Drugs
FDA will give priority review to a Regeneron Pharmaceuticals BLA for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). The company says evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH, including patients with little
FDA Policy/General
Federal Register notice: FDA has announced a 10/2 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” The document recommends content for the marketing status notifications, the format for submitting them, and the timelines for submission. To view the
Drugs
FDA says its testing of Bersih hand sanitizers manufactured by Soluciones Cosmeticas, Mexico City, Mexico, determined that batches of the products were adulterated by including methanol with the ethanol active ingredient. An 8/4 Warning Letter also says the products are unapproved misbranded new drugs. The letter says the firm
Drugs
FDA has issued Fennec Pharmaceuticals a complete response letter on its NDA for Pedmark (sodium thiosulfate), for intravenous administration for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than one month of age with localized, non-metastatic, solid tumors. The agency’s letter cited manufacturing concerns from a
Drugs
A 6/3-6/6/19 FDA inspection at Taka USA, doing business as Cosmetic Innovations, Carrollton, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/29 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate
Devices
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel says FDA has authorized over 200 SARS-CoV-2 tests in the emergency use authorization pathway. Speaking on an 8/5 virtual town hall on development and validation of coronavirus tests, Stenzel said there are “hundreds of EUA
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System. The device is intended for use by surgeons to provide anterior column support through a lateral approach. It includes a comprehensive set of instruments and implants to streamline the surgical procedure, the company
FDA Policy/General
Rep. Raja Krishnamoorthi (D-IL) says that science shows that e-cigarette users are much more likely to be diagnosed with Covid-19 and to experience symptoms. Krishnamoorthi discussed the finding in an 8/11 letter to FDA commissioner Stephen Hahn. In the letter, the representative said he had presented
Devices
Becton, Dickinson (BD) has recalled its ChloraPrep 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territories (Puerto Rico, Guam, U.S. Virgin Islands, Northern Mariana Islands and American Samoa). These warm, high-humidity locations promote the growth of Aspergillus
Drugs
Briefing documents released by FDA in advance of an Oncologic Drugs Advisory Committee 8/13 meeting to consider the Mesoblast BLA for its Remestemcell-L as a treatment for steroid-refractory acute Graft Versus Host Disease (SR aGVHD) in pediatric patients challenge the biologic’s effectiveness and durability of patient
Drugs
Genentech says topline results from a Phase 3 safety program evaluating its investigational etrolizumab in people with moderately to severely active ulcerative colitis gave mixed results in studies evaluating the biologic as an induction therapy. In addition, studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Taka USA, Carrollton, TX (7/29) FDA inspected the company 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Taka failed to have for each batch
Devices
FDA has released updated information on the adverse event information from the first monthly spreadsheet Bayer is required to submit to the agency on its Essure birth control device. An agency notice (includes a link to the spreadsheet) says Bayer is required to submit the spreadsheets under a 4/24
Devices
FDA has approved a Guardant Health PMA for the Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell
Devices
Becton Dickinson (BD) is predicting a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump. On a recent earnings call, BD president Tom Polen told analysts that the 510(k) should be filed in late March of 2021, which is about six months
Drugs
Gilead Sciences has submitted an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19. Remdesivir is currently available in the U.S. under an emergency use authorization for treating hospitalized patients with severe Covid-19. The submission is based on data from two Phase 3 clinical studies that
Drugs
FDA has approved a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults when the pain is severe enough to require an intravenous opioid and alternative treatments are inadequate. The drug is indicated for short-term intravenous use in hospitals or other
Drugs
FDA has made available a guidance entitled “Bioresearch Monitoring Technical Conformance Guide.” The document provides the agency’s current thinking on preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset used by CDER for planning Bioresearch Monitoring
FDA Policy/General
Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to a discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation), indicated for reducing all-cause mortality in patients with chronic obstructive pulmonary
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to provide a systematic, risk-based approach to help sponsors determine the need for drug-drug interaction studies for a therapeutic protein. To view the notice, click here.
Drugs
FDA has made available a guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. It advises NDA/ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale. It also asks them