Read our latest updates & insights

On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for ma...

On 8 July 2024, Just – Evotec, a subsidiary of Evotec SE, announced that it has expanded its partnership with Sandoz to develop and manufacture multiple biosimilars.  The deal was first entered into in May 2023 and is designed to utilise Just – Evotec’s AI driven drug...

On 8 July 2024, Genentech announced that the FDA has approved the relaunch of Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, which is used for treating nAMD.

The FDA first approved Susvimo® in October 2021.  However, in Oct...

On 8 July 2024, Eli Lilly and Morphic Holding announced that Eli Lilly has agreed to acquire Morphic for US $3.2b.  Morphic Holding is a US biopharmaceutical company developing oral integrin therapies for treating chronic diseases.  The acquisition has been approved by the ...

On 8 July 2024, Ligand Pharmaceuticals and Austrian-based APEIRON Biologics announced that Ligan will acquire APEIRON for US$100m.  Ligand will also pay APEIRON shareholders additional amounts of up to US$28m based on future commercial and regulatory events.  The acquisitio...

On 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small ...

On 5 July 2024, Roche announced that the FDA has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6 mg) for nAMD, diabetic macular oedema and macular oedema following retinal vein occlusion.  Roche reports that the product is the first PFS with an FDA-approved bispec...

On 4 July 2024, Celltrion announced that it received final approval from the European Commission for an additional dosing regimen and dose increase for Remsima SC® (infliximab). The approval comes almost a month after the CHMP issued a positive opinion for the new dosing. <...

Novo Nordisk’s weekly injection insulin Icodec is reported as nearing approval in India following a 19 June 2024 recommendation by the Subject Expert Committee under India’s drug controller to permit the import and sale of the drug.  This news follows the approval of Novo N...

On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophil...