Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...
CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials
The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key...
Chinese Pharma Consortium Eyes Poland’s Neuca in Strategic European Market Acquisition
A consortium of China-based pharmaceutical companies, potentially including the state-owned giant Sinopharm (HKG: 1099), is...
Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National...
CanSino Biologics to Expand Southeast Asian Presence with Solution Group Berhad Stake
China-based CanSino Biologics (SHA: 688185, HKG: 6185) is poised to acquire an undisclosed amount of...
Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital...
Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril,...
Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...
CSH MEDI Secures Series A+ Funding to Advance Biomagnetic Equipment Technology
CSH MEDI, a Shanghai-based biomagnetic equipment manufacturer, has reportedly raised close to RMB 100 million...
Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)...
Luye Pharma Group’s Subsidiary Boan Biotechnology Reports 18.4% Revenue Growth in H1 2023
China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955),...
CSRC Aims to Rebalance Primary and Secondary Markets with New Regulatory Measures
The China Securities Regulatory Commission (CSRC) has released a document with the aim of “rebalancing”...
Neurodawn Pharmaceutical and China Medical System Holdings Ink Licensing Deal for Y-3
Nanjing-based Neurodawn Pharmaceutical Co., Ltd has entered into a significant licensing deal with China Medical...
Jiangsu Kanion Pharmaceutical Gets NMPA Approval for SLE Clinical Trial with KYS202002A
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent China-based pharmaceutical company, has announced that...
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon,...
China Releases Third List of Pediatric Drugs to Guide Development and Filings
The National Health Commission (NHC), National Healthcare Security Administration, National Medical Products Administration (NMPA), and...
NMPA Releases 72nd Batch of Reference Drugs for GQCE
The National Medical Products Administration (NMPA) has released the 72nd batch of reference drugs for...
Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory...
FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ:...
AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and...