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On 17 May 2024, Regeneron filed a second complaint against Celltrion in the US District Court for the Northern District of West Virginia asserting infringement of 25 US patents relating to aflibercept (including method of treatment, formulation and manufacturing claims).  R...

On 16 May 2024, the FDA granted accelerated approval to Amgen’s IMDELLTRATM (tarlatamab-dlle) for small cell lung cancer that has progressed on or after platinum-based chemotherapy.  Tarlatamab is a Bispecific T-cell Engager (BiTE®) molecule designed to engage a patient’s o...

On 15 May 2024, Formycon announced its partnership with MS Pharma in MENA for the commercialisation of its aflibercept biosimilar FYB203.  Klinge Pharma GmbH, which holds the global commercialisation rights for Formycon’s FYB203, granted MS Pharma exclusive rights to licens...

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...