Drugs
Indian drug companies are holding monthly meetings to share FDA-483s that have been received after inspections and their responses to the inspection observations to improve compliance. Bloomberg’s BQ Prime reports that the companies are acting as FDA ramps up inspections in India following a determination that Indian companies
Biologics
FDA has granted Sarepta Therapeutics accelerated approval for its BLA for Elevidys, the first gene therapy to treat pediatric patients aged four through five years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing
Drugs
A 10/2022 FDA inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL resulted in a just-posted seven-item Form FDA-483. During the inspection, agency investigators cited the firm’s quality control unit because it lacked the authority to review production records to assure that no errors
Devices
FDA has cleared an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies. The device, which features the company’s wire-free sock design, provides a real-time display of a baby’s pulse rate and oxygen saturation level (SpO2) and alerts parents when
Drugs
FDA has approved Sebela Pharmaceuticals’ Suflave (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) for colonoscopy preparation in adults. The company says Suflave is a low-volume, safe and effective colonoscopy preparation with a taste similar to a lemon-lime sports drink that was
Drugs
Novartis says it welcomes FDA efforts to draft a guidance for pharmacogenomics (PGx) work and submission in the context of drug development. The company’s comment letter says the guidance as drafted “would significantly influence the way we report exploratory pharmacogenomic research.” It asks for further FDA guidance on the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program.” The document discusses the agency’s intention to pilot a new approach to provide greater transparency on performance characteristics that certain tests for oncology biomarkers should meet.
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug product application. FDA based the order on Diaz’s felony conviction related to her role as a research assistant and assistant study
Drugs
The Physicians Committee for Responsible Medicine is petitioning FDA to require that all product packaging and labeling for glucagon-like peptide-1 (GLP-1) receptor agonists disclose that a plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, weight loss
Drugs
A 9/19-10/26/2022 FDA inspection at Chicago Cornea Consultants in Highland Park, IL, found “objectionable conditions” in the conduct of two clinical investigations. A 6/14 Warning Letter says the inspection was part of the agency’s Bioresearch Monitoring Program. The Warning Letter says specific violations were:
Biologics
FDA has accepted for priority review a bluebird bio BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle cell disease ages 12 years and older who have a history of vaso-occlusive events. The agency has set a user fee review action target date of 12/
Drugs
Pieris Pharmaceuticals says its partner AstraZeneca has decided to discontinue and stop dosing in the clinical study of elarekibep, an inhaled IL-4 receptor alpha inhibitor being developed to treat asthma. A Pieris statement says the decision was based on lung findings from a non-clinical 13-week GLP toxicology
Drugs
FDA has issued a complete response letter to Aldeyra Therapeutics for its 505(b)(2) NDA for ADX-2191 (methotrexate for injection), an investigational drug candidate to treat primary vitreoretinal lymphoma (PVRL). A company statement says that while no safety or manufacturing issues were identified, the agency stated that there
Devices
FDA has granted Anumana a breakthrough device designation for its ECG-AI algorithm, which is designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. “The use of AI algorithms to identify subtle signals in [electrocardiograms] ECGs that are imperceptible to humans
Devices
FDA commissioner Robert Califf says the agency has met with officials of the leading ChatGPT companies “and they want to be regulated. But even they don’t really have good suggestions now on how to do it.” Califf commented at a recent Biotechnology Innovation Organization convention, as reported by Bloomberg
Drugs
A report produced by the Brookings Institution’s Hamilton Project offers a policy intervention with three components to help address shortages of generic sterile injectable (GSI) drugs. The report says shortages of GSI drugs “compromise patient care in emergency rooms and intensive care units, in cancer treatment, and during elective
Biologics
FDA has granted full approval to Amgen’s previously accelerated-approved BLA for Blincyto (blinatumomab) for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Drugs
FDA has approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments, in addition to diet and exercise, for improving blood sugar control in children 10 years and older with Type 2 diabetes. Empagliflozin works by increasing glucose excretion in the urine, according to an FDA
Drugs
Twenty-five bipartisan House representatives are urging FDA to create patient-centered policies on compounded hormones that maintain patients’ access to care and treatment options. In a 6/20 letter to FDA commissioner Robert Califf, the lawmakers said they were concerned that recommendations in a 2020 National Academies of Sciences,
Drugs
FDA has launched a voluntary pilot program to help cut risks in using laboratory-developed tests (LDTs) to identify cancer biomarkers. An online statement says the agency has become increasingly concerned that some tests made by laboratories and not authorized by FDA may not provide accurate and reliable test results
Drugs
FDA has issued F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or no treatment options. The letter requested additional data and analyses before it can approve the submission, according to the company. “The FDA encouraged the
Devices
A 1/24-1/31 FDA inspection at Vitang Technology in Tustin, CA, determined that the firm is marketing the misbranded and adulterated UniSmile Clear Aligner, a Class 2 dental aligner that was cleared under a 510(k). A 6/12 Warning Letter says the medical device is misbranded because