The European Commission has approved the Menarini Group’s Orsedu (elacestrant) as a monotherapy for the treatment of postmenopausal women and men with breast cancer.
The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
Dutch biotech, Byondis, today announced positive topline results from a Phase 3 study, which it says confirms the safety and efficacy of its antibody drug conjugate (ADC) - SYD985 - as a treatment for patients with pretreated HER2-positive locally advanced...
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
A new study suggests that CAR T-cells, which are already used to treat certain blood cancers, may also be successful against solid tumors if combined with other immunotherapeutic approaches.
Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
Halozyme Therapeutics announced that a subcutaneous formulation of trastuzumab created with Halozyme’s technology, for the treatment of breast cancer, has received approval from Health Canada.
BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.
Mylan says it will continue to manufacture and sell its Indian version of trastuzumab despite an injunction by Roche restricting reference to it as a biosimilar of Herceptin.
Biocon has defended criticism of the high price of its Trastuzumab biosimilar which will become the world's first copycat version of Roche’s Herceptin when launched next month.
Kadcyla has become the second antibody-drug conjugate (ADC) to be available in Europe, triggering a $5m milestone payment by Roche to technology partner Immunogen.
