Category: Regions

FDA Approves BMS’s Camzyos for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM)
April 29, 2022 Off

FDA Approves BMS’s Camzyos for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM)

By Author

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

Novartis Announces Positive Phase III Results for its ESCC Drug
April 28, 2022 Off

Novartis Announces Positive Phase III Results for its ESCC Drug

By Author

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.

Dr Catarina Edfjäll joins Arex Advisor
April 25, 2022 Off

Dr Catarina Edfjäll joins Arex Advisor

By Author

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.

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA
April 22, 2022 Off

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

By Author

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.