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Sandoz
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Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
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An ophthalmic gene therapy company aiming to restore and improve the vision of patients with a range of prevalent and rare retinal diseases that result in blindness.
Latest News & Features of interest to Sandoz
Biotechnology
Johnson & Johnson has announced data highlighting that Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM), regardless of transplant status. 9 December 2024
Biotechnology
Dizal has announced the latest data from a pooled safety and efficacy analysis of DZD8586, a non-covalent blood-brain barrier (BBB) penetrant LYN/BTK dual inhibitor, in B-cell non-Hodgkin lymphoma (B-NHL). 9 December 2024
Biotechnology
After previously rejecting an application for this indication, the US Food and Drug Administration (FDA) has now accepted for review data from the MATINEE study to support the regulatory review process to obtain a new indication for Nucala (mepolizumab). 9 December 2024
Biotechnology
AbbVie has announced updated results from the Phase Ib/II EPCORE NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide and rituximab (R2) in relapsed or refractory (R/R) follicular lymphoma (FL). 9 December 2024
Biotechnology
Positive results from the AMPLIFY Phase III trial have shown that adding AstraZeneca’s Calquence (acalabrutinib) to venetoclax led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL). 9 December 2024
Biosimilars
Germany’s Formycon has entered into a licensing and supply agreement with MS Pharma for the commercialization of FYB202, Formycon’s biosimilar to Johnson & Johnson’s Stelara (ustekinumab), in the Middle East and North Africa (MENA region). 9 December 2024
Biotechnology
Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with lung cancer. 9 December 2024
Biotechnology
Positive new five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL) were released on Sunday by Swiss pharma giant Roche. 9 December 2024
Biotechnology
Netherlands-based clinical-stage biotech Merus on Saturday announced interim clinical data as of a July 5, 2024 data cutoff from the ongoing Phase I/II trial of petosemtamab, a Biclonics targeting EGFR and LGR5, in previously treated (second line [2L]+) patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC). 9 December 2024
Biotechnology
Dutch biotech Citryll, which is focused on treating immune-mediated inflammatory diseases by targeting neutrophil extracellular traps (NETs), today announced the successful closing of an oversubscribed 85 million euros ($89.8 million) Series B fundraise. 9 December 2024
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Biotechnology
The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024
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GE Healthcare has announced plans to acquire from Sumitomo Chemical the half of Nihon Medi-Physics (NMP) that it doesn’t own. 5 December 2024
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