AstraZeneca Plc said that an outcomes study of its cardiovascular drug Brilinta (ticagrelor) has shown the treatment to be effective in preventing a recurrence of disease in patients with a history of heart attack. The trial examined the drug at two different doses with aspirin in 21,000 patients.
Shire Plc is to strengthen its rare-disease franchise with an agreement to acquire NPS Pharmaceuticals Inc of Bedminster, New Jersey for $5.2 billion. The transaction, announced on 11 January, has been approved by the boards of directors of both companies.
Cardio3 BioSciences SA has acquired a portfolio of immuno-oncology assets in the US thereby expanding its therapeutic focus to cancer in addition to cardiovascular medicine. The Belgium-based company specialises in regenerative medicine.
Merus BV has successfully fought off a patent infringement lawsuit brought against it in the US by Regeneron Pharmaceuticals Inc, thus securing freedom to operate in the space for transgenic-mouse based antibody therapeutics. The Dutch company announced the decision on 5 January 2015.
The US Food and Drug Administration has approved a new indication for the cystic fibrosis medicine Kalydeco (ivacaftor) which extends coverage to patients whose disease is caused by the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The Sweden-based biotechnology company Active Biotech AB has raised SEK 225 million (€24 million) in an oversubscribed rights issue to support development of its clinical-stage portfolio, the lead product of which is in a pivotal trial for multiple sclerosis.
The US Food and Drug Administration has approved Saxenda, a glucagon-like peptide-1 receptor agonist developed by Novo Nordisk A/S for the treatment of weight management in addition to a reduced-calorie diet and exercise.
Pieris AG, of Germany has achieved US funding of $13.56 million and a Nasdaq listing by entering into a reverse takeover.
The European Medicines Agency’s main scientific committee is recommending approval of a stem cell therapy to treat limbal stem cell deficiency. It is the first positive opinion for a stem cell therapy and the fifth for an advanced therapy medicinal product (ATMP).
Roche has halted a Phase 3 trial of the monoclonal antibody gantenerumab in prodromal Alzheimer’s disease patients based on a pre-planned futility analysis. No new safety signals were observed in the trial, which was called SCarletRoAD.