Biologics
FDA has approved a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for treating adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is a monoclonal antibody that binds to the CD38
Biologics
FDA has accepted for review a Genentech BLA for a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy, for treating eligible patients with HER2-positive breast cancer. The submission is based on data from the Phase 3
Biologics
CBER has released its Guidance Agenda showing 21 topics the Center is considering for guidance development during calendar year 2020. The document 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
Biologics
FDA has accepted for priority review a Bristol-Myers Squibb BLA for lisocabtagene maraleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for treating adult patients with relapsed or refractory large B-cell lymphoma after
Biologics
Senior CBER officials and executives from BrainStorm Cell Therapeutics have agreed on a potential regulatory pathway for the company’s NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The company says that repeated intrathecal administration of NurOwn is currently being evaluated in
Biologics
Two U.S. senators have asked FDA whether it has the necessary resources to ensure active pharmaceutical ingredients and other medical products and food imported from China are safe in light of the current coronavirus outbreak. In a 2/6 letter to FDA commissioner Stephen Hahn, senators Marco Rubio (R-
Biologics
FDA has issued a guidance, Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II), to provide blood collection establishments agency recommendations on the use of serological tests to reduce the risk of transmission of human T-lymphotropic
Biologics
Former FDA commissioner Scott Gottlieb says that while he doesn’t expect the U.S. to see an epidemic level of coronavirus cases, he does see the deadly virus further spreading across the nation, and globally he expects it to get worse. Appearing on CNBC’s Squawk Box 2/5,
Biologics
A 9/16-9/25/19 FDA inspection at R&B Medical Group, Van Nuys, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/P) in the company’s work as a testing laboratory that performs communicable disease testing under contract
Biologics
A California federal judge has denied an FDA request for summary judgment in its case against a network of clinics that the government says is offering customers unauthorized stem cell treatments. FDA had wanted to shut down activities at the California Stem Cell Treatment Center and the Cell Surgical Network,
Biologics
FDA has approved a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Approval was based on data from two
Biologics
Ultragenyx Pharmaceutical and Kyowa Kirin have submitted a supplemental BLA for Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized. The companies say that about half of patients with TIO have tumors that cannot be surgically
Biologics
FDA has granted Meissa Vaccines a fast track designation for MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. RSV is the most common cause of acute lower respiratory tract infections in young children and infects nearly all children by two years of
Biologics
CBER director Peter Marks’ annual report for FY 2019 says the Center approved a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the blood supply, among other products. The Center approved Zolgensma, the report says, a gene therapy for pediatric patients less than two years
Biologics
FDA has accepted for review an Immunomedics resubmitted BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In 01/2019, FDA issued a complete response letter on the original submission. “The
Biologics
Mesoblast has submitted as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed later this month and Mesoblast says it will request an expedited review. The
Biologics
Verax Biomedical is asking that FDA: * refrain from clearing, approving, recommending, or issuing a “safety measure” designation for large volume delayed sampling (LVDS) as a single step bacterial culture technology for dating beyond Day 5 without first obtaining statistically conclusive data supporting the safety and effectiveness from clinical evidence on
Biologics
A report by the Alliance for Cell Therapy Now says there is a need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for National Institutes of Health research and expanded capacity at FDA to support the rapidly growing field. The
Biologics
Sesen Bio has begun a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer. The company says it has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls (CMC) module. It expects to complete the BLA submission with the finalization
Biologics
FDA appears to be stepping up its enforcement efforts against violative cell/tissue products. On 12/6, the agency warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC (Yorba Linda, CA) for processing and distributing unapproved products derived from umbilical cord blood. They were warned also on current good tissue
Biologics
The CBER Office of Compliance and Biologics Quality says Chara Biologics, Woodland Hills, CA, is marketing its unapproved CharaCore product to consumers, including parents of children with autism. According to an FDA letter to the company, the firm’s Web sites say that CharaCore contains “umbilical, cord tissue, and amniotic
Biologics
FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI) (San Juan, PR) to immediately stop manufacturing cell/tissue products after an October inspection found significant violations. In an 11/25 letter to GREFI, the agency says it does not provide adequate protections against the risks of communicable disease transmission