Clinuvel Pharmaceuticals Ltd. plans to complete a European regulatory filing for its lead drug Scenesse (afamelanotide) in the coming weeks, following a Phase III trial in patients with erythropoietic protoporphyria (EPP), which met its primary endpoint.
LONDON – NeuroSearch A/S is spinning out two start-ups to take forward programs that were parked in September when the company announced it was restructuring and would be focusing all resources on its Phase III Huntington's disease product, Huntexil.
LONDON – Oxford BioMedica plc can now boast three years' safety data and a sustained improvement in symptoms in all 15 patients treated in the Phase I/II trial of its ProSavin gene therapy for Parkinson's disease, but needs to progress to a higher dose "to provide more certainty" that this is not just a placebo effect, and to be competitive against deep brain stimulation treatment.
• Apeiron Biologics AG, of Vienna, Australia, said GlaxoSmithKline plc, of London, exclusive, worldwide licensee for Apeiron's new investigational recombinant human Angiotensin Converting Enzyme 2 (GSK2586881, formerly APN01), has initiated a Phase IIa study in patients suffering from acute lung injury.
As crunch time looms for TopoTarget A/S's lead pipeline molecule belinostat, which is undergoing a pivotal Phase II trial in 129 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), the company is cutting almost 40 percent of its Danish workforce in order to conserve cash and focus its resources.
• Beactica AB, of Uppsala, Sweden, inked an agreement with Almac Discovery Ltd., of Craigavon, Northern Ireland, for the use of its drug discovery platform, Sprint, to identify high-quality fragment hits against undisclosed targets of therapeutic interest to Almac. Beactica specializes in surface plasmon resonance biosensor-based small-molecule interaction analysis and partnerships for fragment-based lead generation using the Sprint platform.
LONDON – Closing the year with some cheer for the sector, Tissue Regenix Group plc has raised £25 million (US$39 million) in a placing, enabling the regenerative medicine specialist to begin to advance several programs in parallel.
LONDON – The health care sector in Europe has joined forces to push for industry involvement in the health technology assessments (HTA) that are increasingly being carried out to measure the added-value of new therapies, and then used as the basis of deciding whether or not to pay for them.
LONDON – A potent and rapid new method for analyzing the function of any mammalian gene is set to revolutionize the study of genetics. For the first time, scientists have managed to produce and grow mammalian embryonic stem cells containing only half the normal complement of chromosomes – a goal that researchers have striven to achieve for decades.
Molecular Partners AG entered a strategic alliance with Janssen Biotech Inc., under which it will team up with the Johnson & Johnson subsidiary to develop a broad pipeline of drugs, based on its Darpin scaffold technology, for a range of immunology indications.