Devices
Baxter Healthcare is recalling (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a “low gas pressure alarm” if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not connected to the ventilator and turned on before
Devices
Pfizer has submitted several pages of specific line-by-line comments in response to an FDA draft guidance on “incorporating voluntary patient preference information over the total product lifecycle.” Among its recommendations are: * revise the guidance title to reflect that it focuses on patient preference information relating to medical devices;
Drugs
Researchers from Case Western Reserve University School of Medicine have found that semaglutide, a popular diabetes and weight-loss drug, may reduce the risk of Alzheimer's disease in people with Type 2 diabetes (T2D). The findings, published in the latest issue of Alzheimer’s & Dementia: The Journal
Drugs
The American Society of Health-System Pharmacists (ASHP) says that as of September, the number of active drug shortages as tracked by the University of Utah Drug Information Service was 277, down from an all-time high of 323. ASHP reports that 50% of active shortages have persisted for two
FDA Policy/General
An FDA safety alert is warning about Regener-Eyes manufactured by Regenerative Processing Plant because the drops likely contain amniotic fluid. The agency says it has received two adverse event reports about “shooting pain in the eyes: after using Regener-Eyes, an ophthalmic drug product marketed for dry eye conditions.
Drugs
FDA has accepted for priority review a Telix NDA for Pixclara (18F-floretyrosine), a positron emission tomography agent for glioma imaging. The agency has set a user fee review action target date of 4/26/2025. The therapy is intended for use to provide a characterization of progressive or recurrent
Drugs
Alto Neuroscience says a Phase 2b study of ALTO-100 in patients with major depressive disorder (MDD) did not meet its primary endpoint, assessed by a change from baseline in a depression rating scale compared to placebo. The company expects to complete its analysis of the full data set before
FDA Policy/General
Federal Register notice: FDA is announcing a 12/12 Vaccines and Related Biological Products Advisory Committee meeting. Committee members are scheduled to discuss considerations for respiratory syncytial virus (RSV) vaccine safety in pediatric populations. They will also hear overviews of CBER’s Laboratory of Immunoregulation and Laboratory of Retroviruses research
Biologics
An 8/15-8/29/2022 FDA inspection at Pinnacle Transplant Technologies in Phoenix, AZ, documented that the firm manufactures an amniotic membrane and an amniotic fluid-derived product. A 10/1 Warning Letter says the firm’s two PalinGen products are legally considered to be biologics and require a
Drugs
Novo Nordisk is petitioning FDA to add its semaglutide products (Ozempic and Wegovy) to the Demonstrable Difficulties for Compounding (DDC) lists. The firm’s nominating petition says the products belong on the lists “due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes,
Biologics
FDA has approved expanding the indication for Pfizer’s respiratory syncytial virus (RSV) Abrysvo vaccine to cover the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. Abrysvo had been approved for those aged 60 and older. A company statement says
Drugs
A California man operating a company called Warrior Labz SARMs has pleaded guilty to selling unapproved drugs. According to the Justice Department, Jeremy Brown sold selective androgen receptor modulators, unapproved versions of erectile-dysfunction drugs Viagra and Cialis; and unapproved versions of weight-loss drugs Ozempic, Wegovy, and Rybelsus from
Drugs
FDA has granted U.P. Oncolytics an orphan drug designation for its oncolytic virus-based therapy to treat malignant gliomas. Last month, the company was awarded a $500,000 from NIH as part of a Phase 1-2 fast-track grant that will fund the company’s proposed in vitro
FDA Policy/General
FDA is planning research to consider the influence of statements around patient adherence and preference in prescription drug promotion. A Federal Register notice says it isn’t known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer
FDA Policy/General
FDA commissioner Robert Califf says FDA is “entering an era where we’re going to have to rethink everything we do because of the technology changes that we’re seeing, which affect every single industry that we’re dealing with.” As reported by Chief Healthcare Executive, Califf spoke to the
Drugs
An FDA 6/12-6/23/2023 Bioresearch Monitoring inspection at a clinical trial site maintained by Dr. Namita Goyal, an Orange, CA, neurologist, found that she violated regulations governing the proper conduct of clinical studies involving investigational products. A 10/10 Warning Letter says specific violations were: * failure to
Biologics
An 8/15-/29/2022 FDA inspection at Amnio Technology in Phoenix, AZ, documented that the firm manufactures an amniotic membrane and fluid product and an amniotic fluid-derived product that have been distributed to third-party distributors, hospitals, and medical clinics in the U.S. A 10/1 Warning
Drugs
Otsuka Pharmaceutical is reporting “positive topline interim data” from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephropathy (IgA nephropathy) in adults. The investigational anti-APRIL (a proliferation-inducing ligand) monoclonal antibody works by blocking a “key initiating step in the immune pathogenic
Drugs
FDA has issued Camurus a complete response letter (CRL) on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acromegaly. The agency letter cited “facility-related deficiencies identified during a current good manufacturing practices inspection of a third-party manufacturer completed in September,” the
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 9/20 notice on a draft guidance entitled “Chemical Analysis for Biocompatibility Assessment of Medical Devices” that recommends methodological approaches for chemical analysis for devce biocompatibility assessments. Electronic or written comments on the draft guidance can now be submitted
Drugs
FDA has published a draft guidance, Drug Interaction Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in determining the appropriate placement and content of drug interaction information in labeling as described in the regulations for the content and format of labeling for human prescription drug and
Biologics
Sangamo Therapeutics says it reached agreement with FDA on a “clear regulatory pathway to accelerated approval for the company’s gene therapy candidate ST-920 (isaralgagene civaparvovec) for treating Fabry disease. The FDA has agreed in a Type B interaction that data from the ongoing Phase 1/2 STAAR study