FDA Policy/General
Federal Register notice: FDA is announcing a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for Lumakras (sotorasib) tablets that seeks to convert the previous accelerated approval to full approval for treating adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell
Devices
Unlike the regulatory requirement for nonprescription drugs that users must be able to self-diagnose, for over-the-counter medical devices FDA should recognize that the safe and effective use may not require that patients can self-diagnose the underlying medical condition. This is one of several recommendations in the
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Huntington’s disease (HD). Previously, the drug was approved for treating adults with tardive dyskinesia. Approval was based on data from two clinical studies conducted in collaboration with the Huntington Study Group
Drugs
FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating magrolimab to treat acute myeloid leukemia (AML). The hold, which applies to new patients entering magrolimab studies, follows the company’s recent announcement that it is discontinuing the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic
Drugs
FDA has accepted for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). Geron says imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies
FDA Policy/General
Federal Register notice: FDA has identified two drug substances that will not be added to its list of bulk drug substances (active pharmaceutical ingredients) that are acceptable for drug compounding —ephedrine sulfate and hydroxychloroquine sulfate. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting an 8/14 notice that announced a modification to the organizational structure of CDRH’s Office of Strategic Partnerships and Technology Innovation. The original notice omitted that the agency is not implementing the new organizational structure until after the necessary requirements are completed. To
Drugs
The U.S. Justice Department 8/21 announced deferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA and Glenmark Pharmaceuticals. The agreements are part of a years-long probe into price fixing by several generic drug companies, according to the government. As part of the agreements, Teva admitted
FDA Policy/General
CDER Office of Prescription Drug Promotion (OPDP) has cited Florham Park, NJ-based Exeltis USA for making in a social media post false or misleading claims and representations about the risks and efficacy of its contraceptive Slynd (drospirenone) tablets. OPDP also cited the firm for not submitting its promotional materials
Drugs
FDA is planning to finalize by 9/30 its draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which replaced a 2018 draft guidance on content of premarket submissions for management of cybersecurity in medical devices. If all goes as planned, the guidance will
Drugs
After resolving inspection concerns at its contract manufacturer (Catalent) that were raised in a 6/27 complete response letter (CRL), Regeneron Pharmaceuticals was granted FDA approval 8/18 for Eylea HD (aflibercept) injection 8 mg, a higher dose of the popular 2 mg treatment for patients with wet age-related
Drugs
While the U.S. continues to struggle with ongoing drug shortages, particularly cancer drugs, FDA commissioner Robert Califf will be heading soon to India to meet with Indian regulatory and drug industry officials, according to HHS secretary Xavier Becerra. Speaking to reporters 7/18 on the sidelines of the G20
FDA Policy/General
Federal Register notice: FDA has determined that Accord Healthcare’s bortezomib solution was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the drug if all other legal and regulatory requirements are met. Bortezomib is indicated for treating adult patients with
FDA Policy/General
Federal Register notice: FDA is denying a request for a hearing and permanently debarring David Roy Winne from providing services related to an approved or pending drug product application. The debarment is based on Winne’s felony convictions related to his role as a technical director with AMA Laboratories, a
Devices
FDA has cleared an Anika Therapeutics 510(k) for the Integrity Implant System, intended for use in augmenting an injured tendon to promote healing in rotator cuff repair procedures. “Clearance of the hyaluronic acid (HA) based patch component joins the prior 510(k)s received for the associated fixation devices
Drugs
FDA has approved a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age and older with Chaple disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is described as a monoclonal antibody designed to target complement factor C5, a protein involved
Drugs
Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating adults with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor therapies. The oral hypoxia-inducible
Devices
FDA has updated its list of ultraviolet (UV) wand products that may present a potential risk of injury. Last year, the agency issued a safety warning about the use of certain brands of UV wands because the devices may expose users and any nearby people to unsafe levels of ultraviolet-
Devices
FDA has cleared a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device, which GE says allows real-time continuous monitoring with a personalized view of the patient’s vitals while keeping patients mobile during critical recovery periods. “Continuously monitoring patients and having a real time
Drugs
Medical device recall events fell 4.4% in the second quarter of 2023 from 252 in the first quarter to 241, according to the latest Sedgwick Recall Index. Meanwhile, the index says, drug recall events fell 6.3% from 144 in the first quarter to 135 in the second quarter.
Drugs
FDA has granted Nuvectis Pharma’s NXP800 an orphan drug designation for treating cholangiocarcinoma. The company describes NXP800 as an oral small molecule with a novel mechanism of action that has “demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as
Devices
FDA has cleared a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope. The company says the video processor is controlled using a “customizable, state-of-the-art touch panel, equipped with innovative image enhancement functionalities and 4K image processing.” The device also features