Devices
Medtronic Perfusion Systems has recalled (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the devices may not retain their shape. According to a recall notice, FDA has determined the cause to be related to “process change control.” The single-use cardiovascular surgical catheter is
Drugs
FDA has posted a complex innovative trial case study that evaluated the benefit and risk of a higher dose than previously evaluated in a clinical trial of a drug to treat alopecia areata. The case study says the agency considered these trial design features innovative: * using external and synthetic placebo
Drugs
A 3/10-3/19 FDA inspection at the Amneal Pharmaceuticals drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/27 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
FDA Policy/General
Calls for HHS secretary Robert F. Kennedy Jr. to leave office are intensifying. Over a thousand current and former staff at FDA, CDC, and NIH have joined a new open letter to Kennedy and Congress, calling for Kennedy to resign or be fired. "We warn the President, Congress, and
Biologics
CBER director Vinay Prasad demanded that YouTube videos in which he criticized the Covid-19 vaccines be removed. The videos were part of some 350 clips of doctors and commentators that were posted on the YouTube channel maintained by Jonathan Howard, a New York City neurologist and psychiatrist, according to
Drugs
FDA has granted Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) mutations. The designation is supported by data from the ongoing Beamion-LUNG 1 trial, which
Drugs
FDA has launched its Rare Disease Evidence Principles (RDEP) process to “provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.” An agency statement says that
Biologics
Memos posted on FDA’s Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination approvals. For example, as part of the agency’s approval last week of the upcoming Covid-19 seasonal vaccines, Prasad wrote in one memo that CBER
Drugs
FDA has accepted for review an Achieve Life Sciences’ NDA for cytisinicline, an investigational treatment for nicotine dependence. The submission has been assigned a user fee review action target date of 6/20/2026. The NDA is based on data from more than 2,000 clinical trial participants enrolled in
Drugs
Drug developers are using artificial intelligence (AI) technologies for discovery and safety testing to get faster and cheaper results and help reduce the dependence on animal testing. That’s the view of several experts interviewed by Reuters for a story on AI-driven drug development. “Within the next three to
Drugs
A 2/24-3/5 FDA inspection at Chromatography Institute of America, doing business as Compounder’s International Analytical Laboratory in Castle Rock, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and significant deviations from CGMP for active pharmaceutical ingredients. An 8/20 Warning
Drugs
FDA has published its 2025 annual forecast for planned OTC drug monograph activities. The non-binding list shows planned monograph activities the agency intends to initiate over the next three years. Topics of planned monograph activities listed in the 2025 forecast are: * risks associated with codeine-containing cough medicine; * pediatric
Biologics
FDA has approved two new denosumab biosimilars from Shanghai Henlius Biotech and Organon, ostensibly expanding patient access to treatments for osteoporosis and cancer-related bone conditions. The products, Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), are said to be highly similar to Amgen’s blockbuster drugs Prolia and Xgeva, respectively.
Drugs
Merck’s investigational oral PCSK9 inhibitor enclicitide decanonate met all its primary and secondary endpoints in the Phase 3 CORALreef Lipids trial evaluating the drug to treat adults with hypercholesterolemia on a moderate or high-intensity statin. A company statement says treatment with enlicitide resulted in statistically significant and clinically
Drugs
FDA has released the form FDA-483 with four observations from a 7/29-8/8 inspection at AnazaoHealth, a Las Vegas, NV, outsourcing facility. The four inspection observations were: * failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity,
Drugs
FDA’s vast responsibilities — regulating and monitoring everything from drug and device safety to the food supply and cosmetics — make it one of the most important federal agencies. Yet former Alliance for a Stronger FDA executive director and now regulatory expert and author of the blog FDA Matters (www.fdamatters.
Drugs
A 3/3-3/7 FDA inspection at the Wisconsin Pharmacal drug manufacturing facility in Jackson, WI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/22 Warning Letter says the specific violations were: * failure of the quality control unit to exercise its responsibility
Biologics
FDA has agreed to accept a biosimilar application that does not include clinical efficacy studies (CESs) for a monoclonal antibody, a step that could dramatically change how these drugs are developed and approved. The upcoming submission from University of Illinois adjunct professor and founder of several biopharmaceutical ventures Sarfaraz K.
Devices
FDA has cleared a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbott’s Instinct continuous glucose monitoring (CGM) sensor for people with Type 1 diabetes. The Instinct device, designed exclusively for Medtronic’s automated insulin delivery systems, is the smallest and thinnest integrated CGM
Biologics
FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Children’s Hospital of Philadelphia’s Vaccine Education Center director Paul Offit reportedly is the first to go. Offit has often been a critic of HHS secretary Robert F. Kennedy Jr. and his health policies.
Drugs
Johnson & Johnson has halted development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis (RA) after a mid-stage proof-of-concept study failed to show added benefit. The Phase 2a DAISY trial tested nipocalimab, an anti-FcRn antibody, alongside a tumor necrosis
Drugs
Novocure has terminated its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields (TTFields) together with Merck’s Keytruda (pembrolizumab) in metastatic non-small cell lung cancer (NSCLC) patients previously treated with a PD-1/PD-L1 inhibitor and platinum chemotherapy. The company notified trial sites