J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Drug
Eli Lilly’s Efsitora Meets Key Endpoints in Phase III Trials for Type 2 Diabetes
US major Eli Lilly and Company (NYSE: LLY) presented detailed results from the Phase III...
Johnson & Johnson’s Imbruvica Secures CHMP Recommendation for Expanded MCL Use
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products...
Bayer’s Nubeqa Receives Positive CHMP Opinion for mHSPC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced last week that the European Medicines Agency...
Sichuan Huiyu’s CDCP1-Targeted ADC HY0001a Gets NMPA Clinical Trial Approval
China-based Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553) announced that it has received clinical trial...
Changshan Biochemical Receives NMPA Clearance for Albenatide in Weight Loss Trials
China’s Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) announced that it has received...
ImmuneOnco Receives NMPA Approval for IMC-003/IMM72 in Pulmonary Arterial Hypertension Trial
China-based ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) announced that it has received clinical trial...
Simcere Pharma’s Quviviq Receives NMPA Approval for Insomnia Treatment
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) revealed that its marketing approval filing for Quviviq...
Sanofi and Regeneron Win FDA Approval for Dupixent in Bullous Pemphigoid Treatment
France major Sanofi (NASDAQ: SNY) and US-based biopharma Regeneron (NASDAQ: REGN) announced that Dupixent (dupilumab)...
Zai Lab’s Partner argenx Secures EU Approval for Vygart in CIDP Treatment
China-based Zai Lab Limited’s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced...
CanSino Biologics’ PCV13i Vaccine Gains NMPA Approval
China-based CanSino Biologics Inc., (HKG: 6185) announced that the National Medical Products Administration (NMPA) has...
Zhongsheng Pharma’s RAY1225 Enters Phase III Trial for Obesity/Overweight Treatment
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced the initiation of the multi-center, randomized,...
Dizal’s Phase III Trial Completes Enrollment for Shuwozhe in EGFR Exon20ins NSCLC
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced the completion of patient enrollment for its...
Shanghai Pharmaceuticals Receives Thai FDA Approval for Pregabalin Capsules
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that it has...
Wantai Biological Launches Phase III Trial for VZV-7D Varicella Vaccine
China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation of...
MSD Initiates IDeate-Prostate01 Phase III Trial of Ifinatamab Deruxtecan for mCRPC
Merck, Sharp & Dohme (MSD, NYSE: MRK) this week announced the first patient dosing in...
Changchun BCHT Gains NMPA Approval for BK-01 Adjuvanted Influenza Vaccine
China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) announced that it has received clinical trial...
NMPA’s CDE Reports 4,900 Clinical Trial Filings for Innovative Drugs in 2024
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released its...
Beijing Science Sun Pharma Inks RMB20M Drug Tech Transfer Pact for NeoAB33 Project
Beijing Science Sun Pharmaceutical Co., Ltd (SHE: 300485) announced a Drug Technology Transfer Agreement with...
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...