Biologics
A 10/2-10/10 FDA for-cause good clinical practice (GCP) inspection of Care Access’ activities in the Pfizer VALOR trial of an investigational Lyme disease vaccine resulted in no inspection observations and no issuance of a form FDA-483, according to a company statement. The inspection came after
Biologics
Coherus BioSciences has resubmitted a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta that is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. Last month, FDA issued
Biologics
The Reagan-Udall Foundation has published Strategies for Improving Public Understanding of FDA-Regulated Products, providing observations, potential strategies, and illustrative tactics for FDA to consider. A foundation announcement (contains links to the report and a virtual public meeting discussing the findings) says the strategies result from the foundation’s
Biologics
Moderna says it will start a Phase 3 trial of its investigational mRNA-1083 combination vaccine against flu and Covid-19 later this year. The company says the decision to open a Phase 3 trial follows interim reports of positive data from a Phase 1/2 trial. Moderna says it
Biologics
A 12/1/21-12/16/21 FDA inspection at Signature Biologics in Irving, TX, documented that the firm manufactures Signature Cord, a product derived from human umbilical cord for allogeneic use. A just-released 9/18 Warning Letter says the firm has distributed the product directly to healthcare professionals
Biologics
FDA has amended the emergency use authorization of Novavax’s Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and older to include the 2023-2024 formula. The updated vaccine is intended to provide protection against currently circulating variants to provide better protection against serious sickness, including
Biologics
FDA has approved a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody referencing Genentech’s arthritis drug Actemra. Tofidence is approved for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. FDA approval of Tofidence was based on
Biologics
FDA’s Cellular, Tissue, and Gene Therapy Advisory Committee 9/27 voted 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenchymal stem cell therapy for treating amyotrophic lateral sclerosis (ALS, and also known as Lou Gehrig’s Disease). Panel members mostly agreed with FDA
Biologics
FDA has published a draft guidance, Graft-versus-Host Disease: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment, to assist sponsors in developing such products. Specifically, the document addresses the agency’s current thinking about the overall clinical development program and critical design elements for early- and
Biologics
A CBER review of the Web site maintained by the Peace Wellness Center in Phoenix, AZ, established that the company markets “stem cell therapy” products to consumers to treat various diseases or conditions. Implying potential violations, a 9/21 unlabeled letter says the company represents that the products are derived
Biologics
Attorney Maarika Kimbrell (Morgan Lewis) says CBER “is poised for change on a number of important fronts — leadership, significant growth, and plans to address challenging scientific and regulatory issues.” Writing in an online post, Kimbrell says that earlier this year CBER reorganized, establishing an Office of Therapeutic Products (OTP) as
Biologics
Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy (GAN) after receiving FDA feedback in a recent Type C meeting. The company says its decision is “due to challenges related to the feasibility of the study
Biologics
Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy that targets and eliminates EBV-infected cells in a human leucocyte antigen-restricted manner. The company says it recently achieved agreement with FDA on the company’
Biologics
[Report by Jim Dickinson] Data cited by FDA and CDC to support vaccinating everyone over age six months against the latest Covid-19 variants are “quite incredible … it’s almost as if the CDC were arithmetically challenged,” according to retired English doctor John L. Campbell in a scathing 15-minute
Biologics
FDA has issued a draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency says the document’s recommendations for biosimilar and interchangeable biosimilar product labeling pertain only to the prescribing information, except for certain recommendations in Section V (FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar
Biologics
FDA has extended by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The accelerated approval submission’s review
Biologics
FDA has published a guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989, to give information to applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products
Biologics
The International Society for Pharmaceutical Engineering (ISPE) says FDA should incorporate the concepts and terms in the International Council for Harmonization Q12 guidance on technical and regulatory considerations for pharmaceutical product lifecycle management in an FDA draft guidance on manufacturing changes and comparability for human cellular and gene therapy products.
Biologics
FDA has given the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely target currently circulating variants and to provide better protection against serious illness, including hospitalization and death. “Consistent with the totality of the evidence and input from the FDA’
Biologics
FDA says it is working closely with the Centers for Disease Control and Prevention to investigate reports of a tuberculosis (TB) outbreak caused by Mycobacterium tuberculosis that appears to be linked to a bone matrix product. An agency online post outlines risk mitigation strategies for human cell, tissue, and cellular
Biologics
Moderna says its updated Covid-19 vaccine, which is awaiting FDA approval, generated a strong immune response against the BA.2.86 (Pirola) variant that the Centers for Disease Control has said might be more likely to break through existing immunity from previous vaccinations because it has over 30 mutations.
Biologics
FDA has denied a 10/28/2020 petition submitted by the Informed Consent Action Network (ICAN) asking that the agency require all manufacturers of acellular pertussis-containing vaccines to amend their labeling and package inserts to state that the vaccines do not prevent infection and transmission of pertussis. “Your petition