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BioWorld - Wednesday, March 22, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory front for May 21, 2020

May 21, 2020
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for May 21, 2020

May 21, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Alethia, Anavex, Appili, Astellas, Calcimedica, Chiesi, Fibrogen, Genexine, I-Mab, Passage Bio.
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Regulatory front for May 20, 2020

May 20, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetion, Boston Scientific Neuromodulation, Nevro.
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Regulatory actions for May 20, 2020

May 20, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter.
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FDA Approved stamp with pills

FDA's approval of Lynparza for mCPRC shades Rubraca win

May 20, 2020
By Michael Fitzhugh
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Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
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Digital cardiology illustration

AI-powered diagnostics repurposed for rapid assessment and triage of seriously ill COVID-19 patients

May 20, 2020
By Nuala Moran
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LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
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Regulatory front for May 20, 2020

May 20, 2020
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The latest global regulatory news, changes and updates affecting biopharma, including: International Trading Pharmaceuticals Laboratories Inc.
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FDA approves Lynparza for HRR gene-mutated castration-resistant prostate cancer

May 20, 2020
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Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 19, 2020
By Elise Mak
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BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
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Approved stamp

Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

May 19, 2020
By David Ho
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HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.
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