Decatur, IL. The inspection observations were: * the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed; * equipment used in
Drugs
FDA has accepted a Pacira Pharmaceuticals supplemental NDA resubmission seeking expansion of its Exparel (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. The agency has set a user fee review action target date of 4/5/2018. Exparel is currently indicated for single-
Drugs
FDA has released the FDA-483 issued following a 2/20-3/24 inspection at Pfizer’s Meridian Medical Technologies combination drug/device manufacturer, whose products include the EpiPen, in Brentwood, MO. The 14 inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch
Drugs
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for treating patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. Currently, the standard of care for these patients with locally advanced (Stage 3) lung cancer
Drugs
CDER Office of Generic Drugs director Kathleen Uhl and Office of Pharmaceutical Quality director Michael Kopcha say the recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) is a “victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at
Drugs
The International Council for Harmonization (ICH) says it has adopted a new guidance relating to clinical trials in children that complements one from 2000. The new document, it says in a news release, addresses new scientific and technical knowledge advances in pediatric drug development and updates certain aspects of the
Drugs
Teva Pharmaceutical Industries has submitted a BLA for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for preventing migraine headaches. The submission is based on data from Phase 3 studies that “demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in
Drugs
Three Gibson, Dunn & Crutcher attorneys write in a WLF Legal Pulse published by Washington Legal Foundation that a Federal Trade Commission (FTC) suit against Shire is the latest development in the FTC’s well-established program for enforcing antitrust laws where it feels generic competition is being blocked or
Drugs
A Kentucky federal judge has dismissed six of seven allegations in a suit against Zydus Pharmaceuticals, a manufacturer of a generic form of Wyeth’s Cordarone (amiodarone hydrochloride). The suit’s plaintiff says she suffered blindness due to amiopdarone toxicity after taking the drug to treat atrial fibrillation, an off-