CDE Issues New Requirements for IND Applications of Innovative Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) this week...
ADVANZ PHARMA Acquires Bayer’s Testoviron Commercial Rights in Key Markets
UK-based ADVANZ PHARMA announced the acquisition of commercial rights to testoviron from German giant Bayer...
Medtide’s IPO Raises HKD 514 Million to Expand Global Peptide CRDMO Services
Hangzhou-based Medtide Inc., a leading Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in polypeptides,...
Shanghai Innogen’s Diabetes Drug Patent for Efsubaglutide Alfa Fully Invalidated
Shanghai Innogen Pharmaceutical Technology Co., Ltd recently had its patent for efsubaglutide alfa (brand name:...
Shandong Xinhua Pharma Initiates Phase II Study of OAB-14 for Alzheimer’s Disease
China-based Shandong Xinhua Pharmaceutical Co., Ltd (SHE: 000756) announced the initiation of a Phase II...
Bayer Wins Beijing MPA Approval for MEDRAD Stellant D-CE Medical Device
German giant Bayer AG (ETR: BAYN) announced that it has received marketing approval from the...
Joincare Pharma Gets NMPA Green Light for Pediatric Influenza Drug JKN2301
China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) announced that it has received clinical...
Abbott Partners with Abu Dhabi Department of Health to Localize Pharma Production and Digital Health Solutions
US-based health care firm Abbott (NYSE: ABT) this week entered into a partnership with the...
Sanofi and Abu Dhabi Department of Health Collaborate to Accelerate Vaccine Development
France major Sanofi (NASDAQ: SNY) this week signed a Memorandum of Understanding (MoU) with the...
Platinum Life Biotech’s Ruibosheng First Prescribed in China for aGVHD Treatment
Beijing-based Platinum Life Biotech’s Ruibosheng (amimestrocel) has been first prescribed in China, following conditional marketing...
MindRank’s MDR-001 Phase IIb Study Achieves Clinical Endpoints for Weight Loss
China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced that the multi-center, 24-week Phase IIb...
Eccogene Announces First Patient Dosing in Phase Ib Study of AZD5004/ECC5004 in China
Sino-US firm Eccogene Inc., a partner of UK major AstraZeneca (AZ, NASDAQ: AZN), announced the...
Simcere Zaiming Initiates US Phase I Study of SIM0500 for Relapsed/Refractory Multiple Myeloma
China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary Simcere Zaiming announced the first patient dosing...
FDA Launches ‘Elsa’ AI Tool to Enhance Staff Efficiency in Regulatory Processes
The U.S. Food and Drug Administration (FDA) announced the launch of an artificial intelligence (AI)...
FDA Launches Immediate Review of Clinical Trials Involving Cell Transfer to Hostile Countries
The U.S. Food and Drug Administration (FDA) this week announced an immediate review of new...
Gilead’s Yeztugo Approved by FDA as First Six-Monthly Injectable HIV PrEP
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has received market approval from the...
Fosun Pharma’s Fumaining Launches Clinically for Rare Disease Treatment in China
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd.’s (HKG: 2196, SHA: 600196) in-house developed Category 1 drug...
FDA Launches Commissioner’s National Priority Voucher Program for Accelerated Drug Reviews
The U.S. Food and Drug Administration (FDA) this week announced the launch of the Commissioner’s...
Hengrui Pharma’s Ruitanning Enters Clinical Use for Chemo-Induced Nausea and Vomiting
China’s Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the prescription of its Category 1...
Merck’s Clesrovimab Gears Up for Priority Review in China for RSV Prevention
China’s Center for Drug Evaluation (CDE) website indicates that US giant Merck, Sharp & Dohme’s...