Drugs
A 7/5-7/8/22 FDA inspection at Premier Nutra Pharma, in Carlsbad, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/9/22 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
The DC federal court says FDA correctly determined that Ipsen Biopharmaceuticals’ Somatuline Depot should be regulated as a drug rather than as a biologic. Ipsen had argued that the FDA decision was arbitrary, capricious, an abuse of discretion, and contrary to law. Ruling on cross motions for summary judgment filed
Drugs
FDA has accepted for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion. The submission is based on data from two Phase 3 studies (BALATON and COMINO) showing that the therapy provided early and sustained improvement in vision, which met the primary
Drugs
FDA has granted Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian cancer and endometrial cancer. The targeted DNA damage response inhibitor therapy is being studied in a multicenter, open-label, single arm Phase 2 clinical trial in patients with platinum-resistant ovarian cancer,
Drugs
FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. A company statement says the approval was based on positive results from the Phase 3 DELIVER trial. Farxiga
Drugs
FDA has removed a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in patients with Ewing sarcoma, a rare and deadly pediatric bone cancer. Salarius says the hold was lifted following the submission of “safety and clinical information to assure the FDA of
Drugs
Members of the FDA Pulmonary-Allergy Drug Advisory Committee will discuss 5/11 whether the ARS Pharmaceutical development program for its ARS-1 (intranasal epinephrine) is sufficient to support a favorable benefit/risk assessment for an indication for emergency treatment of allergic reactions (Type 1) including anaphylaxis in some adults
Drugs
FDA has lifted a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea. The product is designed to target a digestive tract disorder that is commonly caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC), according to
Drugs
FDA has approved Eyenovia’s Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedures and in situations when short term pupil dilation is needed. The company says the device was designed to improve the efficiency in office-based eye exams, as well as pharmacologic mydriasis applications
Drugs
FDA is holding a 5/11-12 workshop entitled “Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop.” The workshop is intended to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these. Topics that will
Drugs
FDA 5/8 granted Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for
Drugs
FDA has posted a “consent decree non-compliance” letter to Sun Pharma outlining inspectional findings at the company’s Mohali (Punjab), India manufacturing facility that led to the agency ordering it to take additional corrective actions to get back into compliance with a 2012 consent decree (see earlier story). Sun
Drugs
FibroGen says a Phase 3 study of its anemia drug roxadustat did not meet its primary efficacy endpoint. The MATTERHORN study involving roxadustat for treating anemia in 140 patients with transfusion-dependent lower risk myelodysplastic syndromes showed the proportion of patients who achieved red blood cell transfusion independence in the
Drugs
FDA has issued San Diego-based Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January and citing GMP deficiencies. For example, the inspection form says the firm’s quality oversight of validation activities is inadequate. It also cited its facility and equipment maintenance
Drugs
A citizen petition from Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines, and Council for Affordable Health Coverage asks FDA to not approve a proposal from Colorado’s Department of Health Care Policy & Financing that seeks to import drugs from Canada. The petition says the proposal was
Drugs
FDA reviewers are questioning the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a norgestrel tablet 0.075 mg oral contraceptive pill. In a briefing document released in advance of a
Drugs
FDA has accepted for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension. The agency has set a 12/22 user fee review action target date of 12/22. The submission is based on data from two Phase 3 pivotal trials
Drugs
Public Citizen says it is strongly urging FDA to reject the sNDA submitted by Otsuka Pharmaceutical Co. and Lundbeck for an expanded indication for Otsuka’s atypical antipsychotic Rexulti (brexpiprazole) to treat agitation associated with Alzheimer’s dementia (AAD). The advocacy group’s 5/3 letter says the drug’s
Drugs
The Government Accountability Office (GAO) says the National Institutes of Health (NIH) can do a better job of ensuring that recipients of funds for research and development of FDA-approved drugs acknowledge the government’s role in their work. Members of Congress asked GAO to review how NIH-funded biomedical
Drugs
Xortx Therapeutics says a meeting with FDA staff put it in a better position to move toward accelerated approval for its Xorlo to treat autosomal dominant polycystic kidney disease (ADPKD). A company statement says the meeting was held to discuss details of the accelerated approval process and a clinical trial
Drugs
FDA and the Duke-Margolis Center for Health Policy have jointly announced a 6/7-8 public workshop on the agency’s Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development. The workshop will discuss: * The pilot program, including application process and required
Drugs
FDA has issued a complete response letter to Novo Nordisk for its concizumab anti-tissue factor pathway inhibitor antibody, asking for additional information related to the monitoring and dosing of patients to ensure that the product is administered as intended. FDA also wants more information on the manufacturing process. Company