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FarmaKology-Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma
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vTv Therapeutics Inc.
vTv Therapeutics is a clinical stage biotech company committed to improving the lives of diabetes patients.vTv has a pipeline of clinical drug candidates developed using our innovative technology and led by our TTP399 program for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, psoriasis, atopic dermatitis, renal disease, primary mitochondrial myopathy, and pancreatic cancer.
Nebraska Medicine & Helix Partner to Provide Precision Care in Nebraska to Help Find Health Issues Individually and Statewide
Helix, the leading population genomics and viral surveillance company in the nation, and Nebraska Medicine, the state’s largest hospital and leading academic health network, announced a partnership today to launch a population genomics program to drive precision medicine for all individuals in Nebraska called the Genetic Insights Project. The research program will identify participants’ risk for a variety of cancers and other potentially life-threatening diseases with a single test, with the goal of not only helping to improve the lives of individual patients but also identifying trends for everyone across the region.
Gilead and Tentarix to Discover and Develop Novel Therapies to Address Unmet Medical Needs Across Cancer and Inflammation
Gilead Sciences, Inc. and Tentarix Biotherapeutics today announced that the companies established three multi-year collaborations leveraging Tentarix’s proprietary Tentacles™ platform to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases. Designed to enhance both therapeutic benefit and safety, these molecules have the potential to conditionally target immune cells related to disease pathways without activating other immune cells that may create adverse events.
Sandoz, a global leader in off-patent medicines, today releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need. Mylight (ClinicalTrials.gov NCT04864834) is part of a comprehensive biosimilar development program that encompasses analytical, preclinical, and a clinical study. The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. Safety, immunogenicity, and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products.
Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma
Pfizer Inc. announced the U.S. Food and Drug Administration has granted accelerated approval to ELREXFIO™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).