The European Medicines Agency has recommended the approval of Dengvaxia (dengue tetravalent vaccine) for the prevention of dengue, the most common mosquito-borne viral disease affecting people worldwide. The vaccine is for the prevention of dengue caused by the virus serotypes 1,2,3 and 4 in people between the ages of nine and 45 and who have already had a prior infection.
The Parker Institute for Cancer Immunotherapy has invested in a chimeric antigen receptor T cell technology developed by Xyphos Biosciences Inc of South San Francisco, US which claims the platform is safer and more effective than existing approaches. Financial terms of the collaboration were not disclosed.
Amgen Inc has made a £50 million equity investment in Oxford Nanopore Technologies Ltd of the UK as part of its strategy of using genetic data to develop new medicines. Amgen’s subsidiary deCODE Genetics of Iceland currently uses Oxford Nanopore’s sequencing technologies to conduct genome research including the identification and validation of new drug targets.
Novartis has announced plans to expand its presence in the field of radiopharmaceuticals with the acquisition of Endocyte Inc, a US company with drug conjugation technology for developing targeted therapies with companion imaging agents. The deal is valued at $2.1 billion.
Novartis reported a 3% rise in net sales to $12.8 billion for the third quarter of 2018, but operating profit dropped by 18% to $1.9 billion following the company’s voluntary withdrawal from the market of a surgical stent for glaucoma patients after a post-marketing study showed damage to patients’ eyes five years after treatment.
The Roche group reported sales of CHF 42.1 billion ($42.5 billion) for the first nine months of 2018, up by 7% from a year earlier led by strong demand in the US for its cancer medicines and a new multiple sclerosis drug. The Switzerland-based company does not provide earnings figures for the third quarter.
Nevertheless it is forecasting a further increase in its dividend in Swiss francs for the year. In 2017, the company paid a dividend of CHF 8.30 per share.
A new gene therapy company that uses chemogenetics-based technology has been launched in the US with plans to develop a product aimed at managing chronic neuropathic pain. CODA Biotherapeutics Inc is based in South San Francisco, California and made its debut on 12 September with a $19 million in Series A financing.
Austria-based Themis Bioscience GmbH has entered into a licencing agreement with Max-Planck-Innovation GmbH, the technology transfer arm of the Max Planck Society of Germany, for exclusive rights to an oncolytic measles virus platform that could be used to develop new oncology drugs.
The technology was jointly developed by Eberhard-Karls-University Tübingen and the Max Planck Institute for Biochemistry. Financial terms of the agreement were not disclosed.
The European Medicines Agency has issued new guidance to industry on Brexit, warning that all products under review by the UK regulatory authority will need to be transferred to rapporteurs or co-rapporteurs from the other EU member states. The rapporteur is the leader of the scientific team that evaluates applications from companies for marketing authorisations. The activities of this team are supported by the EMA secretariat. Once outside the EU, the UK’s Medicines and Healthcare products Regulatory Agency will no longer be eligible to participate in these evaluations.
The US Food and Drug Administration approved Libtayo (cemiplimab-rwlc) on 28 September for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation. The approval is the FDA’s first authorisation of a drug specifically for an advanced form of this disease.