Drugs
FDA says it is requiring updates to the Boxed Warning and other information for prescription stimulants to ensure the prescribing information is consistent across the entire class of drugs, The drugs are used to treat attention deficit/hyperactivity disorder, binge-eating disorder, and narcolepsy. An agency notice says the current
Biologics
The National Organization for Rare Disorders (NORD) says it applauds FDA efforts to seek extensive comments and community engagement on post-market surveillance for cell and gene therapy products, and greatly appreciated the April public listening session on the topic. The NORD comment letter discusses these topics with recommendations: * post-
FDA Policy/General
Federal Register notice: FDA has determined that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Heparin sodium Injection is an anticoagulant
Devices
Germany-based Berlin Heart has recalled (Class 1) its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disruption. “There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device,” a recall notice says. The recall
Drugs
FDA has accepted for priority review a Takeda and Hutchmed NDA for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for treating adult patients with previously treated metastatic colorectal cancer (CRC). If approved, the companies say fruquintinib will be the
Devices
Neuralink, the neurotechnology company owned by Elon Musk, says it has gained FDA approval for a human clinical trial of its brain implant technology. The agency has not commented publicly on the reported approval or specified what it includes, according to a UPI report. In March, Reuters reported it had
Drugs
FDA has approved a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The
FDA Policy/General
Federal Register notice: FDA has determined that Purdue Pharma’s Chirocaine (levobupivacaine) injection (multiple strengths) was not withdrawn due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the notice,
Drugs
Mirati Therapeutics says the Phase 3 SAPPHIRE study that evaluated sitravatinib with Bristol-Myer Squibb’s Opdivo (nivolumab) versus docetaxel in select patients with second- or third-line advanced non-squamous non-small cell lung cancer failed to meet its primary endpoint of overall survival at the final analysis. The
Devices
FDA has published a guidance, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures, with recommendations it says may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. The document says tissue containment
Drugs
FDA has published a guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, with current agency recommendations on adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. The document provides recommendations for using covariates in the analysis of randomized parallel
Drugs
Drug recalls surged by 53.2% from 94 in the fourth quarter of 2022 to 144 in the first quarter of 2023, according to the Sedgwick first quarter recall index. The report says current good manufacturing practice deviations dominated the recall activity, accounting for 70 events and 33.2 million
Drugs
FDA has granted Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropathy (PMN). The monoclonal antibody is designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies, the company says. PMN is a rare
Drugs
The 13 House members from Michigan have sent a bipartisan letter to FDA commissioner Robert Califf urging the agency to take immediate action to mitigate the effects of a nationwide shortage of chemotherapy drugs. Led by Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI), the delegation letter says
Drugs
FDA has approved a Pfizer NDA for its antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Paxlovid was granted an emergency use authorization (EUA) 12/2021, which is
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.” The document is intended to assist sponsors in determining when it may be appropriate to rely on generally accepted scientific knowledge to fulfill certain legal and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers.” The question-and-answer document is intended to clarify FDA’s recommendations on managing, documenting and using whole slide images in histopathology assessments and pathology peer review
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site and YouTube channel maintained by AT Venture Center for Global Techtrepreneurship, doing business as Regenerelle in Fairport, NY, determined that the firm is marketing a human mesenchymal stem cell product intended to treat various diseases
Devices
Integra LifeSciences says it is recalling all products manufactured at its Boston, MA facility due to inadequate endotoxin testing. An internal investigation found deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications, the company says
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say they commend FDA for publishing a framework to guide the use of digital health technology (DHT)-derived data in regulatory decision-making for drug and biological products. The associations’ joint letter recommends that the agency consider
FDA Policy/General
Federal Register notice: FDA is announcing a 6/28 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Ipsen Biopharmaceuticals NDA for palovarotene capsules, indicated for preventing heterotopic ossification in adults and children (females aged eight years and above and males 10 years and above)
Drugs
Phathom Pharmaceuticals says it has resubmitted to FDA an NDA for vonoprazan, a novel first-in-class potassium-competitive acid blocker to treat erosive gastroesophageal reflux disease (erosive esophagitis). The company says the resubmission responds to an agency 2/2023 complete response letter relating to specifications and controls for a