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.
Ablynx NV has reported positive efficacy results from a second Phase 2b study of its biologic vobarilizumab in patients with moderate to severe rheumatoid arthritis, showing a strong decline in disease symptoms at 24 weeks of treatment.
The Food and Drug Administration has approved a field trial of a mosquito that has been genetically modified in order to reduce the population of Aedes aegypti mosquitoes in the environment that carry the Zika virus.