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On 30 July 2024, Biogen and Eisai announced results from their open label extension study of Leqembi® (lecanemab) in early Alzheimer’s Disease.  The data reportedly shows that three years of continuous treatment with lecanemab reduced clinical decline, demonstrating a conti...

On 30 July 2024, Mr Justice Meade of the High Court of Justice of England and Wales delivered his decision in Samsung Bioepis UK Limited’s case against Janssen Biotech Inc seeking to invalidate the UK counterpart patent of European Patent No. EP 3883606 on the grounds of no...

On 30 July 2024, Bio-Thera Solutions announced that the European Medicines Agency (EMA) has approved Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab), for treating various cancers.

In September 2021, Bio-Thera and Sandoz entered an agreement under ...

On 30 July 2024, Roche announced that the European Commission has approved Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion (RVO).  This follows the positive CHMP opinion for the indication in June 2024.

This is the first approval for a bis...

On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed mul...

Five days after Bio-Thera announced the start of its integrated Phase I/III trials for BAT3306 (pembrolizumab), on 30 July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®.  The “Lotus” ...

A United States federal grand jury has indicted a person from India for allegedly selling counterfeit cancer drugs and shipping them to Houston. The counterfeits are reported to include fake versions of MSD’s Keytruda®, Pfizer’s Adcetris® and Bristol Myers Squibb’s Opdivo®....

On 29 July 2024, Roche Canada announced that Health Canada has approved Vabysmo® (faricimab) injection for macular edema secondary to retinal vein occlusion (RVO).   This is the third indication for Vabysmo® in Canada, following approvals for AMD and DME.

Vabysmo® ha...

On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan (marketed by Daiichi Sankyo/AstraZeneca as Enhertu®) for treatment of HER2-low breast cancer patients after chemo...