Japanese Scientists Reversed Signs of Alzheimer’s by Restoring Synapse Function in Mouse Model
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Japanese Scientists Reversed Signs of Alzheimer’s by Restoring Synapse Function in Mouse Model

A team of scientists from Japan appear to have pioneered a method for reversing synapse damage in an Alzheimer's disease mouse model. Although encouraging, the theory must be tested in…

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FDA’s Panel of Experts Vote 11-0 in Favor of Donanemab to Treat Alzheimer’s Disease
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FDA’s Panel of Experts Vote 11-0 in Favor of Donanemab to Treat Alzheimer’s Disease

The idiom ‘third time’s a charm’ may have some significance in this instance. The panel that advises the FDA just voted unanimously in favor of Eli Lilly’s experimental drug, donanemab.…

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Farxiga® has been FDA Approved to Treat Children and Adolescents in the U.S. for Type 2 Diabetes
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Farxiga® has been FDA Approved to Treat Children and Adolescents in the U.S. for Type 2 Diabetes

Ruud Dobber, executive VP of biopharmaceuticals at AstraZeneca was quoted in a press release dated saying that type 2 diabetes is on the rise in adolescents and younger children with…

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Pfizer Acknowledges the Death of a Young Boy Who Died One Year After Participating in its Phase II Clinical Trial to Treat DMD
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Pfizer Acknowledges the Death of a Young Boy Who Died One Year After Participating in its Phase II Clinical Trial to Treat DMD

Pfizer has recently paused its Phase III clinical trial that has been assessing the Duchenne muscular dystrophy candidate fordadistrogene movaparvovec. The Phase II DAYLIGHT trial (NCT05429372), enrolled ten boys ages…

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FDA Approves Dosage Boost for Lambert-Eaton Myasthenic Syndrome Drug FIRDAPSE
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FDA Approves Dosage Boost for Lambert-Eaton Myasthenic Syndrome Drug FIRDAPSE

According to a story from Globe Newswire, the biopharmaceutical company Catalyst Pharmaceuticals has recently announced an update to the company's supplemental New Drug Application (sNDA) for its drug amifampridine (marketed…

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Tardive Dyskinesia: Phase 3 Study Results Indicate Improvement with Use of INGREZZA®
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Tardive Dyskinesia: Phase 3 Study Results Indicate Improvement with Use of INGREZZA®

This week Neurocrine Biosciences announced the results of its KINECT®-4 Phase 3 study of INGREZZA® capsules. Results of the trial were published in the Journal of Clinical Psychopharmacology. A long-term…

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Cartesian Therapeutics Earns Regenerative Medicine Advanced Therapy Designation for Myasthenia Gravis
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Cartesian Therapeutics Earns Regenerative Medicine Advanced Therapy Designation for Myasthenia Gravis

Cartesian Therapeutics, Inc., a biotechnology company, recently announced that the FDA has awarded the Regenerative Medicine Advanced Therapy (RMAT) designation to its lead product, Descartes-08, to treat myasthenia gravis (MG).…

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Enrollment Completed in Clinical Trials for Primary Sjögren’s Syndrome and IgA Nephropathy
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Enrollment Completed in Clinical Trials for Primary Sjögren’s Syndrome and IgA Nephropathy

Jianmin Fang, M.D. the CEO of the biotechnology company RemeGen, recently announced in PRNewswire that the company is continuing its significant progress in its research of Telitacicept (RC18) to treat…

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First Patient Enrolled in VE303 Study for Recurrent C. Diff
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First Patient Enrolled in VE303 Study for Recurrent C. Diff

An estimated 25% of people with Clostridioides difficile (C. diff) infections experience recurrence following successful antibiotic intervention. After three or more recurrent infections, the risk of developing another infection sits…

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Congressional Briefing Highlights Impact of Research Funding on Rare Eye Diseases: Retinitis Pigmentosa and Stargardt Disease
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Congressional Briefing Highlights Impact of Research Funding on Rare Eye Diseases: Retinitis Pigmentosa and Stargardt Disease

Written by Judith Hill, Communications and Events Director, National Alliance for Eye and Vision Research In a remarkable show of unity and commitment to eye health, the Alliance for Eye…

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UC Davis Health Researchers Identify Biomarkers for Schizophrenia in 22q11.2 Deletion Syndrome

A 2008 report published in Current Psychiatry Reports found that approximately 1% of people with schizophrenia also have a rare genetic disorder called 22q11.2 deletion syndrome. This suggests that schizophrenia…

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Investigational New Drug (IND) Application Accepted for EB-105 to Treat Diabetic Macular Edema
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Investigational New Drug (IND) Application Accepted for EB-105 to Treat Diabetic Macular Edema

An Investigational New Drug (IND) application is a crucial part of the drug development process. INDs are requests submitted to the U.S. Food and Drug Administration (FDA) that authorize the…

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Could This Treatment for Ulcerative Colitis and Crohn’s Disease Get Approved in Europe?
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Could This Treatment for Ulcerative Colitis and Crohn’s Disease Get Approved in Europe?

According to reporting from News-Medical.net, Janssen-Cilag International NV recently announced that it had applied for European Medicines Agency (EMA) approval of its drug guselkumab (marketed as TREMFYA) in an expansion…

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New FDA Regulation on Laboratory Developed Tests Draws Objections from Healthcare Groups
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New FDA Regulation on Laboratory Developed Tests Draws Objections from Healthcare Groups

As reported in Biopharma Dive, the FDA’s decision to strengthen its authority involving laboratory developed tests (LDTs) has drawn considerable objections from various healthcare groups. However, the Agency has held…

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FDA Rejects Epidermolysis Bullosa Cell Therapy and Requests Additional Manufacturing Data
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FDA Rejects Epidermolysis Bullosa Cell Therapy and Requests Additional Manufacturing Data

Clinical-stage biotechnology company Abeona Therapeutics ("Abeona") is working to develop a novel cell therapy for people living with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder characterized by…

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