Drugs
Novo Nordisk says a recent Phase 2 trial of monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist, in diabetic kidney disease patients failed to meet its primary endpoint. The trial evaluated the therapy’s efficacy and safety of once-daily 10 mg and 25 mg dosing compared
Drugs
A 7/29-8/2/2024 FDA inspection at the Global Calcium drug manufacturing facility in Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/16 Warning Letter says the specific deviations were: * failure of the firm’s quality
Biologics
FDA has approved a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. Susvimo is the first FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-
Drugs
A 9/18-9/20/2024 FDA inspection of the contract testing laboratory at the Center for Instrumental Analysis of China Pharmaceutical University in Jiangsu Sheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/23 Warning Letter says specific deviations
Devices
FDA says the Trokamed 11/26/2024 recall that updated instructions for its Mini PCNL sheath is Class 1. An agency notice says Trokamed recommended these actions: * not to use the Mini PCNL sheath as a suction and irrigation device; * temporarily remove the nephroscope from the shaft to clear it
Drugs
FDA has approved a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection as the first subcutaneous apomorphine infusion device for treating motor fluctuations in adults with advanced Parkinson’s disease. The approval follows two previous complete response letters seeking additional information from the company. In 4/2024, FDA issued its
Devices
The Justice Department says C.R. Bard and three affiliates have agreed to pay $17 million to resolve a whistleblower’s allegations that they violated the False Claims Act and several state false claims acts by providing free samples and discounts to encourage urology practice groups to use Bard’s
FDA Policy/General
Doctors for America, a health justice organization representing 27,000 doctors and medical students nationwide, is suing FDA, CDC, HHS, and the federal Office of Personnel Management over the removal of a broad range of health-related data and other information used by health professionals and researchers from publicly accessible
Devices
FDA has granted Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system, which uses the “K-Edge subtraction technique” to enable contrast-enhanced imaging for diagnosing breast cancer. “This technology utilizes Lumitron’s proprietary distributed charge laser-Compton technology to provide imaging that is both 100 times
Drugs
Despite his many years of advancing vaccine skepticism, Robert F. Kennedy Jr.’s nomination to be the next HHS secretary moves one step closer to completion after the Senate Finance Committee voted 2/4 to advance it to a floor vote. The 14-13 vote followed party lines. The committee’
Devices
Medtronic Neurosurgery is recalling (Class 1 device correction) certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcocks. “The use of affected product may cause serious adverse health consequences, including leaks of cerebrospinal fluid, infections, and death,” a recall notice
FDA Policy/General
Federal Register notice: FDA is revising the effective dates on two recent final guidances entitled “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” and “Recommendations To Reduce the Risk of Transmission of Mycobacterium
Drugs
Olympus is recalling (Class 1) its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing. Due to the risks, the company says alternatives to the MAJ-891 should be used. A recall notice says patient infections could result from exposure to a contaminated device
Drugs
A final guidance released earlier this month on communicating scientific information to healthcare professionals (HCPs) about unapproved uses of medical products emphasizes the importance of selecting appropriate source publications to share, and companies should select those that “describe scientifically sound studies and analyze and use generally accepted design and methodological
Drugs
Pfizer says it will seek full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer harboring a BRAF V600E mutation. The decision to seek full approval is based on positive data from the confirmatory Phase
Devices
FDA has cleared an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses. EssilorLuxottica says the device provides an open-ear hearing solution integrated into a pair of smart glasses. “After decades of adoption barriers ranging from comfort to visibility, consumers will finally be able to see clearly
Devices
FDA has cleared a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during anterior hip arthroplasty. The company says the device is designed to improve acetabular cup placement accuracy to reduce post-surgery complications. Unlike traditional hip navigation approaches, the Gyder
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a groundbreaking move away from opioid pain drugs for treating moderate to severe acute pain in adults. The first-in-class drug offers a novel approach to pain relief by targeting sodium channels in the peripheral nervous system, preventing pain
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Labeling Requirements for Prescription Drugs.” The collection supports the statutory and regulatory requirements that govern the labeling of prescription drugs. The collection is being revised to include burden associated new medical gas labeling requirements established by a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Biosimilars User Fee Program.” The document supports the agency’s biosimilar review and user fee program that allows an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference
Drugs
An FDA alert is advising healthcare providers about Fresenius Kabi’s Ivenix large-volume pumps and their increased chance of issuing a non-recoverable pump problem alarm. The company has identified a subset of pneumatic valves installed in some Ivenix pumps that could experience the alarm issue. The alert says
Drugs
Mercury Medical is recalling (Class 1) its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. A malfunctioning device could reduce positive pressure, affecting a patient’s breathing support, a recall