A study of patients with chronic obstructive pulmonary disease (COPD) who were treated with a new GlaxoSmithKline Plc medicine compared with the standard of care, has shown a benefit for the new medicine in everyday clinical practice.
The European Medicines Agency is recommending a tightening of its guideline on first-in-human clinical trials to provide better protections for volunteers and a new approach to evaluating protocols that cover a number of different study parts.
A review of patients who had experienced a stroke and were treated with an experimental stem cell therapy has shown the therapy to be safe and linked to improved neurological function. Data from a two-year follow-up of the patients were published in The Lancet on 20 August.
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.
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).
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.
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 Bristol-Myers Squibb Company’s checkpoint antibody Opdivo (nivolumab) hit a roadblock on 5 August when a Phase 3 study failed to meet its primary endpoint in patients with previously untreated non-small cell lung cancer.