Type 1 Diabetes
Mar 18, 2025
FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials
MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...
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Jan 14, 2025
Agios’ PYRUKYND SNDA Accepted by FDA for Thalassemia; BridgeBio’s BBO-8520 Gets FDA Fast Track for KRASG12C-Mutated Lung Cancer; Nipocalimab Granted FDA Priority Review for Myasthenia Gravis; Rigel’s R289 Receives FDA Orphan Drug Designation for MDS; Rise Therapeutics Gets FDA IND Clearance for R-5780 in Cancer
FDA Accepts Agios’ SNDA for PYRUKYND in Thalassemia Patients Agios Pharmaceuticals, Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) to treat adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The appl...
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Mar 05, 2024
Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...
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Jul 04, 2023
First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug
FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...
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May 01, 2023
Cell and Gene Therapies for Diabetes Treatment: A Permanent Cure for Patients?
Diabetes is the 8th largest cause of death in the United States (although its prevalence may be underreported). Diabetes affects more than 37 million people in the United States, and 1 in every 5 are unaware of their condition. Over 96 million US adults—more than one-third—have prediabetes, and more than 8 out of 1...
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Jul 19, 2022
Byondis’s HER2-targeting ADC trastuzumab duocarmazine; AbbVie Migraine Drug Atogepant; Grünenthal Acquires Bayer’s Testosterone Drug Rights; Vertex Acquires ViaCyte; Merck & Orion Announces Collaboration; Verve Starts Trials of Cholesterol Drug; Kyowa Kirin Drops Nourianz follow-up KW-6356; FDA Orphan Drug and Fast Track Designations to CV-01
Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and Ast...
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Jun 09, 2022
REVIAN RED System Delivers Positive Results, Insulet’s Omnipod Provides Notable Improvement in Type 1 Diabetes, FDA Clearance to Cardio Flow’s FreedomFlow Guidewire; LumiraDx’s Cardiovascular Testing Portfolio; GRAIL-AstraZeneca to Develop Diagnostic Tests; ETHICON Launches Next Generation ECHELON 3000 Stapler
Positive Results Report REVIAN RED System as a Possible Treatment for Central Centrifugal Cicatricical Alopeciain African American Women On June 02, 2022, REVIAN Inc., an aesthetic medical technology company focused on stimulating the body's natural processes in order to rejuvenate hair and skin with light relea...
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Apr 02, 2020
Niacin fights Glioblastoma, iTeos nets $125M, Pandion reels in $80M, Brii, Chinese partner, FDA to speed up COVID-19 therapies
Niacin might help in combating Glioblastoma Glioblastomas are difficult to treat in part as the brain’s immune cells are stifled and unable to attack against tumors. A research team of the University of Calgary in Canada revealed that a common vitamin might help resolve the issue. The researchers presen...
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Nov 28, 2019
Toujeo to treat Type 1 Diabetes; TauRx for Alzheimer’s patients
Sanofi’s Toujeo has received FDA recommendation for its expanded use in Type 1 Diabetes. Toujeo is an insulin glargine injection to control the highs and lows of blood sugar in the body. Indicated to be used in adults and paediatric patients of age six and older. Earlier, the injection was considered suitab...
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Jun 12, 2019
Teplizumab delays the progression of Type 1 Diabetes
The study published in The New England Journal of Medicine set out to study the effect of the drug teplizumab in people at high risk for type 1 diabetes. According to recent Phase II clinical trials, in experimental immunotherapy conducted, the drug has been able to delay the onset of disease for the first tim...
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