Seizures Archives - PharmaLive

SK life science Presents Long-term Data on Cognitive and Psychiatric Adverse Events Associated with XCOPRI CV in Adults with Partial-Onset (Focal) Seizures at the AAN 2022 Annual Meeting

American Academy of Neurology (AAN) Annual Meeting, Central Nervous System Diseases, Clinical Studies, Clinical Trials, Epilepsy, Oncology, Partial-Onset Seizures, R&D

SK Life Science Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd. – an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders – will present data from a pooled analysis from studies C013/C017 OLEs and C021 evaluating the cognitive and psychiatric treatment-related adverse events during adjunctive treatment with anti-seizure medication XCOPRI® (cenobamate tablets) CV at the American Academy of Neurology Annual Meeting, held in-person in Seattle April 2–7, 2022.

March 31, 2022/by PR Newswire

FDA Greenlights UCB Drug for Severe Form of Epilepsy

Approvals, Children, Clinical Trials, Epilepsy, Expanded Approval, Expanded Indication, FDA, Lennox-Gastaut Syndrome (LGS), Pediatric exclusivity, R&D, Seizures, Therapeutics, UCB

UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.

March 28, 2022/by BioSpace

U.S. FDA approves Marinus Pharma’s drug to treat seizures; shares jump

Business, CDKL5 deficiency disorder (CDD), Drug Enforcement Administration (DEA), Drug Pricing, FDA, Rare Genetic Diseases, Seizures, Shares, Therapeutics

The U.S. health regulator approved Marinus Pharmaceuticals Inc.’s lead drug to treat seizures associated with a rare genetic disorder in patients two years of age and older, the company said on March 18, sending its shares soaring around 36 percent.

March 18, 2022/by Reuters Health

Research Consortium to Study If Covid-19 Increases Long-Term Risk of Dementia

Brain, Brain Function, CNS SARS-CoV-2 Consortium, Coronavirus Disease 2019 (COVID-19), Dementia, Neurological symptoms, Neurologists, New England Journal of Medicine, Papers, Psychosis, SARS-CoV-2 virus, Seizures, Studies

In a paper published in Alzheimer’s and Dementia, a team of researchers called for more prospective studies that will look into the impact COVID-19 has on brain functioning, given the disease has been frequently associated with neurologic symptoms such as seizures and psychosis.

January 6, 2021/by BioSpace

FDA Awards Fast Track Designation to Multiple Non-Covid-19 Candidates

Acid Disorders, Acute repetitive seizures, Coronavirus Disease (COVID-19) Pandemic, Fast Track Designation, FDA, Gene Therapy, Hypogammaglobulinemia, Imaging Agents, Infections and Myelokathexis) syndrome, Methylmalonic Acidemia (MMA), MPS Type VI, Non-Small Cell Lung Cancer (NSCLC), Phenylketonuria (PKU), Primary Mitochondrial Myopathy (PMM), Solid Tumors, WHIM (Warts

While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.

November 4, 2020/by Andrew Humphreys

FDA Action Alert: Aquestive, Eton and Mesoblast

Adrenal Glands, Adrenal Insufficiency, Business, Clinical Trials, Congenital Adrenal Hyperplasia (CAH), Epilepsy, FDA/Regulatory, Glands, New Drug Application (NDA), Oncologic Drugs Advisory Committee (ODAC), PDUFA, Pediatric, Quarterly results, R&D, Seizure Clusters

The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.

September 28, 2020/by Andrew Humphreys

FDA Approves Fintepla for Seizures Associated with Dravet Syndrome

Approvals, Dravet syndrome, FDA, FDA/Regulatory, Seizures

The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

June 25, 2020/by GlobeNewswire

FDA Action Alert

Acromegaly, Blockbusters, Checkpoint Inhibitors, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Diffuse Large B-Cell Lymphoma (DLBCL), Dravet syndrome, FDA/Regulatory, NDA Resubmission, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Postoperative Pain, R&D, Seizures, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics

Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.

June 22, 2020/by BioSpace

Neurelis Announces Commercial Availability of Valtoco for Seizure Cluster Rescue

Adults, Approvals, Business, FDA, Nasal Sprays, Pediatric, Product Launches, Seizure Clusters, Therapeutics

Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.

March 2, 2020/by PR Newswire

FDA Accepts NDA for Aquestive’s Libervant for Seizures

Anti-Epileptic Drugs (AEDs), Buccal Film, Epilepsy, FDA, FDA/Regulatory, New Drug Application Acceptance, Seizure Clusters

The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.

February 10, 2020/by BioSpace