Devices
FDA has cleared a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care unit and operating room. The device is intended for use in bronchoscopy procedures such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. The document provides the agency’s expectations for collection, analysis, and reporting of data pertaining to metastasis-free survival. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Development and Submission of Near Infrared Analytical Procedures.” The document provides recommendations to applicants to aid the development, validation, and use of near infrared-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances
Drugs
Axsome Therapeutics is warning investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). “As part of the ongoing review of our NDA for AXS-05, the FDA recently notified us that they have identified deficiencies that preclude labeling discussions
FDA Policy/General
The White House is denying that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in the running for the agency top job. First reported by Politico, hours later it was denied by White House spokesman Kevin Munoz. “Dr. Emanuel is not in the
Drugs
FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will host a two-day (9/1-2) virtual public workshop entitled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design.” The workshop is intended to discuss opportunities for leveraging complex and innovative trial designs,
Drugs
Acer Therapeutics and Relief Therapeutics have submitted an NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders (UCDs). The companies describe ACER-001 as a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase,
Drugs
FDA’s recent “intended use” rule and accompanying FDA preamble and response to comments offer important advertising and promotion guidance for pharmaceutical and medical device industries, such as the agency clarifying that it will not determine a firm’s intent regarding off-label use based solely on its knowledge that
Devices
FDA has cleared a SpinTech 510(k) for its Stage magnetic resonance imaging software. The software provides a rapid, multi-contrast imaging method that allows scanning the brain in about five minutes, “unlocking the full potential of MRI,” the company says. It provides 16 different types of image contrasts, six
Drugs
FDA has issued a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. The document provides recommendations on using such endpoints in clinical trials for nonmetastatic castration-resistant prostate cancer product development programs. For example, it recommends that: * Sponsors should establish the
Devices
FDA has granted Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around 30 swab samples per hour. Clinical studies show the test has sensitivity of at least 80% and specificity of 98.0%, according to
Biologics
FDA has approved a Genzyme BLA for Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients one year of age and older with late-onset Pompe disease. The intravenous enzyme replacement therapy helps reduce glycogen accumulation, according to an FDA news release. In Pompe patients, glycogen accumulation in skeletal
Devices
FDA has classified as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to the risk of incorrect transition to safety mode. Safety mode is intended to provide backup if the device is faulty, a recall notice says. “However, in safety mode, there is a
Drugs
FDA has issued a final guidance entitled Development and Submission of Near Infrared Analytical Procedures. The document provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products.
FDA Policy/General
Federal Register notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA. The 4/16 decision affirmed a district court ruling that FDA is not afforded discretion when a combination product
FDA Policy/General
Federal Register notice: FDA is extending the period for states to decide whether to sign the final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S.
Drugs
FDA has issued Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing and stating that a reinspection will be necessary to complete its review. The company is seeking an indication for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs. Spectrum says
Devices
Boston Scientific has received IDE approval to begin enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System (EKOS) in combination with anticoagulation therapy to anticoagulation alone for treating acute, intermediate-high-risk pulmonary embolism (PE). The collaborative research study is being conducted by the Pulmonary Embolism
Drugs
Researchers from several academic medical centers and other sites say there is no evidence to support an FDA class warning for suicidality in newer anti-seizure drugs. “Without the evidence to support it,” says Thomas Jefferson University professor Michael Sperling, one of the study authors, “the net effect of such
Drugs
FDA has granted Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma. Sotigalimab is described by the company as a CD40 agonist monoclonal antibody “with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability. In an ongoing Phase 2 clinical trial, sotigalimab
Drugs
Three FDA officials say the recent approval of Astellas’ Prograf (tacrolimus) in combination with other immunosuppressants for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when
Drugs
FDA has sent a complete response letter to Ardelyx for its NDA for tenapanor for the control of serum phosphorous in adult patients with chronic kidney disease on dialysis. The company says FDA found that the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorous in