Drugs
FDA’s Endocrinologic and Metabolic Diseases Advisory Committee has voted 16 to 0 to recommend approval for Amarin’s submission to expand Vascepa’s (icosapent ethyl) indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk
Devices
FDA has cleared a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will reduce the number of parts that need to be cleaned and disinfected in between uses. The Pentax Medical Video ED34-i10T2 is intended to provide visualization and access
Drugs
FDA has approved a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis — a sickle cell disease-related common and painful complication that occurs when blood circulation is obstructed by sickled red blood cells. “Adakveo is the first targeted therapy approved for sickle cell disease,
Drugs
FDA has approved a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. Approval is based on
Drugs
FDA has issued a final guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention” to assist drug manufacturers designing studies to evaluate safety and efficacy of such drugs. The agency notes that smallpox was declared eradicated in 1980, but “concerns exist that it could remain in unknown
Drugs
FDA has awarded $1.7 million to five universities to fund a two-year, wide-ranging research project intended to help the agency better understand how to employ its quality management resources when inspecting drug company manufacturing operations. Schools participating the project are Indiana University, Ohio State University, University of
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.” The document describes the information that the agency will provide to a person whose request for a Certificate to Foreign Government for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims” (OMB Control Number 0910-0670). The guidance encourages the submission of supplemental labeling and is intended to assist applicants in developing labeling for outcome claims for such drugs. To
Devices
FDA has cleared an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans. Traditional echocardiography relies on the “expert eye” of clinicians to identify disease under a time-consuming and highly variable process,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). This regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies
Drugs
FDA has issued a Warning Letter to Dollar Tree discount stores for receiving over-the-counter drug products produced by foreign manufacturers that were found to have “serious violations of federal law.” The letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce the company’
Drugs
FDA has accepted for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs). The agency is expected to set a second quarter 2020 user fee review action target date, the companies say
Drugs
CGMP consultant Dave Elder says an International Conference on Harmonization draft guidance for product lifecycle management, currently at stage 2b, is intended to extend the use of Quality by Design to established products and thus supplements the existing Quality by Design guidance that has been published for drug substances and
Devices
Retired CDRH branch chief Morris Waxler, who voted to approve LASIK eye surgery when he worked for the agency, now tells CBS News the vote was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler told the
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 14 to 2 to not recommend approval of Eli Lilly and Boehringer Ingelheim’s empagliflozin 2.5 mg because the drug’s benefits do not outweigh its risks as an adjunct to insulin for adults with Type 1 diabetes. The
Drugs
FDA says it has formally convened the Botanical Safety Consortium (BSC) under a memorandum of understanding signed between the agency, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute. The memorandum established the framework for the BSC, FDA says. The consortium’s mission is to
Drugs
FDA says it has approved BeiGene’s Brukinsa (zanubrutinib) capsules for treating adult patients with mantle cell lymphoma who have received at least one prior therapy. Brukinsa was approved on the basis of a clinical trial of 86 patients with mantle cell lymphoma who had received at least one prior
Drugs
FDA has released the FDA-483 issued following a 9/1-9/18 agency inspection at Isorx Corp., a Richmond, CA, producer of sterile and non-sterile drugs. The four inspection observations were: * failing to disinfect materials or supplies before entering the aseptic processing areas; * disinfecting agents and cleaning wipes
Devices
FDA has cleared a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden (TMB) in cancer tissue. The company describes the assay as the first “custom-targeted whole exome sequencing platform to report both overall tumor mutation burden
Drugs
FDA has granted X4 Pharmaceuticals a breakthrough therapy designation for mavorixafor for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company described mavorixafor as a potential first-in-class,
Drugs
FDA has placed a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The company says the agency “reviewed our submission and requested
Drugs
Researchers from Harvard Medical School and other institutions say FDA should update and revise existing guidances for anti-infective drug approvals to recommend appropriate clinical outcomes consistent with general scientific and regulatory parameters. Writing online in JAMA Internal Medicine, the researchers say that 21 of 27 guidances reviewed recommended surrogate