Drugs
FDA has accepted a Rockwell Medical NDA an intravenous formulation of Triferic (ferric pyrophosphate citrate) for patients with end-stage renal disease and chronic kidney disease. FDA has set a user fee review target action date of 3/28/2020. In May, the company launched the first product from its
Drugs
A 12/3-12/18/18 FDA inspection at Results RNA, Orem, UT, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/29 Warning Letter says specific violations were: * the firm’s quality control unit failed to exercise its responsibility to ensure drug products
Drugs
FDA says it is pleased that a DC federal court upheld the agency’s interpretation regarding the bulk substances that may be used by outsourcing facilities in drug compounding. An agency statement says FDA previously announced that vasopressin is not a bulk drug substance for which there is a clinical
Drugs
Hoffman-LaRoche and Genentech say they appreciate that an FDA draft guidance on enhancing the diversity of clinical trial populations takes a multifaceted approach. “However,” the companies’ comment letter says, “we believe that some of the recommendations provided in the draft guidance could be further expanded or clarified with regard
Drugs
An amended complaint by Pharmaceutical Research and Manufacturers of America (PhRMA) against a California drug pricing disclosure law has been given more stable footing after a federal court allowed the lawsuit to move forward. The controversial California law (see earlier story) requires pharmaceutical manufacturers to provide advance notice when raising
Drugs
AbbVie has submitted an NDA for elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist with a proposed indication for managing heavy menstrual bleeding (HMB) associated with uterine fibroids. The submission is based on data from the elagolix Phase 3 uterine fibroid program, which evaluated nearly 800 premenopausal women with uterine
Drugs
Foamix Pharmaceuticals has submitted an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in patients aged 18 years and older. The NDA submission is supported by data from two Phase 3 clinical trials, FX2016-11 and FX2016-12. “In these trials, FMX103 achieved both co-
Drugs
FDA has approved Bracco Diagnostics’ Aribar Thin Liquid (barium sulfate) for oral suspension, indicated for modified barium swallow (MBS) studies used to detect and assess the type and severity of swallowing disorders (dysphagia). During an MBS, a patient swallows products with different thicknesses containing a barium x-ray contrast agent,
Drugs
Draft Guide on Clin-Pharm Considerations for Neonatals Federal Register notice: FDA makes available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” 08/02/2019 Nonclinical Toxicology Studies Q & A Draft Guide Federal Register notice: FDA makes available a draft guidance
Drugs
FDA has allowed Momenta Pharmaceuticals to proceed under its IND to begin an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm autoimmune hemolytic anemia (wAIHA). If successful, the adaptive Phase 2/3 study could serve as a pivotal study which could enable nipocalimab to
Drugs
FDA has approved a Daiichi Sankyo NDA for Turalio (pexidartinib) capsules for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. TGCT is a rare tumor that affects the synovium (thin layer of tissue that
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (determined by an FDA-approved test) with disease progression after one or more prior lines of systemic therapy. Approval was based on data
Drugs
FDA has published a final guidance, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations, to give sponsors information on the design of an appropriate nonclinical program for developing radiopharmaceuticals to treat cancer, also known as oncology therapeutic radiopharmaceuticals. The document also contains recommendations for certain aspects of product labeling. The
Drugs
FDA has issued a draft guidance, Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers, with information for sponsors and nonclinical laboratory staff about the management and conduct of pathology peer review performed during good laboratory practice-compliant toxicology studies. “When conducted, pathology peer review should be well-documented,
Drugs
FDA has issued a final guidance, Bacterial Vaginosis: Developing Drugs for Treatment, to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for treatment of bacterial vaginosis. The document focuses on considerations that are specific to bacterial
Drugs
FDA has expanded the approval for Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The agency also granted Enstilar Foam pediatric exclusivity, extending it by an additional six months to 12/
Drugs
Ultragenyx Pharmaceutical has submitted to FDA an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders (LC-FAOD), a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. The submission is based on data from a Phase 2
Drugs
FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of
Drugs
FDA and HHS have published a Safe Importation Action Plan outlining two potential pathways to lay the foundation for the safe importation of certain drugs originally intended for foreign markets. An HHS statement says the plan outlines the pathways the Trump administration “intends to explore to allow safe importation of
Drugs
FDA has released the FDA-483 issued following a 7/15-7/19 inspection at the Cipla Virgonagar, India, active pharmaceutical ingredient (API) manufacturing site. The inspection observations were: * inadequate investigations into out-of-specification QC analytical results, related to finished API product quality failures; * failing to adequately design, install,
Drugs
FDA has approved a Bayer NDA for Nubeqa (darolutamide), an androgen receptor inhibitor for treating patients with non-metastatic castration-resistant prostate cancer. Approval is based on data from the Phase 3 ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a significant improvement in the primary efficacy
Drugs
FDA has released the FDA-483 issued following a 7/8-7/12 inspection at the Dr. Reddy’s Laboratories Unit 2 active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. The inspection observations were: * investigations into product complaints and out-of-specification quality control analytical results, related to