The US Food and Drug Administration has approved the first C1 esterase inhibitor for the prophylaxis of hereditary angioedema, a rare protein deficiency that can cause swelling of the limbs or airway. The product, Haegarda, was developed by CSL Behring LLC.
As medical developers edge their way towards using biomarkers to establish progress in clinical trials, a British company has developed an epigenetic, blood-based marker with potentially broad applications for detecting disease.
Another step towards developing a cell therapy for retinal disease was reported by UK-based ReNeuron Group Plc on 19 June, following approval by the US Food and Drug Administration of its formulation for cryopreserving cells.
China’s Creat Group Corp, one of the country’s large investors in foreign companies, is purchasing Germany’s Biotest AG, a Frankfurt Stock Exchange-listed biologics company, for about €1.2 billion.
The coming into effect of new legislation governing the conduct of clinical trials in the EU has been delayed again due to difficulties with the development of the underlying IT system, the European Medicines Agency announced on 16 June.
Helsinn Healthcare SA has returned elsiglutide, a treatment for chemotherapy-induced diarrhoea, to its creator, Zealand Pharma A/S, thus ending a partnership agreement to develop the drug further.
Abzena Plc, which provides technology and services to pharmaceutical companies, reported an 89% increase in revenue to £18.7 million for its fiscal year ended 31 March 2017.
A UK medical charity has decided that royalty income from intellectual property that it licensed to the developers of Keytruda, should be reinvested in innovation. The charity, LifeArc, has therefore set up two new funds to support academic research and early-stage biotech companies.
It has been a little more than a year since Medicxi Ventures (UK) LLP was spun out of Index Ventures to provide capital to early life science in Europe. Now, the venture fund has expanded its reach with the launch of a new fund that will finance later stage assets.
Kiadis Pharma NV of the Netherlands has raised €5 million in new funds from a private placement of its shares which will help finance a Phase 3 study of its lead cell therapy for immune reconstitution, which was submitted for review by the European Medicines Agency on 26 April.