NMPA Seeks Public Comment on Draft Proposal for Drug Re-Registration Procedures
The National Medical Products Administration (NMPA) of China has released a draft proposal for the...
Takeda Strikes Deal with AC Immune for Global Rights to Alzheimer’s Immunotherapies
Takeda Pharmaceutical Company Limited (NYSE: TAK) has entered into an agreement with AC Immune SA...
Protein Drug Developer B&K Co., Ltd from Qingdao Eyes Hong Kong IPO
B&K Co., Ltd, known as Bio-Bank Corp., a biopharmaceutical company specializing in protein drug development...
Novartis Shakes Up Executive Suite with Appointments and Transitions
The president of Novartis (NYSE: NVS)’ International Business Unit has this week declared a series...
Healingovation Raises Over RMB 60 Million in Pre-Series A++ Round for Aquablation Surgical Robot
Healingovation, a Beijing-based innovator in surgical robots and intelligent diagnostic and therapeutic equipment, has reportedly...
Brii Biosciences’ HBV Drug Candidates Receive NMPA’s Breakthrough Therapy Designations
Brii Biosciences Ltd (HKG: 2137) has announced that two of its hepatitis B virus (HBV)...
HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study,...
Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced...
NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in...
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced...
Subtle Medical Inc Closes USD 10 Million Series B+ Round to Accelerate Global Expansion
Subtle Medical Inc, a medical imaging specialist and Stanford University spin-off, has reportedly raised close...
Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China,...
NMPA Updates In Vitro Diagnostic Reagents Classification List for Enhanced Regulatory Oversigh
The National Medical Products Administration (NMPA) has coordinated the revision and release of the In...
Novartis Inks Deal to Acquire Mariana Oncology, Bolstering Radioligand Therapy Portfolio
Swiss pharmaceutical giant Novartis (NYSE: NVS) is poised to expand its oncology portfolio by acquiring...
China’s NMPA Revamps Medical Device Classification Rules to Improve Regulatory Efficiency
The National Medical Products Administration (NMPA) has revised the “Notice on Standardizing the Classification of...
BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors...
FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers...
BIO Survey Highlights Extensive Dependence on Chinese CDMOs in Life Sciences
The Biotechnology Innovation Organization (BIO), a US industry trade group, has completed a survey among...
Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
Yunnan Baiyao Group Co., Ltd (SHE: 000538), a traditional Chinese medicine (TCM) company based in...