Biologics
FDA has accepted for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, Alvotech’s proposed biosimilar to Janssen Biotech’s Simponi and Simponi Aria (golimumab), which are used to treat moderate to severe inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. An FDA action is
Biologics
FDA says its review of a Web site maintained by Evolutionary Biologics in New York, NY, and its inspection at Chara Biologics in Chatsworth, CA, determined that the firms are selling unlicensed biologic products that are legally considered to be unapproved new drugs. A just-released 12/30/2024 Warning
FDA Policy/General
Three Ropes & Gray attorneys write in their 2024 FDA Enforcement Review that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective
Biologics
CBER director Peter Marks’ annual report for 2024 says the Center approved 24 biological devices, 17 BLAs, and 26 BLA supplements in 2024. The report also says CBER continued its focus on facilitating the development of cell and gene therapies through numerous public town halls, Webinars, and a workshop, along
Biologics
FDA has accepted for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The agency has set a user fee review action target date of 7/22. The BLA is supported by data from the IGNYTE trial demonstrating that one-
Biologics
In what may be one of the last actions by FDA commissioner Robert Califf before he resigns his post ahead of the incoming Trump administration’s start date next Monday, the commissioner has posted a comprehensive essay and personal reflection on the safety and effectiveness of Covid-19 vaccines. Califf’
Biologics
FDA has published one draft foundation guidance and five immediately effective guidances covering specific disease agents and diseases to assist establishments that make eligibility determinations for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps) to understand the regulations governing donor eligibility. The draft foundation guidance,
Biologics
An FDA summary report on clinical study diversity action plans for FY 2023 and FY 2024 shows that submission of the action plans to the agency is going up, even though such submissions are not yet required. The report shows that CDER received 124 plans in FY 2023 and 161
Biologics
FDA has approved a guidance, Communications from Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers, to reassure firms that if they provide communications that are consistent with the guidance’s recommendations, the agency will not consider the dissemination of such
Biologics
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for increasing the number of females in clinical trials and non-interventional studies to help ensure the generalizability of results. The document says it also has recommendations for analyzing and interpreting
Biologics
An FDA alert says the agency has required safety labeling changes about Guillain-Barré syndrome risks for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline Biologicals’ Arexvy (respiratory syncytial virus vaccine, adjuvanted). Guillain-Barré syndrome is a rare disorder in which the body’s immune system damages nerve cells,
Biologics
Xbrane Biopharma has resubmitted a BLA for its investigational ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor therapy that prevents vision loss
Biologics
Four Ropes & Gray attorneys say the 9/27 9th Circuit Court of Appeals decision backing FDA regulation of stem cell treatment, which followed a 2021 similar ruling by the 11th Circuit, will make it harder for other clinics to argue that their procedures are exempt from agency oversight. Writing
Biologics
A Texas federal court 12/6 ruled against FDA in an ongoing Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in 2021 and the agency was ordered
Biologics
FDA has accepted for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for treating patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for
Biologics
The House Select Subcommittee on the Coronavirus Pandemic has issued its final 550-page report that generally praises actions taken under the Trump administration and criticizes actions taken by the Biden administration. A committee statement (including a link to the full document) says “After Action Review of the Covid-19
Biologics
Neurogene is reporting that a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died following complications from a rare and life-threatening hyperinflammatory syndrome associated with systemic exposure to high doses of adeno-associated virus (AAV), the company says. Neurogene says FDA
Biologics
FDA has granted Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Approval is based on data from the HERIZON-BTC-01 (NCT04466891) open-label, single-arm trial in 62 patients, according
Biologics
Sen. Ron Johnson (R-WI) has directed FDA, HHS, and CDC to “immediately preserve all records referring or relating to the development, safety, and efficacy of the Covid-19 vaccines.” In a statement (includes a link to the text of a letter to the agencies), Johnson says that under the
Biologics
FDA has posted a draft guidance entitled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” The document is intended to provide industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during cell/gene therapy development. The FAQs cover multiple disciplines, including regulatory review,
Biologics
FDA has accepted for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The user fee review action target date is 4/
Biologics
Adaptimmune Therapeutics says it plans to begin a rolling BLA next year for cell therapy lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy. The company’s decision to seek marketing approval is based on just-announced positive data from