SBS News reported the Australian Government has committed $6 million to the research and development of three potential COVID-19 vaccines. The University of Melbourne will receive $3 million for the development of two vaccines, and the University of Sydney will receive $3 m...
Regenxbio announces it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.
The Australian Patent Office, in Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, has emphatically confirmed that a patent term extension (PTE) request must be based on the first r...
The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.
Lotus Pharma announces it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical t...
Significant biosimilar activities this week include
08 Sep 20 | The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar ...
AstraZeneca announced it has resumed clinical trials in the UK and Brazil following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.
A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and ...
Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.
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