PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region.
As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s TGA.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s ARCoV had acceptable safety and induced a strong immune response, partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine.
North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
Edigene Inc. has extended a long-running partnership with an academic lab at the Chinese Academy of Medical Sciences and Peking Union Medical College with the goal of co-developing hematopoietic stem cell regenerative therapies and technology.
Samsung Biologics Co. Ltd. has agreed to buy out Biogen Inc.’s stake in the joint venture Samsung Bioepis Co. Ltd. for $2.3 billion. Biogen will receive $1 billion in cash at closing and $1.25 billion in deferred payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is also expected to receive up to $50 million upon achievement of certain commercial milestones.
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