Drugs
CDER researchers say clinical pharmacologists face an unprecedented timeline for Covid-19 drug development, optimizing dose and dosing regimens for repurposed drug products to be evaluated in clinical trials. Writing in the Journal of Clinical Pharmacology, the FDAers summarize the clinical pharmacy considerations in the development of immunomodulatory therapeutic proteins
Drugs
FDA has issued a guidance, Male Breast Cancer: Developing Drugs for Treatment, with recommendations for sponsors on the development and labeling of cancer drugs, including biological products, regulated by CDER and CBER for treating male patients with breast cancer. The document says the historic exclusion of males from breast cancer
Drugs
FDA has approved a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity. The product is described by the companies as a next generation activation device designed specifically for Definity Vial (perflutren lipid microsphere) for injectable suspension, an intravenous ultrasound enhancing agent. “Definity is supplied as a liquid-
Drugs
An FDA drug safety alert is warning about reports of toxic anterior segment syndrome (TASS) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged or diluted FDA-approved moxifloxacin. The agency has identified 29 cases
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
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
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,
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
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
Drugs
FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach. When evaluating the potential for a DDI, FDA
Drugs
FDA has approved Genentech’s Evrysdi (risdiplam) for treating spinal muscular atrophy (SMA) in adults and children two months of age and older. SMA is a rare and often fatal genetic disease affecting muscle strength and movement. The hereditary disease causes weakness and muscle wasting because patients lose lower motor
Drugs
California has reached a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab), indicated for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. “AbbVie agreed to reform its Humira marketing practices
Drugs
FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for treating HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
Drugs
The FDA FY 2019 annual report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) shows that the majority of the requirements and commitments were completed or are moving toward completion according to the original schedule. “Very few PMRs/PMCs are ‘delayed,’” the agency says in a statement
Drugs
The Rare Disease Clinical Trial Network (RDCRN) funded by the National Institute of Health says there is a need for a Rare Disease Clinical Trial Resource Center that could be leveraged by existing research networks or consortia doing global clinical research in rare diseases. The recommendation is part of the
Drugs
FDA has granted GlaxoSmithKline accelerated approval for Blenrep (belantamab mafodotin-blmf) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Approval was based on data from the DREAMM-2,
Drugs
Ferring Pharmaceuticals has recalled all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate (desmopressin) nasal spray 1.5 mg/mL. The products are being recalled due to superpotency concerns, an out-of-specification result detected during routine testing.