Devices
FDA has cleared a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. The company describes the device as a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It allows for up
Drugs
FDA has issued Sun Pharmaceutical (Gujarat, India) a three-page Form 483 after a February inspection cited GMP deviations for finished pharmaceuticals. For example, the inspection form says Sun failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
FDA Policy/General
Federal Register notice: FDA has announced a 4/25 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance “Rare Diseases: Natural History Studies for Drug Development.” The document says that a natural history study collects information about a disease’s natural history in the absence of an intervention, from the disease’s onset until either its resolution or
Devices
FDA has cleared a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions. The company describes the device as the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. It is designed to eliminate the need for a second invasive procedure.
Drugs
Bayer and Janssen Pharmaceuticals have agreed to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged serious and sometimes fatal bleeding episodes. Bayer expects its liability insurance to cover part of the settlement costs. While the companies say the claims are without merit
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Rosa One Spine System for robotically assisted spine surgeries. The device combines robotics and navigation “while delivering a unique real-time patient dynamic tracking capability,” the company says. “The platform features 3D intraoperative planning software in addition to a navigation
FDA Policy/General
Workshop on Nontuberculous Mycobacterial Disease Drugs Federal Register notice: FDA announces a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” 03/22/2019 Antimicrobial Drugs Advisory Committee Meeting on Bacitracin Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee
Drugs
FDA has issued a safety alert about cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. “Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities,” the alert
Drugs
FDA has made available a draft guide entitled “Rare Diseases: Natural History Studies for Drug Development.” The document is intended to help inform the design and implementation of natural history studies that can be used to support safe and effective drug and biological product development for rare diseases. Specifically, it
Devices
FDA has cleared a Genetesis 510(k) for its cardiac imaging platform, which pairs its CardioFlux Magnetocardiograph with the integrated Faraday Analytical Cloud (FAC). The company says the new technology provides emergency room physicians and cardiologists with access to measure and visualize magnetic fields produced by the heart’s natural
Drugs
CDER’s Office of Clinical Pharmacology (OCP) says that in 2019 it will focus on current health issues related to the opioid epidemic, antimicrobial resistance, and rare diseases. In its latest annual report, OCP says the application of pharmacogenomic information will continue to play an important role in clinical trial
FDA Policy/General
Federal Register notice: FDA has announced a 4/26 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and effectiveness of bacitracin for intramuscular injection for treating infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only
Drugs
FDA has issued a safety alert on the investigational use of AbbVie/Genentech’s Venclexta (venetoclax) for treating patients with multiple myeloma based on data showing an increased death risk for patients on the therapy compared to those on an active control. Earlier this month, the agency placed a partial
Drugs
FDA has issued Lexicon Pharmaceuticals and Sanofi a complete response letter on their NDA for investigational Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the companies say they will work closely with the agency to
Drugs
FDA has issued Recro Pharma a complete response letter for intravenous (IV) meloxicam for managing moderate to severe pain. The letter focused on onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs, according to the company. It also cited
FDA Policy/General
Federal Register notice: FDA has announced a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” FDA officials and attendees are expected to discuss clinical trial design considerations, including endpoints, related to developing antibacterial drug products for treating the disease. To view the
Drugs
Indiana University School of Medicine researcher Xiongbin Lu is reporting several important findings related to triple negative breast cancer and its treatment. Unlike the three most common forms of breast cancer, he says, triple negative breast cancer has no approved targeted therapies for treatment. In a paper, Lu and University
Drugs
Biogen and Eisai have discontinued global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. Their decision is based on a futility analysis conducted by an independent
Devices
FDA has cleared a GenePOC 510(k) for the GenePOC Strep A assay for use on its revogene device. The qualitative in vitro diagnostic test is intended for detecting Streptococcus pyogenes nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The assay can provide
Drugs
As part of the FDA program to use real-world evidence based on real-world data for safety and efficacy decisions involving drugs, demonstration projects will cover data, real-world evidence tools, and real-world evidence study design. CDER Office of Medical Policy director Jacqueline Corrigan-Curray reviewed in a
Devices
FDA has approved an Impulse Dynamics PMA for the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The device comprises