Biologics
Sangamo Therapeutics says it reached agreement with FDA on a “clear regulatory pathway to accelerated approval for the company’s gene therapy candidate ST-920 (isaralgagene civaparvovec) for treating Fabry disease. The FDA has agreed in a Type B interaction that data from the ongoing Phase 1/2 STAAR study
Biologics
FDA has approved an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2
Biologics
FDA has published a guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or
Biologics
FDA has placed a clinical hold on Novavax’ IND for its Covid-19-influenza combination and standalone influenza vaccine candidates. A company statement says the hold is due to a spontaneous report of a serious adverse event of motor neuropathy in a single Covid/influenza combination Phase 2 trial participant
Biologics
GSK says it will submit a BLA based on recent positive data from its two Phase 3 trials (ANCHOR 1 and 2) evaluating depemokimab in chronic rhinosinusitis with nasal polyps. Both trials met their co-primary endpoints of a change from baseline in total endoscopic nasal polyp score at 52
Biologics
GSK says the latest trial data on its Arexvy respiratory syncytial virus (RSV) vaccine indicate protection through three RSV seasons. A company statement says Arexvy is the only RSV vaccine with efficacy and safety data available through three full seasons, including in people at increased risk. The company says Arexvy
Biologics
The Justice Department says that John Kosolcharoen, most recently of Orange County, CA, founder and CEO of Liveyon and Genetech, two companies that manufactured and distributed injectable stem cell products made from human umbilical cord blood, has been sentenced to 36 months in prison following his conviction on charges related
Biologics
FDA has published a guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, with help for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, new animal drugs,
Biologics
FDA has approved Fresenius Kabi and Formycon’s biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnson’s referenced Stelara, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The biosimilar was approved for both subcutaneous and intravenous formulations. Ustekinumab is described
Biologics
Johnson & Johnson has submitted a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication — combination use with bortezomib, lenalidomide and dexamethasone (D-VRd) for treating adults with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or not appropriate. The filing is
Biologics
The U.S. 9th Circuit Court of Appeals in San Francisco has reversed an 8/2022 California lower court decision (see earlier story) that ruled a stem cell treatment firm was exempt from FDA regulations. The lower court had declined to block California Stem Cell Treatment Center from continuing to
Biologics
FDA has approved a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. Approval was based on data from the IMROZ (NCT03319667) Phase 3 trial in 446 patients
Biologics
FDA has approved a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution
Biologics
The Institute for Clinical and Economic Review (ICER), a private, independent, nonprofit research institute, says that while it applauds FDA’s continued effort to create policies and guidance to enhance greater diversity in clinical trials, it is concerned about the stated intended goal of a draft guidance on diversity action
Biologics
FDA has approved AstraZeneca’s Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can result in damage to multiple organs. The approval was based on data from the noninferiority MANDARA Phase 3 trial published in The New England Journal of
Biologics
FDA has published a guidance, Conducting Clinical Trials with Decentralized Elements, with recommendations for sponsors, investigators, and other interested parties about implementing decentralized elements in clinical trials. The document says decentralized elements can include telehealth, visits with trial personnel, in-home visits with remote trial personnel, or visits with local
Biologics
FDA has approved Johnson & Johnson’s Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). Approval was based on data from the ongoing Phase 2b/3 QUASAR study evaluating Tremfya in adult patients with moderately to severely active UC who experienced an inadequate response or
Biologics
Gilead Sciences says data from an interim analysis from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, showed that it reduced HIV infections by 96% compared to background HIV incidence. “There were two incident cases among 2,180 participants, corresponding to
Biologics
GSK says it is moving its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data that demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults. “Interim data suggest the vaccine candidates have an acceptable safety
Biologics
GSK is not advancing the development of its investigational herpes simplex virus (HSV) vaccine candidate, GSK3943104, based on a data analysis of a recent Phase 1-2 study. “Results show that GSK3943104 did not meet the study’s primary efficacy objective,” the company says, adding that it will not progress
Biologics
CBER has released an updated standard operating policy and procedure (SOPP) manual entitled “SOPP 8404: Refusal to File (RTF) Procedures” that has updated RTF examples and an updated Appendix A that lists examples of easily correctible deficiencies. According to the document, RTF decisions may be made based on findings such
Biologics
FDA has posted a Form FDA-483 issued to Biocon Biologics at the end of a July inspection of the firm’s Bengaluru, India manufacturing facility. The document cites 10 observations: 1. Procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic process.