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During the first case management of this case in the Federal Court of Australia on 14 May 2024, it became clear that Cipla is challenging the patent term extension (PTE) on Novo Nordisk’s liraglutide formulation patent (AU 2004290862). The 9-month PTE was granted on 4 Augus...

On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).   The target action date for the FDA...

On 13 May 2024, Outlook Therapeutics announced that it submitted a Marketing Authorisation Application (MAA) in the UK for its ophthalmic formulation of bevacizumab (ONS-5010, LYTENAVA™) for the treatment of wet AMD. Outlook Therapeutics is seeking to achieve FDA, EU and MH...

On 13 May 2024, Boehringer Ingelheim (BI) announced a partnership with Cigna subsidiary Quallent Pharmaceuticals, under which Quallent will distribute high and low-concentration forms of BI’s citrate-free adalimumab biosimilar in the USA under its private label.  BI will co...

On 13 May 2024, Novo Holdings A/S announced the acquisition of a 60% majority stake in growing Austrian life sciences tools company Single Use Support.   The two co-founders of Single Use Support will each retain a 10% stake, and Danaher Corporation will hold the remaining ...

On 13 May 2024, Novo Nordisk announced positive results from the FRONTIER 2 trial, a 26-week phase 3a study evaluating the efficacy and safety of once-weekly and once-monthly subcutaneous administration of Mim8 for the treatment for haemophilia A.  The study demonstrated th...

On 6 May 2024, by order unsealed on 10 May 2024, the United States District Court for the District of Delaware refused to grant Alexion injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating parox...

On 10 May 2024, Xbrane and Stada announced the exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate.
Swedish biosimilar developer Xbrane and Germany’s STADA are responsible for completing the regulat...