The European Commission has been overruled in a dispute over the authorisation of an orphan medicine, in a case that further clarifies the ‘well-established medical use’ criteria for approving new drugs for marketing in Europe.
Japanese researchers have shown that it is possible to create a vascularised and functional human liver from human induced pluripotent stem cells – a finding that has implications both for organ regeneration and the testing of new drugs for toxicity.
What do age-related hearing loss and schizophrenia have in common? Not much, on the face of it. However there is growing evidence that the two disorders may have a link through the dysfunction of certain ion channels in the central nervous system. Ion channels are membrane proteins that help convert chemical or mechanical messages into electrical signals in the cell.
Cardio3 BioSciences SA of Belgium said that its previously announced European initial public offering of shares has raised €23 million from investors in Belgium, France, the UK, the Netherlands, Scandinavia and the US.
Orexo AB of Sweden said that it has received US Food and Drug Administration approval for Zubsolv (buprenorphine/naloxone), a product to be used with counselling and psychosocial support to treat people suffering from opioid dependence.
Valneva, a company created from the merger of Intercell AG of Austria and Vivalis SA of France, has raised €40 million in a share placement in order to support future vaccine and antibody product development. The offer was oversubscribed.
A project to develop biomarker-guided personalised vaccines for patients with glioblastoma has received €6 million in European Union funding under the Framework 7 programme. Immatics Biotechnologies GmbH is the coordinator.
For several years now scientists have been using computer science and advanced chemistry to produce experimental protein therapeutics that they say incorporate the best features of the small molecule drug and the antibody therapeutic. Bicycle Therapeutics Ltd of the UK is an example of this approach with its technology for structurally modified peptides.
AstraZeneca Plc will invest up to $100 million over five years in its previously-announced collaboration the Karolinska Institutet in Sweden to create a new centre for research into cardiovascular and metabolic diseases.
Privately-held Immunocore Ltd of the UK has secured a licencing deal with Genentech (Roche) to discover and develop therapies against multiple of cancer targets. The deal is potentially valued at more than $320 million.