Pharmaceuticals, Biotechnology and Life Sciences
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.
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.
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.
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.