Biologics
FDA has accepted for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis (LN). The agency has set a user fee review action target date of 10/2025. The submission is based on data from the Phase 3 REGENCY trial. “The study demonstrated a statistically significant and clinically
Biologics
FDA has approved a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgen’s Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgen’s Xgeva. The approval covers all indications of the reference products. Approval is based on “robust clinical evidence,” including data from Phase 3 clinical trials in
Biologics
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should make sure its recent draft guidance entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” aligns with other relevant guidances developed by the Internation Conference on Harmonization. Specifically, PhRMA says the protocol deviations guidance should align with
Biologics
FDA has approved an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhinitis, with or without conjunctivitis, to now include children ages five through 11 years. Previously, the product was approved for use in patients aged 12
Biologics
In a move suggestive of HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s interference in FDA regulatory activities involving vaccines, the agency 2/26 abruptly canceled a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that would otherwise select the strains and the composition
Biologics
FDA has released the form FDA-483 issued following an 11/11-11/19/2024 inspection at the firm’s vaccine manufacturing facility in Incheon, South Korea. The form’s specific inspection observations were: * failure to have in writing and/or follow responsibilities and procedures for quality units to ensure
Biologics
Two stakeholders have submitted specific, line-by-line, technical comments on an FDA draft guidance on protocol deviations for clinical investigations of drugs, biological products, and devices. The comments were submitted by Labcorp and AstraZeneca.
Biologics
FDA has accepted for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP). PRGN-2012 is designed to “elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11,” the company says.
Biologics
A 6/7-6/12/2024 FDA inspection at Sperm Bank, Inc., doing business as Fertility Center of California in San Diego, CA, documented significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A 2/14 Warning Letter says specific deviations of concern were: * failure
Biologics
FDA has declined to approve an Invivyd request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of Covid-19 EUA for Pemgarda (pemivibart). The request sought authorization to provide a treatment option for mild-to-moderate Covid-19 in adults and adolescents who are immune compromised
Biologics
In a Hyman, Phelps & McNamara FDA Law Blog post, principal regulatory device and biologics expert Richard Lewis, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The post
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
Biologics
FDA has approved a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis which commonly cause invasive meningococcal disease (IMD), according to the company. “The vaccine combines the
Biologics
Shortly after Robert F. Kennedy, Jr., was confirmed as HHS secretary, Citizens MAHA (Mobilizing Advocacy to Heal America) filed a petition asking HHS and FDA to “suspend and revoke emergency use authorization and biologics licensure for mRNA Covid-19 vaccines and to conduct a comprehensive safety review due to unprecedented
Biologics
FDA has placed a clinical hold on a Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus (mRNA-1403) after a case of Guillain-Barré syndrome was reported. It is a two-season vaccine and the Northern Hemisphere portion of the study is
Biologics
FDA has approved Sanofi-Aventis’ Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisk’s Novolog (insulin aspart) for improving glycemic control in adults and pediatric patients with diabetes mellitus. An FDA release says Merilog is the first rapid-acting insulin biosimilar product approved by the agency. It is
Biologics
Sanofi and Johnson & Johnson have discontinued the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it was not sufficiently effective at preventing invasive E. coli disease (IED) compared to placebo. The decision was based on a review by an independent data
Biologics
FDA has granted Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. ADI-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for treating autoimmune
Biologics
A 9/11-9/15/2023 FDA inspection at BioStem Life Sciences in Pompano Beach, FL, determined that the company manufactures cellular products derived from human umbilical cord and an amniotic membrane combined with amniotic fluid product. A 1/17 Warning Letter says that while such products are legally considered
Biologics
FDA has approved a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. Susvimo is the first FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-
Biologics
FDA has posted a final guidance entitled “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The document updates recommendations for making a donor eligibility determination when screening a donor for clinical evidence of
Biologics
Four researchers and scholars who are founding members of the Council for Quality Health Communication say it’s time to unpack what is meant by vaccine safety and effectiveness and acknowledge individual concerns being raised by consumers. Writing in a MedPageToday Perspective column, the four say that many people don’