Biologics
FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute in San Juan, Puerto Rico, and its medical director/owner to immediately cease manufacturing due to significant violations of FDA regulations. An agency statement says an inspection and record review revealed significant violations of regulations on donor eligibility determinations, including donor
Biologics
CBER Office of Compliance and Biologics Quality has issued RichSource Stem Cells an untitled letter over promotional statements on its Web site (https://richsourcestemcells.com) for cell therapy and “regenerative therapy” RichGen. The letter says that the product also does not have an approved BLA. “We note that your product
Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is 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;
Biologics
FDA has hit a milestone with the approval of Pfizer’s Abrilada (adalimumab - afzb), a biosimilar to AbbVie’s Humira, which is the 25th biosimilar product approved since 2010 when Congress gave the agency authority to approve biologic product knockoffs. Abrilada is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis,
Biologics
FDA has approved a Sanofi supplemental BLA for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. The vaccine was originally approved in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. The high-dose vaccine
Biologics
CBER has posted a document providing “Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).” Establishments that manufacture such products are required to register and list their products electronically with FDA for the manufacturing steps they perform using eHCTERS (21 CFR Part 1271). Establishments that manufacture
Biologics
FDA has accepted for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum disorder. The rare, debilitating autoimmune disease of the central nervous system primarily damages the optic nerves and spinal cord, which can cause blindness, muscle weakness and paralysis. Those with the disorder
Biologics
A Pew Trusts report, “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight,” says the agency’s 2017 guidance documents that constitute its regulatory framework “marks an important step in the agency’s efforts to encourage the development of new therapies while also protecting patients from dangerous unapproved interventions.
Biologics
FDA has given the green light to BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010. The study is being funded by NIHֺ’s National Institute of Allergy and Infectious Diseases. Product development is ongoing through BlueWillow’s partnership with Porton
Biologics
FDA has made available a final guidance entitled “Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review.” The technical specifications document provides detailed information and specifications for the content of datasets submitted to CBER. It is also intended to aid clinical and statistical reviewers in the
Biologics
FDA has approved an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) for treating atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) for adult and pediatric patients. The ultra-rare disease can cause progressive injury to vital organs, primarily the kidneys, by damaging walls of blood vessels.
Biologics
FDA says its scientists have developed two candidate vaccine viruses that may be used as the starting material for producing inactivated influenza vaccines. The candidate vaccine viruses protected lab animals against a highly pathogenic strain of Influenza A (H7N9), a potentially pandemic virus, an agency statement says. The candidates are
Biologics
FDA has accepted for review a DBV Technologies BLA for its investigational Viaskin peanut immunotherapy for treating peanut-allergic children ages four to 11 years. The once-daily, epicutaneous patch is designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts by delivering
Biologics
FDA has made available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus. The document provides recommendations and asserts that each donation found to be reactive must be further tested using a licensed, approved or cleared
Biologics
The White House has issued a Fact Sheet saying that President Donald Trump has signed an executive order “to modernize influenza vaccines and help protect more Americans through vaccination.” The sheet says the administration will work to promote new technologies to improve vaccine manufacturing and effectiveness, reducing reliance on more
Biologics
FDA has approved Bavarian Nordic A/S’s Jynneos smallpox and monkeypox vaccine, live, non-replicating, who are determined to be at high risk for smallpox or monkeypox infection. It is the only FDA-approved vaccine for preventing monkeypox disease. The agency says that Jynneos will be available for those
Biologics
FDA has accepted for priority review a Merck BLA for its investigational Ebola vaccine (V920) for preventing disease caused by the Ebola Zaire virus. The agency has set a 3/14/2020 user fee review action target dated. In July 2016, FDA granted Breakthrough Therapy Designation to V920. While developing
Biologics
FDA says agency scientists have developed a technique that enables them to determine whether immune system cells (dendritic cells) appear primed to trigger the production of antibodies against Factor VIII products used to treat hemophilia A. “The technique might enable scientists to use the presence of such primed dendritic cells
Biologics
Endo International has submitted a BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks. The submission is based on data from two identical Phase 3 RELEASE studies that demonstrated a greater percentage of the 843 women treated during the studies met the primary endpoint of response with
Biologics
A 3/4-3/8 FDA inspection at Stemell, Inc., San Juan Capistrano, CA, found current good manufacturing practice (CGMP) and current good tissue practice (CGTP) violations in the firm’s manufacturing of products derived from human umbilical cord blood and umbilical cord for allogenic use. An 8/28 Warning
Biologics
FDA has accepted for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients with neuromyelitis optica spectrum disorder. The rare autoimmune disease is characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis, according to the company. The
Biologics
The Pew Charitable Trusts says that while FDA and members of Congress have taken important steps in recent months to protect consumers from unproven and risky stem cell products offered by hundreds of clinics nationwide, “the agency needs to take broader action to deter businesses from selling interventions whose safety