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Jul 31, 2024
On 31 July 2024, Zydus Lifesciences announced it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market Mamitra™, biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer. The...
Jul 31, 2024
The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024. Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to...
Jul 31, 2024
As previously reported, on 9 April 2024, Novartis and Genentech commenced proceedings in the Dusseldorf Local Division of the UPC (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion in relation to EP 2805248 regarding...
Jul 31, 2024
On 31 July 2024, Teva announced that its Q2 2024 revenues increased by 7% to US$4.2 billion. While much of this is attributed to growth in Teva’s generics business, Teva notes key biosimilar developments, including the May 2024 launch of Teva/Alvotech’s Simlandi®...
Jul 30, 2024
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...
Jul 30, 2024
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...
Jul 30, 2024
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...
Jul 30, 2024
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...
Jul 30, 2024
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...
Jul 30, 2024
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...
Jul 29, 2024
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...
Jul 29, 2024
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® has...
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