Biologics
CBER has posted eligibility criteria for qualifying a product as a “regenerative advanced therapy” (RAT) and an accelerated approval pathway as mandated by the 21st Century Cures Act, which was signed into law last month. According to the Center, a product can be eligible for this pathway if: * The drug
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Actemra (tocilizumab) for treating giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The submission is based on “positive outcome” data from a Phase 3 called GiACTA that evaluated Actemra in people with GCA, according to the
Biologics
FDA has posted a response to three citizen petitions that offered recommendations on biosimilar nonproprietary naming policies culminating in its final guidance on Nonproprietary Naming of Biological Products, which requires biological products to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under
Biologics
CBER says it is considering developing 14 guidances in three categories during calendar year 2017. 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 drafts that may be finalized following
Biologics
New CBER director Peter Marks says that in FY 2016, the Center enhanced its operational efficiency, which facilitated getting new treatments to the public. In an annual report, Marks says that as of 9/30/16, CBER exceeded its regulatory performance target by completing 100% of standard and priority reviews
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant)
Biologics
Janssen Biotech has submitted a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. The human monoclonal antibody, which targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the U.S. for treating adults
Biologics
The U.S. acting solicitor general is recommending that the Supreme Court hear appeals by Amgen and Sandoz on the implementation of portions of the Biologics Price Competition and Innovation Act (BPCIA). In an amicus brief, the acting solicitor general says that a Federal Circuit Court of Appeals conclusion that
Biologics
Kite Pharma has begun a rolling BLA submission for KTE-C19 (axicabtagene ciloleucel) as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant. The submission is supported by data from the company’s pivotal ZUMA-1 study
Biologics
FDA commissioner Robert Califf and two agency colleagues say that while the agency is committed to facilitating development and ultimate licensure of safe, effective stem-cell therapies, the lack of scientific evidence in some claims is “worrisome.” Writing in the New England Journal of Medicine, Califf et al say that
Biologics
CBER has sent San Diego-based Dr. PRP America an untitled letter over the unapproved marketing of its medical device Dr. PRP Kit for Platelet Rich Plasma (PRP) separation. The letter comes after the Center reviewed the company’s Web site www.drprpamerica.com on 11/2 and found violative
Biologics
FDA has issued Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), intended for treating primary immunodeficiency diseases. The letter asks for additional information related to chemistry, manufacturing and controls, according to the company, and it did not cite
Biologics
Amgen and Allergan have submitted a BLA for ABP 215, a biosimilar copy of Genentech’s Avastin (bevacizumab), a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting
Biologics
FDA has sent Dynavax Technologies a Complete Response Letter (CRL) on its BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The letter seeks clarification about “specific adverse events of special interest” (AESIs), and a numerical imbalance in
Biologics
Mylan has submitted a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentech’s Herceptin), indicated to treat certain HER2-positive breast and gastric cancers. The submission includes a comprehensive package of analytical similarity, nonclinical and clinical data, the company says. The clinical data consist of two pharmacokinetic
Biologics
CBER says it has undergone an internal restructuring as of 10/16 intended to allow it to more efficiently accomplish its regulatory mission. The new structure includes an Office of Blood Research and Review, an Office of Vaccines Research and Review, and an Office of Tissues and Advanced Therapies (formerly
Biologics
The Center for Biologics Evaluation and Research interim strategic plan for 2017-2019 includes five overarching program goals and a sixth cross-cutting goal. Center director Peter Marks identifies the goals as: * increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious
Biologics
FDA has approved a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults 50
Biologics
FDA has granted Gamida a breakthrough therapy designation for its NiCord cellular therapy based on data showing improvement in absorption of neutrophils blood cells in bone marrow transplant for patients with high risk hematological malignancies (blood cancers). NiCord is an ex vivo expanded cell graft, utilizing Gamida’s proprietary NAM
Biologics
FDA has accepted a Coherus BioSciences BLA for CHS-1701, a pegfilgrastim (Amgen’s Neulasta) biosimilar candidate. The product is indicated for helping to reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer
Biologics
FDA has accepted for review an Amgen and UCB BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at increased risk of fracture. The companies say romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby
Biologics
CDRH Division of Biostatistics deputy director Gerry Gray defined adaptive trial designs in a 9/22 webinar as “clinical studies that include some prospectively planned opportunity or set of opportunities to change the study design based on data accumulated during the course of the study without undermining the integrity and