December 21, 2020 Oral XPOVIO® Approval as Combination Therapy in Patients with Multiple Myeloma After At Least One Prior Therapy Significantly Expands the XPOVIO® Addressable Patient Population - Oral XPOVIO® is Now the Only Approved Multiple Myeloma Drug Indicated as Part of a Once-Weekly Bortezomib Combination Regimen - First Multiple Myeloma Drug with a New Mechanism of Action Approved by the FDA in the Second-Line Setting Since 2016 - FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date -
SHANGHAI and HONG KONG, Dec. 21, 2020 /PRNewswire/ Antengene Corporation Limited ( Antengene , SEHK: 6996.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for oral XPOVIO
VFMCRP and ChemoCentryx Provide Topline Results From ACCOLADE Trial of Avacopan in C3 Glomerulopathy Including Improved Estimated Glomerular Filtration Rate (eGFR) oaoa.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from oaoa.com Daily Mail and Mail on Sunday newspapers.
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As in ANCA vasculitis, avacopan demonstrated statistically significant improvement in renal function as measured by eGFR compared to placebo over 26 weeks of blinded treatment
The change from baseline to week 26 in C3 glomerulopathy histologic index (C3G HI) for disease activity (primary endpoint) was not statistically different between the two treatment groups, while the C3G HI for disease chronicity (measuring progression of fibrosis) shows significant benefit for avacopan versus placebo
Avacopan safe and well tolerated in C3G patients
ChemoCentryx and VFMCRP plan to discuss registration pathway with regulatory agencies in US and EU
Regulatory News:
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FibroGen Provides Regulatory Update on Roxadustat – IT Business Net itbusinessnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from itbusinessnet.com Daily Mail and Mail on Sunday newspapers.
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TLC Provides Corporate Update at Investor Conference
TLCDecember 18, 2020 GMT
Patient enrollment of EXCELLENCE pivotal trial reaches 98%
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. 18, 2020 (GLOBE NEWSWIRE) TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, held a virtual investor conference earlier today under the invitation of KGI Securities, and provided an update on the company’s pipeline as well as corporate strategy for the year ahead. George Yeh, President of TLC, commenced the conference and welcomed the company’s new Chief Business Officer, Mr. Tom Bliss. With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Mr. Yeh then proceeded to provide a company and