Drugs
An FDA 9/11-9/14/17 inspection at Yicheng Goto Pharmaceuticals, Hubei Province, China, found significant deviations of current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 7/26 Warning Letter says the specific deviations were: * failing to adequately validate the process for cleaning
Drugs
Eastern Pennsylvania federal court has denied a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab. The 2017 suit alleges that Johnson & Johnson engaged in anticompetitive practices (exclusive agreements and bundled rebates to shield Remicade from Pfizer’s biosimilar product, Inflectra. In the
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FDA has proposed a new “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads” that is intended to research regulatory requirements for fair balance and the brief summary. Specifically, the agency wants to know if repeating warnings in the Important Safety Information (ISI) section
Drugs
FDA has accepted for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive seizures). The submission is based on data from the Phase 3
Drugs
FDA has released a new draft guidance that is intended to modernize clinical trial designs in oncology drug development. “The approach we’re describing in new guidance today is to help innovators to evaluate drugs in trials that are potentially lower cost, more efficient, and could enable us to learn
Drugs
FDA has approved an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA). “This approval is part of
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FDA has approved a Population Council NDA for Annovera (segesterone acetate and ethinyl estradiol vaginal system), the first vaginal ring contraceptive that can be used for an entire year. The reusable donut-shaped, non-biodegradable, flexible vaginal system is placed in the vagina for three weeks followed by one week
Drugs
Three FDA researchers writing in the online PLOS journal have found a significant increase in the development of new tropical disease drugs after Congress enacted the priority review voucher legislation. They note data showing increases for both high- and low- prevalence conditions. In the post-voucher period, development has centered
Drugs
FDA has outlined its planned “Complex Innovative Designs (CID) Pilot Meeting Program” that is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. Mandated in the latest user fee agreement, the program offers sponsors an opportunity to meet with CDER/CBER staff to discuss
Drugs
The American Society of Clinical Oncology and the Friends of Cancer Research have submitted to FDA recommended language for five guidance documents to broaden eligibility criteria for cancer clinical trials. The groups say (includes link to submission package) the recommendations are part of their collaboration to broaden eligibility for participating
Drugs
FDA has announced a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation” that is intended to provide a forum to discuss the current state and future directions of the collection of human data on potential skin toxicity associated with such
Drugs
The FDA Antimicrobial Drug Advisory Committee has voted to recommend to the agency that Paratek Pharmaceuticals’ intravenous and oral omadacycline is safe and effective for treating acute bacterial skin and skin structure infections and treating community-acquired bacterial pneumonia. Omadacycline is described as a modernized tetracycline being developed as a
Drugs
Federal Register notice: FDA has made available a final guidance entitled “Elemental Impurities in Drug Products.” The document provides recommendations on controlling elemental impurities consistent with recommendations in an International Council for Harmonization guidance for industry entitled “Q3D Elemental Impurities.” It is also intended to assist manufacturers on complying with
Drugs
The Stericycle Recall Index says that pharmaceutical recalls dropped 27% to 77 in the second quarter of 2018. That was lower than in six of the last eight quarters. Recalled units dropped 95% to nearly 15.9 million, lower than four of the last six quarters, the report says, but
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Insys Therapeutics has reached an agreement in principle with the Department of Justice to pay $150 million to settle a civil and criminal investigation into inappropriate sales and commercial practices by some former company employees. The agreement calls for Insys to pay the fine over five years, with the potential
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Texas attorney general Ken Paxton says that AstraZeneca has agreed to pay the state $110 million to settle suits alleging that the company falsely and misleadingly marketed Seroquel and Crestor in violation of the Texas Medicaid Fraud Prevention Act. In a statement, Paxton says the company was accused of engaging
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FDA has issued a guidance, Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances, to give manufacturers recommendations for submission of NDAs, INDs, or ANDAs, as appropriate, for orally administered immediate-release drug products that contain highly soluble drug substances.
Drugs
FDA has used its new Competitive Generic Therapy (CGT) designation to approve several strengths of Apotex’ potassium chloride oral solution. An agency statement says the CGT pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment
Drugs
A 9/25-9/27/17 inspection at Les Produits Chimiques, Quebec, Canada, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 7/24 Warning Letter says specific deviations were: * failing to perform laboratory testing of API to ensure conformance to specifications and to
Drugs
FDA has released the FDA-483 issued following a 7/9-7/17 inspection at Celltrion, an Incheon, Republic of Korea, sterile injectable drug product and drug substance manufacturer. The inspection observations were: * failing to have written procedures for production and process controls designed to assure that the drug products
Drugs
FDA has accepted for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), an investigational fixed-dose combination antihistamine/steroid nasal spray for treating seasonal allergic rhinitis in patients 12 years of age and older. The submission includes efficacy and safety results from
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FDA has approved an expanded use for Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first therapy approved to treat the underlying cause of CF in this