Huahai Pharmaceutical’s Adalimumab Biosimilar Accepted by China’s CDE for Review
On December 14th, the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE)...
Drug
Insilico Medicine Receives $10 Million Milestone Payment for XL309 Clinical Progress
Chengdu-based, generative artificial intelligence (AI)-driven clinical stage biotech company, Insilico Medicine, has announced the receipt...
Ascendis Pharma’s TransCon hGH sBLA for Adult GHD Accepted by FDA
Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) has announced that the US Food and Drug Administration...
Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA)...
Bayer AG Initiates Phase I Study Combining BAY3498264 with Sotorasib for KRAS-Mutated Tumors
Germany-based pharmaceutical giant Bayer AG (ETR: BAYN) has announced the initiation of a Phase I...
CureGene Pharmaceutical Gets NMPA Approval for Antiplatelet Drug CG-0255
Shanghai-based CureGene Pharmaceutical has announced receiving clinical trial approval from China’s National Medical Products Administration...
Pfizer’s Ibrance Demonstrates Significant PFS Improvement in Phase III PATINA Trial
US pharmaceutical major Pfizer Inc. (NYSE: PFE) and Alliance Foundation Trials, LLC (AFT) have announced...
Gan & Lee Pharmaceuticals Gets FDA Approval for GZR18 Obesity/Overweight Phase II Study
China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from...
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib),...
HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment...
HuidaGene Therapeutics Launches MUSCLE Study for CRISPR Therapy in Duchenne Muscular Dystrophy
Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced the initiation of the MUSCLE study for...
Transcenta’s LIV-1 ADCs Show Promising Results in Pre-Clinical Breast Cancer Study
China-based biotech company Transcenta Holdings Ltd (HKG: 6628) announced updated results from a pre-clinical study...
ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving...
Jiangsu Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-4729 Peptide Drug
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced the receipt of clinical clearance from...
AstraZeneca’s Lynparza Shows Sustained Improvements in OlympiA Phase III Study
UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) has updated data from the Phase III OlympiA...
Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates
Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food...
Eli Lilly’s Imlunestrant Reduces Disease Progression in ER+/HER2- Advanced Breast Cancer: EMBER-3 Study
US pharmaceutical major Eli Lilly and Company (NYSE: LLY) has published results from the Phase...
Arvinas and Pfizer Present Positive TACTIVE-U Sub-Study Data at SABCS 2024
Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) have jointly presented preliminary data...
Novartis’ Kisqali Shows Sustained Efficacy in NATALEE Study at SABCS 2024
Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE...
Legend Biotech’s Carvykti Demonstrates High MRD Negativity Rates in Phase III CARTITUDE-4 Trial
China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD)...