The notoriously tight-fisted National Institute for Health and Care Excellence (NICE), which makes healthcare product payment decisions for the U.K. on what can be used in the country's National Health Service (NHS), has come out with a recommendation in support of the use of the MiniMed Paradigm Veo system from Medtronic. It's specifically for adults and children with Type 1 diabetes who have had disabling episodes of hypoglycemia even with continuous subcutaneous insulin infusion.
In a sign of the continuing headwinds for biotech, Shield Therapeutics has had to cut both its price and its original aims to see through its U.K. IPO.
In this week's EuroBiotech Report, the results from a Phase I trial of Heptares' muscarinic M1 receptor agonist have added to its belief that its pursuit of an Alzheimer's disease target that stumped Eli Lilly can pay off. And more.
AstraZeneca has kicked off another clinical trial of monalizumab, bringing to an end a rollout of studies it committed to when it struck its $1.3 billion (€1.1 billion) alliance with Innate Pharma. The fifth and final clinical trial in the first wave of studies is investigating the combination of monalizumab and AstraZeneca's big immuno-oncology hope durvalumab.
4D pharma has struck a deal to buy Tucana Health. The takeover, which is costing £3.1 million ($4.5 million) upfront with more tied to milestones, is intended to boost 4D pharma's ability to identify patients who may benefit from live biotherapeutics, starting with a treatment for irritable bowel syndrome.
Regulators in Spain are punishing a Barcelona-based drugmaker for a series of manufacturing shortfalls, recalling all batches produced by the company, Farma Mediterrania, from 2014 to present. The crackdown is the second in as many months by Spanish authorities on local producers.
Catalent's plant in Beinheim, France, offline for four months because of suspected sabotage to products, is expected to be fully up and running next month. It is a good thing for the Somerset, NJ-based company since its suspension of the soft-gel capsule plant shaved $21 million off its top line in the last quarter and led it to lower its forecast for the year.
Ferring Pharmaceuticals is set to put its prostate cancer drug Firmagon up against AbbVie's Lupron in a Phase IIIb trial. The study is designed to assess the cardiovascular safety profile of the gonadotropin-releasing hormone receptor agonist and antagonist, potentially giving Ferring an edge over a product that generated $826 million (€744 million) for AbbVie last year.
ImmuPharma has raised £8.3 million ($12.0 million) to propel its lupus drug through a Phase III study. The cash will support ImmuPharma through to the data readout from its 200-person transatlantic trial, at which point management will weigh up commercialization options.
Hemovent has raised a $6 million Series A financing to support the development of what it expects will be the world's smallest and first self-contained and fully portable Extra Corporeal Membrane Oxygenation (ECMO) system to support or replace heart and lung function.