As pricing negotiations for Biogen Inc./Eisai Co. Ltd.’s newly approved Leqembi (lecanemab) for Alzheimer’s disease get underway at Japan’s Central Social Insurance Medical Council (Chuikyo), industry watchers see opportunity for potential drug price reform. Read More
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum. Read More
The Chinese government has invested $2.6 billion into building up the traditional Chinese medicine infrastructure and is actively exploring new models to integrate Chinese and Western medicine. Read More
In July 2023, South Korea’s Ministry of Trade, Industry and Energy ramped up efforts to kickstart the so-called “Bio Economy 2.0,” the newfound initiative that banks on the biopharmaceutical industry to potentially revitalize the country’s slowing economic and social growth. Highlighting four major areas – biopharmaceuticals, biomaterials, bioenergy and digital technologies – as the four “wheels” to carry the biopharma industry, the new plan underscored the government’s unwavering support for the sector while highlighting its vision to become the “number one bioeconomy” worldwide. Read More
As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field. Read More
National support for the biosimilar sector and the domestic industry’s efforts to increase production and sales may not be enough for South Korean biosimilar firms to box out competition in the ever-changing regulatory court of the U.S. Read More
After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date. Read More
Researchers who follow their instincts and achieve slow results while trying to break barriers have little support. They replace it with persistence. This is the story of Katalin Karikó and Drew Weissman. What was once a dream in their minds was later a success. Read More
January-August 2023 saw clinical trial data up 1.22% compared to the same time period last year. In the first eight months of this year, BioWorld reported on 2,314 drugs in phase I-III, compared to 2,286 in the same timeframe in 2022. The number of trial updates is down 13.24% from the 2,667 in 2021 and down from 2020’s 2,363, but up 20.46% from 2019’s 1,921. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Actinogen Medical, Affamed Therapeutics, Ascletis Pharma, Bionomics, Gracell Biotechnologies, JCR Pharmaceuticals, Mabwell Bioscience, Recce Pharmaceuticals, Remegen, Sagimet Biosciences. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Akeso, Astrazeneca, Adimab, Biocity Biopharma, Cosmo Pharmaceuticals, Evommune, Glenmark Speciality, Maruho, Pharmaceutical. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABM, Akeso, Alvotech, Ardelyx, Biogen, Daewoong Pharmaceuticals, Everest Medicines, Hutchmed, Remegen, Shionogi, Takeda Pharmaceutical. Read More