LONDON – The Swiss headquarter operations of Arvelle Therapeutics GmbH are taking shape as the company awaits the outcome later this month of the FDA's deliberations on its in-licensed asset, cenobamate, and prepares to apply for EMA approval for the novel epilepsy treatment in the first half of 2020.
PARIS – Myriade SAS reported the commercial launch of its Videodrop technology at the second congress of the French Society of Extracellular Vesicles (FSEV) held in October in Nantes. This new nanoscale imaging technique captures all nanoparticles ranging from 30 nm to 10 μm in a droplet of solution (5-10μl volume), without initial data labeling.
LONDON – The U.K. government told the industry to maintain its readiness for a no-deal Brexit Tuesday, as it was forced to ask the EU for another extension after failing to get a revised withdrawal bill through Parliament.
LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).
LONDON – A U.K. national plan to upgrade population cancer screening will see greater adoption of genomics and biomarker-based testing, and the use of artificial intelligence to help interpret results. There will be moves to make it easier to pilot and adopt novel diagnostics and to do more targeted screening to identify and follow people who are shown to be at greater risk of developing specific types of cancer.
DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
DUBLIN – Sofinnova Partners closed its ninth early stage venture capital fund, Sofinnova Capital IX, at €333 million (US$369 million) and is bringing the same playbook to bear on current investment opportunities that it has followed in the recent past.
As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K.
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