Japan-based Nxera Pharma, formerly known as Sosei Group or Sosei Heptares, has entered into an exclusive supply and distribution agreement with Handok Inc. to commercialise PIVLAZ (clazosentan sodium) 150 mg in South Korea.
Tokyo, Japan and Cambridge, UK, 15 April 2024 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – today announces that its operating business Nxera Pharma Korea (“NPK”) has entered into an exclusive supply and distribution agreement with Handok Inc. (“Handok”) to commercialize PIVLAZ™ (clazosentan sodium) 150 mg in South Korea.
PIVLAZ„¢, a new drug for prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH), approved in South KoreaPIVLAZ will become commercially available in South Korea in...
Idorsia Ltd (SIX: IDIA) today announces the initial findings of REACT, a Phase 3 study which investigated the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia, in patients following aneurysmal subarachnoid hemorrhage (aSAH). The study did not meet the primary endpoint. The company will fully analyze the efficacy and safety data to understand this unexpected result.
In Japan, PIVLAZâ„¢ (clazosentan) 150 mg, is indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid...
Results published in the Journal of Neurosurgery show that clazosentan significantly reduced the combined incidence of vasospasm-related morbidity and all-cause mortality post-aSAH with no unexpected...
Allschwil, Switzerland – January 20, 2022 Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announce that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved PIVLAZ™ (clazosentan sodium) 150 mg, a 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 PMDA approval of PIVLAZ is based on a dedicated Japanese Phase 3 program.
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).
Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aSAH.