Lundbeck

Lundbeck, IBM Watson Health collaborate on neurological disorders

Monday, January 30, 2017

Lundbeck is collaborating with IBM‘s Watson Health to accelerate the development of innovative medicines to treat psychiatric and neurological disorders. The collaboration will combine Lundbeck’s expertise in the treatment of psychiatric and neurological disorders with IBM’s cognitive and knowledge-based analytics to foster the discovery and development of new innovative treatments of disorders such as schizophrenia and Parkinson’s disease.

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FDA approves Carnexiv (carbamazepine) injection for seizures

Wednesday, October 12, 2016

Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

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NIH award expands landmark Alzheimer’s biomarker study

Tuesday, September 13, 2016

The Alzheimer’s Disease Neuroimaging Initiative (ADNI)—the long-running NIH-supported study investigating brain and fluid biomarkers of the disease—enters a new phase of discovery with the launch of ADNI3. With the recent NIH award of approximately $40 million over the next five years—coupled with anticipated private sector contributions of $20 million through the Foundation for the National Institutes of Health (FNIH)—ADNI3 will use cutting-edge technologies in brain imaging as it recruits hundreds of new volunteers. Expansion of the groundbreaking study, now in its 12th year, will further develop ways to speed clinical trials by providing researchers the biomarkers needed to detect the onset and track the progression of Alzheimer’s disease.

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FDA accepts Lundbeck resubmission of NDA for Carnexiv (carbamazepine)

Monday, April 25, 2016

The FDA has accepted for review the resubmission of Lundbeck’s New Drug Application (NDA) for intravenous Carnexiv, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2016. Lundbeck’s resubmission was in reply to the Complete Response Letter from the FDA issued in 2014 requesting additional data associated with the Chemistry, Manufacturing and Controls (CMC) of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.

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Cydan Development forms Imara for sickle cell disease

Friday, April 15, 2016

Cydan Development, an orphan drug accelerator dedicated to creating therapies that improves the lives of people living with rare genetic diseases, has launched Imara. This is the second orphan drug company launched by Cydan since 2015. Imara will develop IMR-687, a disease-modifying therapeutic selected specifically for the treatment of sickle cell disease and other hemoglobinopathies. IMR-687 was discovered by H. Lundbeck.

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Lundbeck joins Global Alzheimer’s Platform

Monday, August 10, 2015

Lundbeck, a global pharmaceutical company specializing in brain disorders, has joined the Global Alzheimer’s Platform (GAP) to help accelerate the development of new treatments for Alzheimer’s disease. GAP is a research initiative that aims to reduce the time and costs of Alzheimer’s disease clinical trials, develop an infrastructure that promotes innovation, and assure international collaboration on Alzheimer’s disease treatments.

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