Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical...
Drug
Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication...
Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
The Center for Drug Evaluation (CDE) has given the green light for the review of...
Hanx Biopharmaceuticals Receives NMPA Approval for HX009 Combination Therapy Phase II Trial
On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval...
European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States,...
Manufacturing Challenges for Novo Nordisk’s Ozempic Impact Diabetes and Obesity Treatments in Europe
Novo Nordisk (NYSE: NVO), a leading Danish pharmaceutical company, has released a joint statement with...
Skyline Therapeutics’ Gene Therapy Receives FDA Orphan Drug Designation for Retinitis Pigmentosa Treatment
Skyline Therapeutics, a biopharmaceutical company based in China, has received Orphan Drug Designation (ODD) from...
Innovent Biologics’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track...
Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received...
Jiangsu Hengrui and Chongqing Genrix Launch Anti-IL-17 Therapies for Psoriasis in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) and Chongqing Genrix Biopharmaceutical Co., Ltd, two leading...
Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
PARIS—French pharmaceutical giant Sanofi (NASDAQ: SNY) has reported mixed outcomes from three Phase III trials...
Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for...
Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval...
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough...
GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE)...
Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received...
China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor...
Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a...
Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE:...
Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US...