Clinical Research

Pharming reports positive result for Ruconest

Country
Netherlands

Netherlands-based Pharming Group NV has achieved positive results for its protease inhibitor replacement therapy Ruconest for the prevention of hereditary angioedema (HAE), a rare disorder caused by a deficiency of the C1 esterase inhibitor protein.

More evidence for Tagrisso in lung cancer

Country
United Kingdom

AstraZeneca Plc has received further evidence that its new personalised medicine for lung cancer is effective in patients with a specific genetic mutation. New Phase 3 data show that Tagrisso (osimertinib) increased progression-free survival compared with chemotherapy.

Roche oncology drug fails in new indication

Country
Switzerland

A Phase 3 study of the Roche therapy Gazyva (obinutuzumab) in patients with previously untreated diffuse large B-cell lymphoma failed to meet its primary endpoint, even though two previous studies of the same drug in different blood cancers succeeded.

Mesoblast accelerates trial readout

Country
Australia

Mesoblast Ltd is to do an early interim analysis of a Phase 3 trial of its cell therapy for heart failure in order to take a strategic view of the programme’s future. The analysis will take place in the first quarter of 2017, the Australian company announced on 1 July.

FDA puts hold on Juno trial

Country
United States

The US Food and Drug Administration has put a clinical hold on a Phase 2 trial of a new immunotherapy developed by Juno Therapeutics Inc after two patients died in early July. A third patient had previously died at the end of May.

Ablynx reports positive trial result for vobarilizumab

Country
Belgium

Ablynx NV said that its experimental compound for rheumatoid arthritis, vobarilizumab, was very effective with less frequent administration than tocilizumab when tested as a monotherapy in patients with moderate to severe rheumatoid arthritis.

Cell therapy for heart failure misses endpoint

Country
Belgium

A pioneering cell therapy designed to treat patients with congestive heart failure did not meet its primary endpoint in a Phase 3 European trial. But the developer, Celyad SA, said a subgroup did show statistical significance.

New link between Alzheimer’s and diabetes?

Country
United Kingdom

Researchers from the University of Aberdeen have called attention to a possible new link between Alzheimer’s disease and diabetes in a study published in the journal Diabetologia. 

Circassia floored by trial failure

Country
United Kingdom

The share price of Circassia Pharmaceuticals Plc fell by 64.85% to 95 pence in mid-morning trading on 20 June following the announcement that its phase-3 trial of its cat allergy drug failed to meet its primary endpoint.

Human trials under scrutiny

Country
United Kingdom

The European Medicines Agency has launched a review of guidelines for the testing of new medicines in volunteers following the death of one person and the hospitalisation of five others in France in January. The case is the most serious incident to come to light since 2006 when an experimental immunotherapy seriously injured six volunteers in a first-in-human study the UK.