Devices
Olympus has recalled (Class 1) its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the guide sheath component to separate and fall off into the patient. According to a recall notice, the cause of the component separation is under investigation by the company. Olympus
Drugs
AnaptysBio is reporting positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis (RA). The 424-patient Phase 2b RENOIR trial achieved its primary endpoint of the mean change from baseline in its disease activity score at Week 12 for all three doses of
Devices
Max Mobility has recalled its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board in its speed control remote that could lead to loss of control of the device. If a loss of control occurs, this could result in minor and major
Drugs
A 7/8-8/1/2024 FDA inspection at the Strukmyer Medical drug manufacturing facility in Mesquite, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 Warning Letter says specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
Drugs
An FDA review of records supplied by Chengdu Innovation Pharmaceutical Co. in Sichuan Sheng, China, following an agency 4/29/2024 request, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/5 Warning Letter says specific deviations were: * failure to test the identity
FDA Policy/General
DC federal judge John Bates has issued a temporary restraining order (TRO) requiring FDA and the Centers for Disease Control and Prevention (CDC) to restore Web pages they removed to comply with President Donald Trump’s executive order on gender ideology that mandated the recognition of only male and female
Drugs
National Center for Health Research president Diana Zuckerman and George Washington University and University of Maryland professor John Powers III say FDA should be focusing on how new antibiotics work in patients rather than looking at how they kill bacteria in a test tube. Writing in a STAT First Opinion
Drugs
FDA has accepted for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia (SCA), a rare genetic neurodegenerative disease. The company says the agency will take a review action on the NDA within six months or sometime during the third quarter. The submission is based
Devices
FDA has granted Guerbet a Breakthrough Device Designation for LipioJoint, a transient liquid embolic agent designed to alleviate pain in patients with knee osteoarthritis. The company says the device is being developed for Genicular Artery Embolization (GAE), a minimally invasive procedure performed by interventional radiologists. The product is intended to
Drugs
FDA has approved a SpringWorks Therapeutics NDA for Gomekli (mirdametinib), a kinase inhibitor for treating adult and pediatric patients two years of age and older with neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. Approval was based on data from the ReNeu (NCT03962543)
Drugs
FDA has accepted for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple myeloma (R/R MM) that has progressed after at least three prior therapies. The user fee review action target date was set for 7/10. Last August, the agency issued
Devices
Former FDA commissioner Scott Gottlieb, now an American Enterprise Institute senior fellow, cautions that a high-value application of artificial intelligence (AI) and artificial general intelligence (AGI) in medicine hinges on their seamless integration into an electronic medical record (EMR), accessing and synthesizing diverse data. He says current FDA policies
Drugs
FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce. He was sentenced to one year of supervised release and ordered to pay $100,000 in forfeiture for selling the drugs through his company, Warrior Labz SARMs and associated Web sites, according
Devices
Sentec/Percussionaire is recalling (Class 1) its Phasitron breathing circuit kits after receiving a complaint that the venturi component stopped oscillating during use, which caused a patient’s oxygen levels to fall. “The risk of failure is especially high for pediatric patients due to the low pressures that are associated
Drugs
Pliant Therapeutics says it has paused enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The pause was recommended following a prespecified data review by the trial’s independent data safety monitoring board.
FDA Policy/General
FDA has released a final guidance entitled “Institutional Review Board (IRB) Written Procedures” that is intended to harmonize FDA and HHS’ Office for Human Research Protections (OHRP) regulatory requirements on clinical trial human subject protections. The document says FDA and OHRP believe that when institutions and IRBs develop and follow
Drugs
Boehringer Ingelheim says it will submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following the company’s reporting of positive data from its FIBRONEER-ILD trial. The study met its primary endpoint, which was the absolute change from baseline in lung function (forced vital capacity) at week 52
Devices
FDA has cleared an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an in vitro diagnostic that uses artificial intelligence to generate heatmaps to identify small and rare missed prostatic cancers. The device was designed to act as a “safety net that assists pathologists in ensuring patients receive
Drugs
FDA has granted Tempest Therapeutics a fast track designation for amezalpat (TPST-1120), a small molecule, selective PPAR⍺ antagonist for treating patients with hepatocellular carcinoma (HCC). The company says the designation is based on positive data across multiple key study endpoints in a global randomized Phase 1b/2 study evaluating
Drugs
Roche says it is sharing with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis (LN). “The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people
Drugs
Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) are urging FDA to take enforcement action against a planned direct-to-consumer (DTC) commercial that will run during the Super Bowl 2/9 which omits safety or side effect information. The commercial promotes Hims & Hers’ compounded version of
Devices
FDA has cleared a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows with an artificial intelligence-powered approach. “Obtaining high-quality 3D images within minutes of a CTA [computed tomography angiography] scan marks a significant advancement and milestone in neuroradiology,