Roche notified Australia’s TGA of shortages of multiple presentations of Actemra® (tocilizumab). Tocilizumab has been used off-label for COVID-19, driving global demand. The TGA made a number of recommendations for patients currently treated with Actemra®, including switchi...
Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).
A new study published in The Lancet reported that Boehringer Ingelheim’s BI 695501 (biosimilar adalimumab) has similar safety and efficacy to reference adalimumab in patients with Crohn’s disease.
Date: 12 August 2021Court: Federal Court of AustraliaJudge: Jagot J
Background
Under Australian law, a patent term extension (PTE) must be based on the “first regulator...
Enzene Biosciences announced that India’s DCGI has approved its biosimilar romiplostim for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.
A new study published in the The Lancet reported that the safety and efficacy of Boehringer Ingelheim’s BI695501 (adalimumab biosimilar) in patients with Crohn’s disease is similar to reference adalimumab.
Opthea commenced recruitment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration.
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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