Samsung Bioepis Co, Ltd announced that the US Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. […]
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Vertex Pharmaceuticals Limited announced that the European Commission has granted approval of the label extension for Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. “Today’s approval by the European Commission brings […]
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Bayer Animal Health announces the launch of Coraxis (moxidectin) topical solution for dogs, a prescription-only, monthly transdermal product that prevents heartworm disease and treats and controls hookworms, roundworms, and whipworms in dogs. The product is expected to be available for sale in early February. “Coraxis is a unique addition to the veterinarian’s anti-parasite toolbox,” said […]
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BerGenBio ASA announces that the first patient has been dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting antibody drug conjugate (ADC), in patients with advanced solid tumours. ADCT-601 is composed of a humanised monoclonal antibody against human AXL (BGB601) discovered by BerGenBio, conjugated to […]
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