Biologics
Figures released by FDA show that the agency performed about 2,500 human cells, tissues, and cellular and tissue-based products inspections in fiscal years 2012-2016. The online chart lists the total number of inspections per year with the average number of hours per inspection, and the number of
Biologics
FDA has accepted for priority review a Kite Pharma BLA for axicabtagene ciloleucel for treating non-Hodgkin lymphoma. The submission is based on data from the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma. The trial met the primary endpoint of objective response rate (82%
Biologics
CBER Office of Compliance and Biologics Quality has cited the unnamed owner of a Web site (http://www.americanpumpkins.com) for promoting its In Home Blood Test for HIV 1 and 2 and the Oral In Home Saliva Test for HIV 1 and 2. A just-posted agency letter says
Biologics
Amgen has submitted a BLA for erenumab to prevent migraine. The human monoclonal antibody works by blocking the Calcitonin Gene-Related Peptide receptor. according to the company. The submission includes data from pivotal studies in patients with episodic and chronic migraine, it says. “The erenumab global clinical trial program has
Biologics
Spark Therapeutics has completed a rolling BLA submission for voretigene neparvovec, an investigational, one-time gene therapy for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal disease. The filing includes data from three clinical trials that enrolled 41 participants with the retinal disease, including the
Biologics
FDA has granted Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA (cDNA) gene therapy candidate for hemophilia A, which is being developed as part of a collaboration and license agreement with Pfizer. SB-525 uses a recombinant adeno-associated virus to deliver a human
Biologics
FDA has issued a guidance, Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), to provide agency recommendations for testing living donors for West Nile Virus using an FDA-
Biologics
FDA has approved a Sanofi and Regeneron Pharmaceuticals supplemental BLA for a once-monthly, 300 mg dose of Praluent (alirocumab) injection for treating adults with high low-density lipoprotein (LDL) cholesterol. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial
Biologics
FDA has approved a Samsung Bioepis abbreviated BLA for Renflexis (infliximab-abda), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. This is the second biosimilar referencing Remicade to receive approval; Celltrion and Hospira gained approval
Biologics
FDA has told Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the company’s BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)], a vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The agency has
Biologics
FDA has licensed eight Quotient Limited rare antisera blood typing reagent products that are intended for use in transfusion diagnostics, and formulated specifically for antigen phenotyping. The products are the most frequently used for special antigen testing by customers, and cover Fy [a ] and Fy [b ] ; S and s; Kell;
Biologics
FDA has granted Humacyte a Regenerative Medicine Advanced Therapy (RMAT) designation for the company’s investigational human acellular vessel Humacyl. The designation was created under the 21st Century Cures Act to help speed development of a regenerative medicine therapy (e.g., cell therapy, therapeutic tissue engineering product, human cell and
Biologics
FDA has granted DynPort Vaccine Co. an orphan drug designation for a plague vaccine being developed on behalf of the Defense Department. The recombinant rF1V product is intended to be used for pre-exposure prophylaxis to combat infection with Yersinia pestis, the causative agent of plague. The vaccine is being
Biologics
FDA has accepted a Dynavax Technologies submission that addresses an 11/2016 Complete Response Letter (CRL) for its BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)], a vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The agency has set a user
Biologics
A new National Academies book, Human Genome Editing: Science, Ethics, and Governance, says that FDA is one of several agencies and organizations that have a significant role in regulating both somatic and germline human genome editing. The publication says that human genome therapies are considered to be gene therapies with
Biologics
FDA has accepted for priority review a Pfizer BLA for inotuzumab ozogamicin for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received a Breakthrough Therapy designation from the agency 10/2015. The user fee review target date is expected in August. The
Biologics
FDA has accepted a Mylan and Biocon BLA for MYL-1401H, a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim), indicated for reducing the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with
Biologics
Amgen has filed a supplemental BLA for Blincyto (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study, supporting the conversion of the product’s accelerated approval to full approval. The company says the supplement also includes new data supporting the treatment of patients with Philadelphia chromosome-
Biologics
FDA has accepted for review a CSL Behring clinical efficacy supplement on its BLA for to Privigen [immune globulin intravenous (human), 10% liquid], its intravenous immunoglobulin. The supplement seeks to obtain approval for a new indication — treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressing disease that may
Biologics
FDA has granted Angionetics a Fast Track designation for Generx [Ad5FGF-4], a cardiovascular angiogenic gene therapy for use as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass
Biologics
Sanofi says it will resubmit a joint BLA submission with Regeneron Pharmaceuticals for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In October, FDA sent the companies a Complete Response Letter on their BLA, citing certain deficiencies identified during a
Biologics
FDA has accepted for review two Merck supplemental BLAs for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and granted priority review for treating patients who are ineligible for cisplatin-containing