Tags : Australia

COVID-19 Regulatory

Moderna’s Spikevax Receives TGA’s Provisional Approval to Treat COVID-19 in

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 […]Read More


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 […]Read More


Samsung Bioepis Expand its Footprints with the Launch of Hadlima

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 […]Read More


Cipla Expands its Partnership with Alvotech to Commercialize Biosimilars in

Shots: The companies collaborated for marketing and distribution of four biosimilars in Australia and New Zealand Cipla Gulf will be responsible for commercialization of patented biosimilars of the biologic medicine brands, covering therapeutic categories across immunology, osteoporosis, oncology as well as ophthalmology Alvotech will manufacture and develop the products and will be distributed by Cipla […]Read More


Biocon and Mylan Launch Fulphila (biosimilar, Pegfilgrastim) in Australia

Shots: The companies launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) in Australia. The biosimilar received TGA’s approval to treat cancer patients following the CT, to decrease the duration of neutropenia and to reduce the incidence of infections, as manifested by febrile neutropenia The approval is based on analytical, clinical and nonclinical data which demonstrated that […]Read More