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SK Biopharmaceuticals' carisbamate granted orphan drug status for treating infantile spasms

Friday, April 20 2012 | Comments
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SK Biopharmaceuticals Co. Ltd.'s carisbamate, a chlorophenyl carbamate, received an orphan drug designation from the Food and Drug Administration for the management of infantile spasms, a form of epilepsy that is associated with increased risk for death or mental retardation. Carisbamate, one of the key products in the firm's central nervous system development pipeline, has demonstrated efficacy in clinical trials for adult forms of epilepsy, such as partial-onset seizures, according to...

SK Biopharmaceuticals Co. Ltd.'s carisbamate, a chlorophenyl carbamate, received an orphan drug designation from the Food and Drug Administration for the management of infantile spasms, a form of epilepsy that is associated with increased risk for death or mental retardation.

Carisbamate, one of the key products in the firm's central nervous system development pipeline, has demonstrated efficacy in clinical trials for adult forms of epilepsy, such as partial-onset seizures, according to SK Biopharmaceuticals. The company said the exact mechanism of action of the drug's therapeutic benefit has not yet been defined.

SK Biopharmaceuticals noted that the onset of infantile spasms generally occurs during the first year of life and they usually stop by the time the child reaches 5 years of age but may be replaced by other types of seizures. Infantile spasms are the major cause of cognitive deterioration in the first year of life, the firm added.

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Tuesday, March 06 2012 | Comments
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Eisai Co. Ltd. received notification from the Food and Drug Administration that the agency accepted for review the resubmitted New Drug Application (NDA) for perampanel, a highly selective, noncompetitive, AMPA-type glutamate receptor antagonist, for the treatment of partial-onset seizures associated with epilepsy.

Eisai originally submitted the perampanel NDA last May, but the FDA...

Tags: Epilepsy


Acorda agrees to buy Neuronex Verusmed

Friday, February 17 2012 | Comments
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Acorda Therapeutics Inc. entered into an agreement to acquire privately held Neuronex Inc.

Under the agreement, Acorda made an up-front payment of $2 million to Neuronex and paid $500,000 toward as much as $1.2 million in research funding to prepare for a pre-New Drug Application (NDA) meeting with the

Tags: Epilepsy


UCB's Keppra approved as adjunctive therapy for partial-onset seizures in infants, young children Verusmed

Wednesday, January 25 2012 | Comments
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UCB Inc.'s Keppra (levetiracetam) tablets and oral solution were approved by the Food and Drug Administration for the treatment of partial-onset seizures in infants and children aged 1 month or older with epilepsy, effectively expanding the drug's use for partial-onset seizures to include a younger patient population, according to the firm's parent company,

Tags: Epilepsy


UCB, Otsuka discontinue immunology collaboration, focus on development of CNS drugs in Japan Verusmed

Friday, January 13 2012 | Comments
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UCB SA and Otsuka Pharmaceutical Co. Ltd. discontinued their immunology collaboration and will instead focus on developing drugs for central nervous system disorders in the Japanese market.

Specifically, the firms ended their agreement to co-develop and...

Tags: Epilepsy, Arthritis




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