Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC.
Singapore’s Health Science Authority is rolling out new drug substance evidence requirements following consultations with stakeholders, and drugmakers will have one year to comply with the new regulations.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
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.
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.
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.
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.
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.
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.
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