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Pfizer’s Herceptin (trastuzumab) biosimlar Trazimera has been approved by the European Comission.

Pfizer has announced the European Commission (EC) has approved TRAZIMERA,  a biosimilar to Herceptin  (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  This approval follows the recommendation from…

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Onpattro (patisiran), a new drug that addresses unmet medical need for treatment of hereditary transthyretin amyloidosis

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy (a condition in…

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AbbVie Receives U.S. FDA Approval of ORILISSA (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis

AbbVie , a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc., announced that the U.S. Food and Drug Administration (FDA) approved ORILISSA (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate…

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Third Novartis Phase III trial shows Kisqali (ribociclib) combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer

Novartis has announced positive results from the third Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer. MONALEESA-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive, human…

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