Drugs
FDA has issued a warning about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. “Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of
Drugs
FDA has placed a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin and its use in improving glycemic control in Type 1 diabetes patients. Cadisegliatin is an oral, liver-selective, glucokinase activator that the company says has been well-tolerated in over 500 subjects to date
Drugs
A January inspection of Brassica Pharma’s sterile drug manufacturing facility in Maharashtra, India resulted in a just-posted 10-observation Form FDA-483 that cited significant GMP violations. For example, agency investigators said the firm’s lab records did not include complete data derived from all tests and examinations
Drugs
FDA has granted fast-track designation for AC Immune’s ACI-35.030 (now in development with Janssen as JNJ-2056) for Alzheimer’s disease. A company statement says the drug targets the pathologic form of the Tau protein, phosphorylated Tau. The Phase 2b ReTain clinical trial is recruiting participants
Drugs
FDA says Aurobindo Pharma recalled 7/18 one lot of its Healthy Living OTC Migraine Relief (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) due to a missing manufacturer label. The agency announcement says the company began shipping the affected batch to customers nationwide in January. Some bottles
Drugs
FDA has approved a Mirum Pharmaceuticals label expansion for Livmarli (maralixibat) oral solution for treating cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as a higher drug concentration formulation evaluated in the company’s
Drugs
Abbott has initiated a medical device correction for some of its FreeStyle Libre 3 sensors distributed in the U.S. during the first half of May. “Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a
Drugs
FDA has opened a public docket to receive information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). A Federal Register notice says the agency is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs
Drugs
FDA has released the form FDA-483 issued following a 6/10-6/14 inspection at Biocon Biosphere, a drug manufacturing facility in Andhra Pradesh, India. The three inspection observations were: * failure to establish written procedures for production and process controls designed to assure that drug products have the identity,
Drugs
Pfizer says it will discuss with FDA plans to seek approval of its investigational gene therapy for treating adults with moderately severe to severe hemophilia A. The move follows just-announced “positive topline results” from the Phase 3 AFFINE study (NCT04370054), according to the company. “The AFFINE study achieved its
Drugs
FDA has published a guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products, as part of the agency’s real-world evidence program under the 21st Century Cures Act. The document is intended to provide sponsors and
Drugs
FDA has published a guidance, Container Closure System and Component Changes: Glass Vials and Stoppers, to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across several FDA guidances. The document has recommendations for holders of NDAs, BLAs, and ANDAs about the reporting and implementation of
Drugs
Attorney Julie Tibbets (Goodwin) has identified the two most common bioresearch monitoring (BIMO) violations shown in FY 2023 Warning Letters to clinical investigators. She says the most common violations were: * failure to ensure that the investigation was conducted according to the investigational plan; and * failure to submit an IND application
Drugs
FDA has denied a Novartis 9/12/2022 petition asking that the agency not approve certain ANDAs that cite Entresto (sacubitril and valsartan) tablets in various doses as the reference-listed drug. Specifically, the petition asked that FDA: * not approve any ANDA referencing Entresto until the 2/16/2024 expiration
Drugs
FDA has accepted for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer. The agency has set a user fee review action target date of 3/24/2025. “If approved, the new kit will enable
Drugs
FDA has released a final guidance entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” The document is intended to assist submitters by describing the electronic OTC monograph submissions requirements, and providing recommendations and other information on how to send such submissions to FDA. FDA regulations require that all
Drugs
A 12/15-12/23/2023 FDA inspection at the Yahon Enterprise Co., Ltd. drug manufacturing facility in Trang Bom District, Vietnam, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/5 Warning Letter says specific violations were: * failure to have, for
Drugs
Hikma Pharmaceuticals is extending a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence of a bag labeled dexmedetomidine HCl injection (400mcg/100mL) inside the overwrap that is labeled acetaminophen injection. If providers do not identify the drug inside the acetaminophen overwrap
Drugs
A 1/15-1/19 FDA inspection at the drug manufacturing facility operated by Brassica Pharma Pvt. Ltd. in Thane, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says specific violations were: * failure to ensure that laboratory records included
Drugs
Merck is reporting positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. Clesrovimab met its primary safety and efficacy endpoints in the trial, including reducing medically attended
Drugs
Experts from FDA, the American Association for Cancer Research (AACR), and the American Statistical Association (ASA) have published considerations for clinical trial designs to enhance the collection and analysis of overall survival data in the context of modern-day cancer treatments. The work was published in Clinical Cancer Research. An
Drugs
Johnson & Johnson has filed a supplemental NDA seeking approval of Spravato (esketamine) nasal spray as monotherapy for adults living with treatment-resistant depression (TRD). “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms, which