Drugs
A federal jury has returned guilty verdicts against former Florida pain doctor Steven Chun and former Insys sales rep Daniel Tondre in a healthcare fraud kickback case, according to a Department of Justice statement. Both men were found guilty of conspiring to pay and receive kickbacks and bribes, in the
Devices
FDA has granted de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient blood for subsequent analysis. “This FDA regulatory clearance is the culmination of a sustained effort by the company for over six years including extensive dialog and
Drugs
Staff from FDA and the European Medicines Agency say good clinical practice (GCP) inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued collaboration between the two regulatory agencies. The two organizations have collaborated in GCP inspections since 9/2009. They
Drugs
Former FDA attorneys William Schultz and Margaret Dotzel (both Zuckerman Spaeder) say the BLOCKING (Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics) Act, if passed, “will not accelerate generic drug entry. Instead, it will upend the critical 180-day exclusivity incentive by making it far less
Drugs
Harvard Medical School researchers say proposed legislation to require dietary supplement manufacturers to provide FDA with some basic information should be revised significantly to make it a true reform and oversight bill. Writing in a New England Journal of Medicine opinion piece, the researchers say the Dietary Supplement Listing Act
Drugs
FDA has granted fast track designation to Elevation Oncology’s seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions. The company says it is evaluating seribantumab in the Phase 2 CRESTONE study.
Devices
FDA has cleared an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use during cardiac ablation, such as ventricular tachycardia (VT). The device is intended to address many of the challenges of conventional VT
Drugs
FDA has approved a Servier supplemental NDA for Tibsovo (ivosidenib tablets) in combination with azacitidine for treating newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or those who have comorbidities that preclude use of intensive induction chemotherapy. Approval was based on data from the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Importation of Prescription Drugs Final Rule Questions and Answers.” The guidance is intended to help small entities comply with the 2020 final rule entitled “Importation of Prescription Drugs” that implemented a provision of the Federal Food, Drug, and Cosmetic
Drugs
FDA has accepted for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief of heartburn, as well as the maintenance of healing and relief of these conditions. Vonoprazan is described as a novel, orally administered investigational potassium-competitive
Drugs
FDA has published a guidance, Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity Compliance Guide), to help small entities better understand the 10/1/20 final rule on the importation of prescription drugs. The agency says the Q&A document restates in plain language the legal
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a proposed rule on national standards for licensure for wholesale drug distributors and third-party logistics providers that published 2/4. Electronic comments must be submitted by 9/6. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at the Broad Institute of MIT and Harvard for the CRSP SARS–CoV–2 Real-time Reverse Transcriptase — PCR Diagnostic Assay because Covid testing under the EUA is no longer occurring. To
Drugs
FDA has issued Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia (BPH). The letter referenced a “new outstanding issue of longer-term safety data” and it indicated the submission needed to have longer-term safety data, Nymox says. “Longer-term
Biologics
FDA has accepted for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adults with hemophilia B. The therapy is designed to “make near-normal blood-clotting ability possible by addressing the underlying cause of hemophilia B: a faulty gene that causes a deficiency
Biologics
The Informed Consent Action Network (ICAN) is petitioning FDA to revoke the 5/10/21 reissuance of an emergency use authorization (EUA) for Pfizer/BioNTech’s Covid-19 vaccine in children ages 12 through 15. ICAN also asks FDA not to authorize Moderna’s request for EUA of its Covid-
Drugs
FDA says its review of a Web site and social media pages maintained by Santhigram Kerala Ayurvedic of U.S., Inc., North Brunswick, NJ, found that it is selling products whose uses establish that they are unapproved new drugs. A 5/19 Notice of Violation also says the company describes
Drugs
More than 35 health experts and advocacy groups including U.S. PIRG (Public Interest Research Group) are calling on the Senate HELP Committee to include stronger enforcement of post-market clinical trials for accelerated approval drugs in its coming markup of draft FDA user fee legislation. U.S. PIRG says
Drugs
FDA has published a draft guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers (Revision 1), to assist sponsors in developing new antibacterial drugs. Specifically, the document explains the agency’s current thinking about possible development programs and clinical
Drugs
Vanda Pharmaceuticals is asking the DC federal court to set aside FDA’s denial of fast track status for the company’s tradipitant to treat gastroparesis and order the agency to reconsider Vanda’s application based on the statutory framework. The suit says the fast track designation is intended to
Devices
FDA has cleared a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism. The artificial intelligence-based clinical decision support tool is designed to automatically identifies and sends notifications of suspected central pulmonary embolisms on computed tomography pulmonary angiogram images, the
Drugs
FDA has placed a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF without affecting trans-membrane TNF or TNF receptors. The company says the hold is related to an agency