Pharmaceuticals, Biotechnology and Life Sciences
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.
Ultimovacs ASA has received a Notice of Allowance from the United States Patent and Trademarks Office (USPTO) concerning its US patent application 16/306,352 on the use of vaccine-checkpoint inhibitor combinations to treat cancer.
AstraZeneca has announced detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for AbbVie’s risankizumab for treatment of adults and adolescents (16-17 years) with Crohn’s Disease (CD) who have had an inadequate response to, lost response to or were intolerant or contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab.
Moderna has announced new clinical data on its bivalent COVID-19 booster platform including data on the company’s first bivalent booster candidate, mRNA-1273.211, which includes mutations found in the Beta variant of concern, several of which have been persistent in more recent variants of concern including Omicron.
The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GlaxoSmithKline’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).
Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan have announced that PIVLAZ (clazosentan) is now available to physicians in Japan to start treating aSAH patients. PIVLAZ is a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm.
Jackson ImmunoResearch, manufacturer of secondary antibodies and immunoreagents for the life science market, announces a new range of detection reagents that offer superior imaging quality.