Australia

Moderna’s Spikevax Receives TGA’s Provisional Approval to Treat COVID-19 in Patients Aged 12-17 Years

Shots: TGA has provisionally approved the use of Moderna’s Spikevax (elasomeran) in individuals aged ≥12yrs. The decision follows the provisional approval granted by the TGA to Spikevax on Aug 09, 2021 for use in individuals aged ≥18yrs. Provisional approval for this group follows the data supporting the efficacy & safety of the vaccine. The recommended …

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Imugene HER2 vaccine hits target in stomach cancer trial

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response …

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BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the …

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Glaukos Expands its Partnership with Santen for Preserflo MicroShunt

Shots: The companies enter into a license agreement for the Preserflo MicroShunt superseding the previous collaboration between the two parties Glaukos get exclusive commercialization rights for the MicroShunt in the US, Australia, New Zealand, Canada, Brazil, Mexico and the remainder of Latin America and gain full control over all development activities for the MicroShunt in …

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Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia Hadlima is Samsung Bioepis’ third anti-TNF biosimilar launched in Australia, following the launch of Brenzys (etanercept) and …

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Cancer Risk from Arsenic in Rice and Seaweed

A daily half-cup of cooked rice may carry a hundred times the acceptable cancer risk of arsenic. What about seaweed from the coast of Maine? “At one point during the reign of King Cotton, farmers in the south central United States controlled boll weevils with arsenic-based pesticides, and residual arsenic still contaminates the soil.” Different …

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Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Shots: Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per …

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Policy makers should ‘set their sights higher’ on U.S. drug pricing regulations, researchers say

A review published in JAMA found that bills introduced into the House and Senate don’t go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.