LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.

LONDON – Just nine months on from announcing the close of its $6.9 million seed round, Dunad Therapeutics Ltd. has landed a potential $1.3 billion deal with Novartis AG to discover and develop orally available protein degradation drugs. The cash is, of course, backend-loaded, but Dunad is getting a handy $24 million up-front payment and equity investment, and will receive full funding for the research.

PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes.

PARIS – Mauna Kea Technologies SA reported the commercial launch of a new generation of its in vivo cellular imaging for diagnostics in gastroenterology. At the same time, the company is deploying its new needle-based and miniprobe-based multidisciplinary confocal laser endomicroscopy platform in the U.S., as well as in France, Germany and Italy.

Zap Surgical Systems Inc. is debuting its noninvasive brain tumor treatment to the European market through an agreement with Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC). The Boulogne-based center, which is part of the American Hospital of Paris, said it expects patients to access the treatment by Fall 2022.

DUBLIN – Novadip SA raised €19 million (US$22.1 million) in a first close of a series B round to progress its autologous bone regeneration therapy, NVD-003, on either side of the Atlantic. The company is also working on an allogeneic regenerative approach, which is still preclinical.

The EMA and the EU Heads of Medicines Agencies are launching a pilot project to support not-for-profit organizations and academia in the repurposing of an authorized drug for a new indication in an area of public health interest.

LONDON – Four decades of academic research at the University of California, San Francisco, is to be translated through to the clinic with funding from a €1 million (US$1.2 million) European Commission grant. The money, awarded to a Dutch/German consortium will fund the generation and optimization of antibodies designed to neutralize oxidized phospholipids that mediate inflammatory changes in a swathe of diseases. The consortium that won the Eurostars award is led by Oxitope Pharma BV.

To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.

LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.