SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.
Rockville, Maryland-based RegenxBio entered a license deal with Pfizer for a gene therapy for Friedreich’s ataxia, the most common hereditary ataxia.
VistaGen’s Antidepressant Fails in Difficult-to-Treat Patients Trial
Antidepressants, Clinical Trials, CNS, Fast Track Designation, FDA, Major Depressive Disorder (MDD), N-methyl-D-aspartate (NMDA) receptor, Nasal Sprays, National Institute of Health, Social Anxiety Disorder, Treatment-Resistant DepressionWhen major depressive disorder does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it’s reclassified as treatment-resistant depression (TRD). South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet the primary efficacy endpoints for TRD in a Phase II clinical trial.
PTC Therapeutics to Acquire Agilis Biotherapeutics
Acquisitions, Angelman Syndrome, Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency, Biologics License Application (BLA), Biotech, Business, CNS, Gene Therapy, Monogenic Diseases, Neurodegenerative Diseases, Neurological Disorders, Product PipelinesPTC Therapeutics Inc. announced an agreement to acquire Agilis Biotherapeutics Inc., a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
Breakthrough Therapy Status, Clinical Trials, CNS, EGFR tyrosine kinase inhibitors (TKI), FDA, Metastases, Mutations, New England Journal of Medicine, Non-Small Cell Lung Cancer (NSCLC), Priority Review Status, Supplemental New Drug Application (sNDA)AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
By David Beier, John Osborn and Merv Turner A familiar trope employed at the climax of movie thrillers is the zombie who returns from the dead to devour the brains […]
Data Presented at the International Congress of Parkinson’s Disease and Movement Disorders APL-130277, Sublingual Apomorphine, for On-Demand Treatment of OFF Episodes Associated with Parkinson’s Disease TORONTO, ONTARIO–(Marketwired – June 25, […]
