Biologics
An FDA review of the Web site maintained by Mother Stem Institute in Coral Gables, FL, and records it submitted in response to an agency request, established that the firm recovers and processes adipose tissue from donors for autologous use as “stem cells.” An 8/20 Warning Letter says the
Biologics
A week after granting competitors Moderna and Pfizer marketing authorization for their updated monovalent Covid-19 mRNA vaccines, FDA has granted an emergency use authorization for an updated version of Novavax’s Covid-19 vaccine that more closely targets currently circulating variants to protect against serious Covid-19-related disease,
Biologics
FDA has approved an Emergent BioSolutions supplemental BLA for an expanded indication for ACAM2000, (smallpox and mpox vaccine, live) to include preventing mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available data showing that ACAM2000 is effective in protecting
Biologics
Johnson & Johnson has submitted a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis (MG). The submission is based on data from the Phase 3 Vivacity-MG3 study that “showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of
Biologics
Liveyon founder and CEO John Kosolcharoen pleaded guilty on 8/26 to a felony violation of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. A Department of Justice statement says he is currently in custody
Biologics
FDA has approved and given emergency use authorization for updated monovalent Covid-19 mRNA vaccines produced by Moderna and Pfizer. An agency statement says the updated 2024-2025 vaccines are formulated to correspond to the Omicron variant KP-2 strain of SARS-CoV-2. Updated Covid vaccines more closely target
FDA Policy/General
The FDA Bioresearch Monitoring (BIMO) FY 2023 metrics report shows there were 1,073 BIMO inspections across the five FDA Centers. CDER had by far the largest number of inspections at 779, with 141 through CDRH, 126 through CBER, and 26 through CVM. The report also gives common inspection observations
Biologics
FDA has approved a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. The
Biologics
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy. The company says a review action target date is expected during the fourth quarter of
Biologics
FDA has approved a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness or full-thickness thermal burns. Previously the product was approved for the same indication but for use in adults only. The expanded approval was based on results from the
Biologics
FDA has approved a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis. The underdiagnosed neuroimmune skin disease is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality, the company says. Galderma says
Biologics
A 3/15-5/19/2023 FDA Bioresearch Monitoring Program inspection of a clinical study led by Konrad Rejdak in Lublin, Poland, found objectionable conditions. A just-released 5/29 Warning Letter says the agency has determined that Rejdak violated regulations governing the proper conduct of clinical studies involving investigational
Biologics
FDA has told Humacyte it needs more time to complete the review of the company's BLA for the acellular tissue-engineered vessel (ATEV), indicated for treating vascular trauma. “During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and
Biologics
AdvaMed says it supports FDA’s long-standing bioresearch monitoring (BIMO) program and the provision of the FDA Omnibus Reform Act of 2022 that codified the program into law. In its comment on an FDA draft guidance on BIMO inspection processes and practices, AdvaMed says the agency should clarify that
Biologics
FDA has asked Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. “The FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a
Biologics
The American Society of Gene & Cell Therapy says it would like FDA to clarify aspects of its draft guidance on considerations for using human- and animal-derived materials in the manufacture of cellular and gene therapy and tissue-engineered medical products. Its comment letter asks for clarifications on these
Biologics
FDA has published a guidance, Recommendations for Investigational and Licensed Covid-19 Convalescent Plasma, with recommendations to blood establishments for submitting a BLA for the manufacture of Covid-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving either outpatient or inpatient immunosuppressive treatment. The document
Biologics
The Massachusetts Institute of Technology Center for Biomedical Innovation (CBI) is recommending that FDA use a draft guidance on safety testing of human allogeneic cells expanded for use in cell-based medical products to recommend a transition to the high-throughput sequencing (HTS) molecular-based technology. In its comment letter
Biologics
FDA has created a docket to receive information and comments on how best to advance the development of new biosimilar biological products as part of the agency’s commitments under the Biosimilar User Fee Amendments of 2022. The agency is asking for industry input on whether biosimilar product development would
Biologics
FDA has accepted a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema (DME) and diabetic retinopathy (DR), the two leading causes of vision loss in adults with diabetes. Susvimo is the first refillable eye implant that provides continuous delivery of ranibizumab through
Biologics
FDA is planning to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durvalumab) injection that is seeking its use in combination with platinum-containing chemotherapy as neoadjuvant treatment. The application proposes that this would then be followed
Biologics
FDA has approved a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexion’s Soliris (eculizumab), indicated for treating patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome. The approval was based on a “totality of evidence” including analytical, non-clinical and