Category: Europe

April 28, 2022 Off

Novartis Announces Positive Phase III Results for its ESCC Drug

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Novartis has announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression.

April 25, 2022 Off

Dr Catarina Edfjäll joins Arex Advisor

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Dr Catarina Edfjäll joins Arex as Senior Advisor in Basel, Switzerland. She will strengthen the company’s expertise and capabilities within global pharmaceutical development leadership in areas such as regulatory affairs strategy, portfolio management, orphan designations, new product development and registration.

April 22, 2022 Off

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an extension of the Novo Nordisk’s NovoSeven (eptacog alfa) label to include treatment of women suffering from severe haemorrhage after giving birth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding.

April 22, 2022 Off

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.