Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) has notified Homology that the clinical hold on its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) has been lifted.
Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Novartis said.
Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have announced that the European Commission has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients.
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.
Basilea Pharmaceutica Ltd has entered into a licensing agreement with the U.S.-based company, Fox Chase Chemical Diversity Center, Inc. (FCCDC), for a preclinical program on novel first-in-class broad spectrum antifungals with activity against difficult-to-treat mold infections.
ViGeneron GmbH, a next-generation gene therapy company, has announced a follow-on collaboration with Daiichi Sankyo Company, Limited to utilize ViGeneron’s novel engineered recombinant adeno-associated virus vectors (vgAAVs) to address an undisclosed target for the treatment of prevalent eye diseases.
APEIRON Biologics AG has announced that the annual general meeting held yesterday has approved the new structure of the group…
Valneva SE and Pfizer Inc. have reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
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.
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.