AstraZeneca announced that the FDA has approved Enhertu® (trastuzumab deruxtecan) a HER2-directed antibody drug conjugate jointly developed and commercialised by AZ and Daiichi Sankyo, for the treatment of adult patients with unresectable or metastatic HER2-positive breast ...
Opthea Limited presented data for OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in combination with ranibizumab for polypoidal choroidal vasculopathy at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting. Opthea reported that OPT-302 used in combina...
Korea Biomedical Review reported that Boditech Med has obtained approval in Korea for its AFIAS infliximab system. AFIAS infliximab is a therapeutic drug monitoring device used to measure infliximab levels in the blood and check for adverse reactions.
Depression, anxiety and related disorders are serious conditions whose treatment is – in many cases – not adequately addressed by existing psychiatric or psychological t...
Introduction
Medicinal cannabis is now widely available in Australia. However, the vast majority of medicinal cannabis products are not registered on the Australian Register ...
Amneal published its Q1 2022 financial results, reporting a 1% increase YoY in net revenue. Amneal announced that it plans to expand into high growth areas including biosimilars and injectables.
The Kennedy Institute (Oxford University) published the results of Ph IIb trials of adalimumab in Dupuytren’s disease. The researchers reported no related serious adverse events, and that the treatment was effective. Although the half-life of adalimumab is two or three we...
21 Apr 22 | AU | Australia’s TGA granted orphan drug designation to Roche’s glofitamab. The TGA also provided approval for Roche to apply for registration using the provisional app...
Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1.
Korea Biomedical Review reported that Celltrion has a licence from AbbVie enabling the launch of Yuflyma® (Celltrion’s biosimilar adalimumab) in the US from July 2023. Celltrion expects to receive approval for Yuflyma® this year. Celltrion previously announced in February...
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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