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SK Biopharm's anti-epileptic drug wins EU drug agency's positive opinion

SK Biopharm s anti-epileptic drug wins EU drug agency s positive opinion ....

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Cenobamate Receives Positive CHMP Opinion for Adjunctive Treatment of Focal-Onset (Partial-Onset) Seizures

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PANGYO, GYEONGGI PROVINCE, Korea, Jan. 29, 2021 /PRNewswire/
SK Biopharmaceuticals announced that the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-seizure medications (ASMs). The European Commission (EC), which is authorized to approve medicines in the European Union, is expected to issue its decision within approximately 67 days of receipt of the CHMP opinion.
SK Biopharmaceuticals and Arvelle Therapeutics entered into a licensing agreement in 2019 for Arvelle to commercialize SK Biopharmaceuticals cenobamate in Europe. Cenobamate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onse ....

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ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults*

ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults
January 29, 2021 12:20 ET
| Source:
Arvelle Therapeutics
Arvelle Therapeutics
Positive CHMP opinion is an important milestone for Arvelle Therapeutics and cenobamate
When approved, cenobamate will provide new hope in helping adult patients with uncontrolled focal epilepsy move closer to the goal of seizure reduction and seizure freedom
ZUG, Switzerland, Jan. 29, 2021 (GLOBE NEWSWIRE) Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from central nervous system (CNS) disorders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of cenobamate for the ....

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Insomniac whose treatment resulted in day-long erection loses lawsuit after becoming impotent

WILMINGTON, Del. (Legal Newsline) – A man who sought to cure his insomnia and instead ended up impotent can’t sue the maker of the medication he took – a drug known to cause prolonged erections as a side effect.
Delaware Superior Court Judge Paul Wallace ruled for Teva Pharmaceuticals on Jan. 15 in the lawsuit brought by Daniel Camejo, a California man who used Trazodone in 2017 and developed priapism. He didn’t know the condition was a side effect and didn’t seek medical attention for more than 24 hours.
At age 50, he ended up impotent because of it. The drug’s label stated, in capital letters, the risk of priapism that could result impotence. ....

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Italian Economic Diplomacy 15 January: breaking news from around the world

Italian Economic Diplomacy 15 January: breaking news from around the world
esteri.it - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from esteri.it Daily Mail and Mail on Sunday newspapers.

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