STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.
STOCKHOLM, Jan. 8, 2024 /PRNewswire/ -- Market research including initial interviews with US health care practitioners as well as US payers demonstrated a strong willingness to consider prescribing the investigational precision medicine Diamyd® for Type 1 Diabetes and pricing in the range of USD 200,000. Diamyd® is currently being evaluated in the registrational Phase 3 trial DIAGNODE-3 in patients recently diagnosed with Type 1 Diabetes that carry the HLA DR3-DQ2 haplotype.
Diamyd partners with DiaUnion to recruit participants for diabetes trial
STOCKHOLM, Oct. 17, 2023 /PRNewswire/ -- Diamyd Medical is hosting a webcast presentation on October 20th at 2:00 pm CET / 8:00 am EDT with Ulf Hannelius, CEO of Diamyd Medical, Josh Vieth, Director of Research at JDRF, as well as Mark Atkinson, Director for the University of Florida Diabetes Institute and member of the Board of Directors of Diamyd Medical.
STOCKHOLM, March 10, 2023 /PRNewswire/ -- Diamyd Medical today announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders. Dr. Rosén has deep experience from the biotechnology industry with more than two decades of working in senior leadership positions in global clinical development and U.S. and global medical affairs across her time with Horizon Therapeutics, GSK (GlaxoSmithKline), Aimmune Therapeutics and Genentech, a member of the Roche group.
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the Phase III DIAGNODE-3 trial of Diamyd Medical ’s antigen-specific immunotherapy Diamyd.
STOCKHOLM, Nov. 28, 2022 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd® in individuals recently diagnosed with type 1 diabetes. Following the decision from the FDA, DIAGNODE-3 is approved to start in the US.
The primary endpoints of safety and tolerability were met in the open-label investigator-initiated Phase II clinical trial GADinLADA, in which the...
Diamyd Medical announces today that The Swedish Medical Products Agency has given approval for the start of DIAGNODE-3, a placebo-controlled precision medicine Phase III trial with the diabetes vaccine Diamyd®. The trial is designed to confirm the efficacy and safety of Diamyd® in individuals recently diagnosed with type 1 diabetes, who carry the genetically defined haplotype HLA DR3-DQ2.