Biologics
A CBER FY 2018 annual summary of biological product and HCT/P (human cells, tissues, and cellular and tissue-based products) deviations reports gives an overview of the types of reports received during the fiscal year, with detailed information about the number and type of deviations reports received. “Each firm
Biologics
FDA says it is confident that AveXis’ Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene, that was approved by the agency 5/24, should remain on the market despite
Biologics
FDA has approved a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbott’s Humira for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Hadlima will be commercialized in the U.S. by Merck, and is expected
Biologics
FDA has approved a Pfizer BLA for Ruxience (rituximab-pvvr), a biosimilar to Biogen’s Rituxan for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Approval was based on the review of a comprehensive data package, which demonstrated
Biologics
A 2/13-2/25 FDA inspection at the Virginia Center for Reproductive Medicine, Reston, VA, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 7/1 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Biologics
FDA has accepted for priority review a Novartis BLA for its investigational sickle cell drug crizanlizumab. The submission seeks approval for preventing vaso-occlusive crises (VOCs) in patients with sickle cell disease. Novartis says that VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic
Biologics
Omeros and FDA have reached agreement on a response-based primary endpoint for its pivotal trial to support a BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab is described by the company as a human monoclonal antibody targeting mannan-binding lectin-associated serine
Biologics
FDA has accepted for review a Sanofi BLA for isatuximab for treating patients with relapsed/refractory multiple myeloma. The investigational monoclonal antibody is designed to target a specific epitope on the CD38 receptor of a plasma cell. The agency has set a user fee review target action date of 4/
Biologics
FDA has approved a Pfizer BLA for Zirabev (bevacizumab-bvzr), a biosimilar to Genentech’s Avastin (bevacizumab), indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or
Biologics
CBER has released a list of 20 guidances it is considering for development in this calendar year. The notice says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft
Biologics
A Florida federal court 6/25 has issued an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, and their chief scientific officer Kristin Comella, from manufacturing or distributing any and all stromal vascular fraction products, which are adipose
Biologics
The Healthcare Distribution Alliance says it commends FDA for issuing a draft guidance on initiating voluntary recalls and the clarity and assistance it offers to recalling firms and their trading partners. It also says the draft is not aligned with Drug Supply Chain Security Act requirements and explains its detailed
Biologics
FDA has approved an Amgen BLA for Kanjinti (trastuzumab-anns), the fifth biosimilar copy of Roche’s Herceptin (trastuzumab). The approval also marks a significant FDA milestone — the 20th biosimilar approved by the agency. This includes at least one biosimilar approved for Avastin, Enbrel, Epogen/Procrit, Herceptin, Humira, Neulasta, Neupogen,
Biologics
The FDA Tissue Reference Group (TRG) is launching a six-month TRG Rapid Inquiry Program (TRIP) to help manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment
Biologics
FDA has granted Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (also known as BR) for treating adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Biologics
Responding to an FDA 5/28 Notice of Violation indicating that R3 Stem Cell, Scottsdale, AZ, was promoting regenerative stem cell therapies without an approved BLA, the company says it is reviewing its Web site and operations and is unaware of any safety issues resulting from stem cell contamination. “R3
Biologics
FDA has accepted for review an Enzyvant BLA for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The agency granted a priority review and
Biologics
Georgia State University law professor Yaniv Heled says a new FDA guidance explaining how drug manufacturers can develop follow-on biologics is a good step toward lowering drug costs, but may not be enough to make a real difference. Writing online for The Conversation, Heled explains why biologics are so
Biologics
A Florida federal court has granted the federal government’s motion for summary judgment against U.S. Stem Cell Clinic and its chief scientific officer for adulterating and misbranding a stem cell drug product made from a patient’s adipose tissue. The Justice Department initiated legal action against the clinic
Biologics
CBER’s Office of Compliance and Biologics Quality has sent an untitled letter to R3 Stem Cell because its Web site promotes its “regenerative stem cell therapies” without an approved BLA. “We note that your products are intended to treat a variety of serious or life-threatening diseases or conditions,
Biologics
FDA has approved an AveXis BLA for Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), a severe form of SMA and a leading genetic cause of infant mortality. FDA says that the rare genetic disease
Biologics
FDA has released a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The document describes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to