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MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its R-ONE vascular intervention surgical robot. The robot was introduced by Cathbot, a joint venture between MicroPort and French firm Robocath S.A.S in China. R-ONE, a…
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Eisai and BioArctic Set December Launch for Alzheimer’s Drug Leqembi in Japan
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Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) have announced the launch of Leqembi (lecanemab) in the Japanese market on December 20. The amyloid-beta (Aβ)-targeting drug received its second global approval in Japan earlier this year and has been incorporated into the National Health Insurance (NHI) system. Leqembi is indicated for…
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Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
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China’s 2023 NRDL Expands Coverage with 126 New Drugs, Aims for Savings and Accessibility
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The National Healthcare Security Administration (NHSA) has released the finalized National Reimbursement Drug List (NRDL) for 2023, adding 126 new drugs to the list. The new additions include 21 oncology drugs, 17 COVID-19 treatments, 15 drugs for diabetes, mental illness, and rheumatoid/immune diseases, and 15 rare disease drugs. The NRDL…
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AstraZeneca Acquires Icosavax to Boost Infectious Disease Pipeline with VLP Vaccine Technology
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced the acquisition of US vaccines specialist Icosavax (NASDAQ: ICVX), including its protein virus-like particle (VLP) platform. AstraZeneca will pay approximately USD 800 million upfront for all outstanding shares, plus about USD 300 million in milestone payments. The acquisition is set to…
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BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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Hong Kong Aims for “First-Level Approvals” with New Drug Regulatory Institution
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Hong Kong is taking steps to establish a drug regulatory institution that will permit “first-level approvals,” according to the Chief Executive’s Policy Address for 2023. This initiative means that drug and device market approval filings will be able to secure approval based on clinical data directly, without the need for…
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Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent…
