Biologics
FDA says an investigational test is available for use under an IND to screen donated blood in areas with active mosquito-borne transmission of Zika virus. An agency news release says that the Roche Molecular Systems test was developed in close collaboration with FDA. In a 2/18 guidance to
Biologics
Biotechnology Innovation Organization (BIO) has urged FDA to state explicitly in a planned final guidance on “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application” that repackaged biological products should satisfy the same sterility requirements in place for products manufactured under approved BLAs. In
Biologics
FDA’s costs for implementing its biosimilars program jumped almost 40% last year after the first application was reviewed and approved, according to a new independent report commissioned by the agency. The report was mandated by the biosimilars user fee program to study the workload volume and full costs associated
Biologics
FDA has issued a guidance, Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, to give establishments that manufacture human cells, tissues, and cellular and
Biologics
FDA says that due to considerable interest in a scheduled 4/13 public hearing on a draft guidance relating to regulation of human cells, tissues, or cellular- or tissue-based products, it is extending the comment period for the draft guidance documents and postponing the hearing until later this year.
Biologics
FDA has issued new guidance recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational
Biologics
FDA has accepted for review a Genentech supplemental BLA for an expanded indication for Xolair (omalizumab) in pediatric patients with allergic asthma. The review will evaluate Xolair’s use in children aged six through 11 years for treating moderate to severe persistent asthma in those patients with a positive skin
Biologics
FDA has approved a Genentech supplemental BLA for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most common
Biologics
A lengthy and detailed report from the George Mason University Mercatus Center says that FDA has strayed from the drug, biologic, and medical device safety and effectiveness standards set out in the law due to “fear of being blamed for the failings of approved products.” The agency now, it says,
Biologics
CBER has accepted for priority review a Portola Pharmaceuticals BLA for andexanet alfa, indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The user fee review target date is 8/17. Portola says the therapy should be used to reverse anticoagulation, such as in life-threatening
Biologics
CBER director Peter Marks says that the Center’s Laboratory Quality System (LQS) program is an international leader in biological product regulation based on demonstrated expertise in laboratory techniques. Writing in an FDA Voice blog post, Marks says the LQS “is the coordinated structure, procedures, processes, and resources that the
Biologics
FDA has issued a new guidance recommending blood donor deferrals for those who have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. “The FDA has critical responsibilities in outbreak situations and has been working rapidly
Biologics
FDA’s Arthritis Advisory Committee has voted 21 to 3 to support the approval of Celltrion’s proposed biosimilar CT-P13 after finding it highly similar to Janssen’s Remicade (infliximab). Panel members agreed with agency reviewers’ assessment that CT-P13 was highly similar, notwithstanding minor differences in clinically inactive
Biologics
FDA reviewers have concluded that Celltrion’s proposed biosimilar (CT-P13) is highly similar to Janssen’s Remicade (infliximab), notwithstanding minor differences in clinically inactive components. This finding was summarized in briefing documents released in advance of a 2/9 advisory committee review on the latest biosimialr product to obtain
Biologics
FDA has granted TapImmune a fast track designation for its cancer vaccine TPIV 200 and its use in treating ovarian cancer. The designation covers the use of multiple-epitope folate receptor alpha peptide vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian
Biologics
FDA has issued Telesta Therapeutics a complete response letter on its BLA for MCNA (Mycobacterium phlei cell wall-nucleic acid complex), indicated for treating high risk non-muscle invasive bladder cancer patients who have failed front line Bacillus Calmette-Guerin therapy. The agency’s letter indicated that an additional Phase
Biologics
Ortho Clinical Diagnostics has recalled RhoGAM Ultra-filtered PLUS [rho (d) immune globulin (human)] due to a shipping error which resulted in packaging with non-English labeling. A recall notice says use of this product may result in an administration error or use where contraindicated because the label and package
Biologics
FDA has accepted for review a Merck BLA for bezlotoxumab, an investigational antitoxin for preventing Clostridium difficile (C. difficile) infection recurrence. The agency has granted a priority review, with a user fee review target date of 7/23. The submission based in part on data from the pivotal MODIFY I
Biologics
FDA has accepted for review an Amgen BLA for ABP 501, a biosimilar candidate referencing AbbVie’s Humira (adalimumab), indicated for treating chronic inflammatory conditions, such as rheumatoid arthritis, plaque psoriasis and Crohn’s disease. The submission is based on analytical, clinical and pharmacokinetic data, according to Amgen. It says
Biologics
South Korea-based Green Cross Corp. has filed a BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), indicated for treating primary immunodeficiency diseases (PID). The company expects a user fee review target in the fourth quarter. The submission is based on Phase 3 data that demonstrated positive
Biologics
FDA has accepted for review an AstraZeneca and Valeant Pharmaceuticals BLA for brodalumab injection, a monoclonal antibody that targets the IL-17 receptor for treating patients with moderate-to-severe plaque psoriasis. The agency has set a user fee review target date of 11/16. The submission is supported by
Biologics
CBER has published a list of 11 guidances in three categories that it is considering for development in the 2016 calendar year. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topic for which the Center has already issued