Drugs
FDA is notifying NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synapse Labs Pvt. Ltd. in Pune, India, are not acceptable due to data integrity concerns. An agency online notice says that studies conducted by Synapse must be repeated. “During analyses of study data generated at Synapse
Drugs
Several stakeholders are expressing their appreciation for FDA’s issuance of a draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products. Flatiron Health says the draft will give sponsors and real-world data (RWD) organizations clarity in regulatory expectations in designing a non-interventional
Drugs
FDA has published a report on the topics discussed at an 11/29-30/2023 public workshop it held with the Clinical Trials Transformation Initiative to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” The document provides information to applicants on how FDA will use information related to a facility’s readiness for inspection to set a goal date for an original ANDA. It incorporates a
FDA Policy/General
Federal Register notice: FDA is announcing a 7/17 educational conference (public meeting) entitled “First Annual Animal Drug User Fee Educational Conference.” This is the first of five annual educational conferences FDA will host as described in the ‘‘Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years
Devices
Stimwave founder and former CEO Laura Perryman has been sentenced to six years in prison by a New York federal judge in connection with a healthcare fraud scheme in which she created and sold a fake medical device component and told doctors they could claim $16,000 to $18,000
Devices
FDA is asking for input on certain non-device software functions and their impacts on patient safety. A Digital Health Reports online notice says the agency is requesting input on patient safety, including best practices to promote patient safety, education, and competence, associated with medical software functions that are excluded
Drugs
Researchers at Rutgers University and the University of California San Diego say that open access to three-dimensional atomic-level biostructure information from the Protein Data Bank (PDB) facilitated the discovery/development of 100% of the 34 new low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019
Drugs
AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced or metastatic triple-negative breast cancer did not meet dual primary endpoints of improvement in overall survival versus paclitaxel in combination with placebo in either the overall trial population or
FDA Policy/General
FDA Webview’s newsroom will be closed Wednesday 6/19 in recognition of the federal holiday Juneteenth. We resume our normal news operations on 6/20.
FDA Policy/General
Federal Register notice: FDA is issuing a final rule revising its requirements for current good manufacturing practice, postmarketing safety reporting, and labeling that apply to certain medical gases. The final rule also establishes regulations on certification of designated medical gases. To view the notice, click here.
Drugs
FDA has placed a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib studies, including a Phase 1 (ZN-c3-001) dose-escalation study in solid tumors, a Phase 2 (DENALI) study in platinum-resistant ovarian cancer, and a Phase 2 (TETON) study in uterine serous carcinoma. The action is in response
Devices
FDA has granted Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bioadaptor System for improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The device
Biologics
FDA has granted Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for: * Preventing invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of
Devices
FDA has cleared an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through a video game experience, EndeavorOTC is intended to improve attention function as measured by computer-based testing in men and women with primarily
FDA Policy/General
Federal Register notice: FDA is correcting a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).” The document erroneously included incorrect contact information and this notice corrects
Devices
Developing a medical device “quality assurance practice” for artificial intelligence (AI) models should be a priority to ensure clinical outcomes are optimal with the use of AI models that are “accurate, reliable, ethical, and equitable,” a new online agency post says. “Top of mind for device safety is quality assurance
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics,” which provides recommendations for developing oligonucleotide therapeutics. It addresses FDA’s current thinking about clinical pharmacology considerations and recommendations for oligonucleotide therapeutic development programs, including characterizing the potential for QT
Drugs
Takeda says topline data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) failed to meet their primary endpoints. The Phase 3 SKYLINE (TAK-935-3001) study evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome. “Soticlestat narrowly missed the
Drugs
FDA has placed a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating an early-stage antibody-drug conjugate (ADC) product candidate (BNT326/YL202) as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for use with carboplatin and paclitaxel, followed by single-agent pembrolizumab in adult patients with primary advanced or recurrent endometrial carcinoma. Approval was based on data from the KEYNOTE-868/NRG-GY018 (NCT03914612) trial that enrolled 810 patients with advanced or recurrent endometrial
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document addresses FDA’s current thinking about the overall development program and clinical trial designs for developing drugs to support an indication for treating diabetic foot infections. To view the notice,