After years of investing in a product for stroke that failed, and then relaunching its portfolio around anaesthesia, Paion AG now has its sights firmly set on the commercialisation of its lead product, remimazolam, in the US.
The Wellcome Trust, one of the largest sources of private medical investment in Europe, has appointed Jim Smith as its director of science, a role that puts him in charge of scientific investigations and oversight of the Trust’s scientific investment portfolio.
Pharming Group NV has reached an agreement to take back North American commercialisation rights for its recombinant therapy for hereditary angioedema (HAE), Ruconest, from Valeant Pharmaceuticals International Inc giving it a chance to build a dedicated US sales force.
Germany-based Affimed NV is turning its focus to prospective combination therapies for its bispecific antibody portfolio, highlighted by the start of a Phase 1b study in the US combining its lead product AFM13 with the Merck & Co Inc immunotherapy Keytruda (pembrolizumab).
Genmab A/S has announced a new licencing agreement around its bispecific antibody platform – this time with Gilead Sciences Inc to create and develop candidate therapies targeting HIV.
Autifony Therapeutics Ltd, which has a technology for modulating ion channels, has reported the failure of a Phase 2a trial in patients with age-related hearing loss. However a second therapy based on the same technology passed a Phase 1 study in schizophrenia.
GW Pharmaceuticals Plc expects to file a new drug application (NDA) with the Food and Drug Administration for its cannabinoid medicine Epidiolex in the first half of next year following positive Phase 3 data in both Dravet and Lennox-Gastaut syndromes.
With revenue and productivity substantially up from a year earlier, Evotec has raised its financial forecast for the year to show a more than doubling of operating profit. This would bring earnings before interest, tax, depreciation and amortisation (EBITDA) to more than €17.4 million compared with €8.7 million in 2015.
Adaptimmune Therapeutics Plc said it is ready to respond to the Food and Drug Administration’s partial hold on its proposed pivotal study of a T cell therapy for treating a rare cancer of connective tissue called myxoid round cell liposarcoma.
A Phase 3 trial of a drug being developed by AstraZeneca Plc for patients with a specific mutation in lung cancer has failed to meet its primary endpoint of progression free survival, the company announced on 9 August. The drug, selumetinib, is a MEK 1/2 inhibitor.