Devices
FDA has issued a Warning Letter to Kabe Labortechnik, the North Rhine-Westphaia, Germany-based manufacturer of the RAM Scientific SAFE-T-FILL Capillary Collection System tubes distributed by ASP Global that are linked to a safety alert issued last month on reports of falsely elevated (false positive) results that
FDA Policy/General
Harvard University Department of Health Policy and Management professor Benjamin Sommers says Congress should use the current budget debate to “act as a brake on the administration’s layoffs. Current federal budget negotiations offer an opportunity for legislators who are concerned about the loss of expertise and investments in science
FDA Policy/General
Prothena says it will discontinue the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet the primary or secondary endpoints in a Phase 3 clinical trial. AL amyloidosis, which also known as immunoglobulin light chain amyloidosis, is a condition where abnormal protein deposits (amyloid)
Biologics
HHS is removing CDC Covid-19 vaccine recommendations for healthy children and healthy pregnant women from the agency’s recommended immunization schedule. In a post on X, HHS secretary Robert F. Kennedy Jr., FDA commissioner Marty Makary and NIH director Jay Bhattacharya complained that the Biden administration urged the vaccines
Drugs
FDA has placed a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following the death of a participant who experienced serious complications during the study. The patient developed a serious adverse event (SAE)related to capillary leak syndrome,
Devices
FDA has given 510(k) clearance to the Olympus EZ1500 series endoscopes that the company says feature extended depth of field (EDOF) technology. A company statement says the series’ gastroscope and colonoscope “represent Olympus’ most advanced imaging and latest innovation as part of the EVIS X1 endoscopy system. By allowing
Drugs
FDA has issued a Refusal-to-File (RTF) letter for a Savara BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency concluded that the submission was not sufficiently complete to permit a full review, citing the need for additional chemistry, manufacturing, and controls
FDA Policy/General
FDA has granted an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. Interchangeability now includes a prefilled syringe (40mg) and autoinjectors (40mg and 80mg). The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription
Devices
BD has recalled (Class 1 device correction) its Esophagogastric Balloon Tamponade Tubes to update the device’s instructions for use due to difficulties in removing plastic plugs from its rubber lumen to inflate the balloons. In some cases, the devices may become damaged during removal of the plastic plugs in
Drugs
FDA has approved Liquidia’s Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Yutrepia is designed to “enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort,” the company says. Approval was
Drugs
FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. “It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with
Biologics
FDA says it is advising Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Covid strain for booster shots beginning in the fall (2025-2026). The recommendation followed a 5/22 Vaccines and Related Biological Products
Drugs
Gilead Sciences is announcing promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for immunotherapy. The data show that Trodelvy significantly improved progression-free survival compared to standard chemotherapy, marking
FDA Policy/General
Northern California federal judge Susan Illston has extended by two weeks a preliminary injunction halting the Trump administration’s plans for further reductions in force at FDA and 21 other federal agencies while the case is being appealed. The late 5/22 decision is in response to lawsuits filed by
Devices
Centerline Biomedical has recalled (Class 1) its Intra-Operative Positioning System’s (IOPS) Guidewire 2, a sensorized wire used to navigate through a patient’s vasculature to help accurately place a catheter. A recall notice says that the company has determined that the coating on the guidewires for lot# 2404-
Drugs
“The health of American children is in crisis.” That’s the premise of a report, “Make Our Children Healthy Again: Assessment” issued by the President’s Make America Healthy Again Commission. The report says it “presents the stark reality of American children’s declining health, backed by compelling data and
Drugs
FDA commissioner Marty Makary was pressed by lawmakers during a Senate appropriations hearing over the Trump administration’s secrecy about the agency’s fiscal year 2026 budget proposal, which calls for a $400 million (11.5%) cut in budget authority, and the instability at the agency caused by an over
FDA Policy/General
A Government Accountability Office (GAO) technology assessment report on human organ-on-a-chip (OOC) technologies says an issue facing the development of such technologies is unclear guidance and messaging from FDA. The report says OOC is an emerging technology that incorporates human adult cells in a small laboratory device
Devices
FDA says it has determined that biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institute of Soochow University dba SDWH have in several instances copied the results of another study or created falsified or otherwise invalid data that were submitted to the agency. Until the firms
Devices
A 9/23-10/4/2024 FDA Bioresearch Monitoring Program inspection at United Health Products in Mt. Laurel, NJ, identified serious violations in the firm’s conduct of research involving the CelluSTAT absorbable hemostat. A just-released 3/24 Warning Letter says the specific violations were: * failure to submit an
FDA Policy/General
A Friends of Cancer Research online analysis of data from the FDA accelerated approval (AA) program says it “remains a critical tool for expediting access to promising drugs in areas of unmet clinical need.” The majority of AAs (54%) ultimately receive full approval, the report says, with verification of benefit
Drugs
A HuffPost analysis says that if President Donald J. Trump follows through with planned tariffs on pharmaceuticals, “these largely foreign-made drugs would be targeted with tariffs, potentially causing unexpected shortages and making your doctor’s visit look much different in the future.” The online post quotes University of Utah