Biologics
FDA has posted a final guidance 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).” The document updates recommendations for making a donor eligibility determination when screening a donor for clinical evidence of
Drugs
Senators Chuck Grassley (R-IA) and Dick Durbin (D-IL) are urging the Pharmaceutical Research and Manufacturers of America (PhRMA) to support their bipartisan Drug-price Transparency for Consumers (DTC) Act that would require price disclosures on prescription drug advertisements to “empower consumer choice and reduce patients’ bloated spending on
Drugs
Inhibikase Therapeutics says it is pausing further development of risvodetinib, a selective inhibitor of the non-receptor Abelson Tyrosine Kinases and its use in untreated Parkinson’s disease. The company says that recent data from its Phase 2 201 trial did not demonstrate an “improvement in the top hierarchical efficacy
Devices
Nova Biomedical is recalling (Class 1 device correction) its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect glucose or ketone patient test results to be transmitted to hospital medical record systems. “The issue occurs when an operator visits the
Drugs
FDA has cleared a Roche 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The company says the panels include tests for chlamydia and gonorrhea and chlamydia, gonorrhea and Mycoplasma genitalium. They enable clinicians to diagnose and differentiate between multiple STIs with a single sample.
Drugs
Three Hyman, Phelps & McNamara attorneys say the publication of FDA guidances on its new accelerated approval authorities in 12/2024 and 1/2025 provide a framework for how it plans to enforce its requirements that confirmatory trials for products receiving accelerated approval be “underway” and “conducted with due diligence.
Drugs
Merck says it is stopping early the Phase 3 HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo in recently diagnosed adults with pulmonary arterial hypertension (PAH) due to robust results already seen in other studies and a review of the Winrevair clinical program. “The decision to stop the HYPERION study
Drugs
A 7/15-8/2/2024 FDA inspection at the ProRx outsourcing facility in Exton, PA, found evidence that drug products the company produced failed to meet regulatory conditions necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the Federal Food, Drug, and
Devices
An FDA safety communication says that cybersecurity vulnerabilities in certain Contec and Epsimed (relabeled Contec) patient monitors may put patients at risk after being connected to the Internet. The communication says these three vulnerabilities have been identified: * the patient monitor may be remotely controlled by an unauthorized user or not
FDA Policy/General
[Analysis by David McFarland] Senate Health Education Labor & Pensions Committee chair Bill Cassidy (R-LA) is having trouble reconciling HHS secretary-nominee Robert F. Kennedy Jr.’s past positions on vaccine skepticism with his current stance to make America the healthiest country in the world. During his concluding remarks
Drugs
FDA has approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Approval was based on data from the Phase 3 MOMENTUM trial which treated moderate and severe migraine pain, the Phase 3 INTERCEPT trial which treated mild migraine pain, and
Drugs
FDA has cleared a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a), or Lp(a), in nanomoles per liter. The company says Lp(a) is an “under-recognized, potential risk factor for cardiovascular disease due to its ability to promote the
Devices
FDA has granted OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant. The agency has also accepted the device for enrollment in CDRH’s Total Product Life Cycle Advisory Program (TAP). The breakthrough designation covers the implant’s use for treating patients who continue to experience knee
Drugs
FDA has granted orphan drug designation to Marsh Biosciences’ MB-105, described as a first-in-class CD5 CAR-T cell therapy to treat relapsed/refractory CD5-positive T-cell lymphoma. The company says it is developing MB-105 for several CD5-positive hematologic malignancies. It says the therapy employs
Drugs
Adial Pharmaceuticals says it has completed with positive results its pharmacokinetic study of AD04 (ondansetron) for treating alcohol use disorder and will work with FDA on designing a Phase 3 trial. A company statement says the formulation “exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose
FDA Policy/General
The January Kaiser Family Foundation Tracking Poll on Health Information and Trust documents a continuing decline in public trust in government health agencies that began during the Covid-19 pandemic. Trust in FDA has fallen from 65% in 6/2023 to 53% in 1/2025, the poll shows. The Centers
Biologics
Four researchers and scholars who are founding members of the Council for Quality Health Communication say it’s time to unpack what is meant by vaccine safety and effectiveness and acknowledge individual concerns being raised by consumers. Writing in a MedPageToday Perspective column, the four say that many people don’
Drugs
A bipartisan group of nine senators has reintroduced the FDA Modernization Act (FDAMA) 3.0 directing the agency to implement the FDA Modernization Act 2.0 legislation intended to modernize drug testing protocols and improve patient outcomes. A statement issued by Sen. Cory Booker (D-NJ), one of the sponsors,
FDA Policy/General
Robert F. Kennedy Jr. faced heated criticism and questioning from Democrat senators for his stances on vaccines, abortion rights, and conflicts of interest during a 1/29 Finance Committee confirmation hearing for HHS secretary. However, Republican resistance was all but absent at the hearing, which may foretell Senate passage if
Biologics
FDA has accepted for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, Alvotech’s proposed biosimilar to Janssen Biotech’s Simponi and Simponi Aria (golimumab), which are used to treat moderate to severe inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. An FDA action is
Drugs
FDA has approved a new indication for Novo Nordisk’s Ozempic (semaglutide), which the company says makes it the only GLP-1 receptor agonist to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 diabetes and chronic kidney disease. The company says the approval
Devices
FDA has granted Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease. The company says the assay measures the ratio of phosphorylated tau protein (p-