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Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.
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After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
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Ovid Therapeutics Expands Its Scientific Leadership Team & Appoints Chief Strategy Officer
6/28/2023
Ovid Therapeutics Inc. today announced leadership appointments intended to enhance the execution of its corporate strategy and the scientific stewardship of its therapeutic development programs.
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A year after treatment, Vertex’s VX-880 has eliminated the need for insulin injections in two Type 1 diabetes patients in a Phase I/II clinical trial of its investigational stem cell-based therapy.
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Vertex and Lonza to Build Dedicated Manufacturing Facility for Type 1 Diabetes (T1D) Cell Therapies
6/26/2023
Vertex Pharmaceuticals Incorporated and Lonza announced a strategic collaboration to support the manufacture of Vertex’s portfolio of investigational stem cell-derived, fully differentiated insulin-producing islet cell therapies for people with T1D, currently focusing on the VX-880 and VX-264 programs that are currently in clinical trials.
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JDRF Joins Diabetes Professionals at the American Diabetes Association 83rd Scientific Sessions to Celebrate Advancements in Type 1 Diabetes Research
6/26/2023
JDRF joined thousands within the diabetes community at the American Diabetes Association's 83rd Scientific Sessions, where hundreds of experts presented significant advancements in diabetes research that may prove to be pivotal in improving lives and finding cures for T1D.
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Vertex Presents Positive VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the American Diabetes Association 83rd Scientific Sessions
6/23/2023
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today presented data on all patients dosed in Parts A and B of its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs).
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Eli Lilly has secured the rights to Verve Therapeutics’ gene editing approach, a “one-and-done” method that the companies hope will lower the cardiovascular risk factor lipoprotein(a).
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Spero Therapeutics Appoints Sath Shukla as President & Chief Executive Officer
6/14/2023
Spero Therapeutics, Inc. announced that Satyavrat “Sath” Shukla, Spero’s current Chief Financial Officer and Treasurer, will serve as Spero’s President and Chief Executive Officer, and as a member of the Board of Directors, effective August 1, 2023.
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Alkermes Issues Letter to Shareholders Highlighting Skills and Experience of Refreshed Board of Directors
6/13/2023
Alkermes plc issued a letter to its shareholders in connection with the Company's upcoming 2023 Annual General Meeting of Shareholders, which is scheduled to be held on June 29, 2023.
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CRISPR Therapeutics to Participate in Goldman Sachs 44th Annual Global Healthcare Conference
6/13/2023
CRISPR Therapeutics announced that members of its senior management team are scheduled to participate in a fireside chat at the 44th Annual Goldman Sachs Global Healthcare Conference being held from June 12th- 15th, 2023.
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The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
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Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
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Positive Results From Pivotal Trials of exa-cel for Transfusion-Dependent Beta Thalassemia and Severe Sickle Cell Disease Presented at the 2023 Annual European Hematology Association (EHA) Congress
6/9/2023
Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that both pivotal trials for exagamglogene autotemcel in patients with transfusion-dependent beta thalassemia or severe sickle cell disease met primary and key secondary endpoints at pre-specified interim analyses.
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Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment With CFTR Modulators at the European Cystic Fibrosis Conference
6/9/2023
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria.
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FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
6/8/2023
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
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AAVantgarde Closes €61 Million Series A Financing to Advance Two Therapeutic Programs into the Clinic
6/6/2023
AAVantgarde Bio, a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral vector platforms for large gene delivery, announced the closing of a €61 million Series A financing.
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Drugs that act on the CFTR protein only work in patients who produce the protein in the first place. That leaves 6% of patients hanging.
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ANGLE Announces Senior Management Appointments
6/5/2023
ANGLE plc, a world-leading liquid biopsy company, is delighted to announce the appointments of Brett Swansiger as Chief Commercial Officer and Karen Miller PhD as Chief Scientific Officer.
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Alkeus Announces $150 Million Series B Financing, Supporting Rapid Registration Path for gildeuretinol (ALK-001) in the Treatment of Stargardt DiseaseVertex Founder and Industry Pioneer Joshua Boger, Ph.D. named as Executive Chairman of Alkeus
6/5/2023
Alkeus Pharmaceuticals announced that it has raised a $150 million Series B financing to support the registration and launch of gildeuretinol, a potential disease-modifying, precision medicine for the treatment of Stargardt disease, a leading genetic cause of blindness in children and young adults.