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Idorsia submits NDA for clazosentan to Japanese PMDA
Idorsia Pharmaceuticals LtdMarch 1, 2021 GMT
Allschwil, Switzerland – March 1, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receiv
Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA
Allschwil, Switzerland - March 1, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ET
A) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receive continuous infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following the onset of aSAH. The
Japan Avails US$4 5 million To Alleviate Hunger In Female-Headed Households newzimbabwe.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newzimbabwe.com Daily Mail and Mail on Sunday newspapers.
In October, the first and surely last
Midway Poker Tour event was marred by a silver payout controversy that has left a dozen players shorted on their advertised payouts by a combined $55,060. Tour founder
Dan Bekavac, who the day after the debacle pledged to make players whole, subsequently ghosted players and disappeared â until this weekend.
Without offering players or the community any sort of update in three months, Bekavac resurfaced at the MSPT Grand Falls as a player in the $1,100 Main Event. Bekavac has not responded to
PokerNewsâ various attempts at contact, and when another player tried to breach the topic on-site, it was reported that Bekavac âseemed madâ and apparently âwasnât having it.â