Merck Serono has changed course and decided to continue development of its MUC1 antigen-specific immunotherapy against non-small lung cancer focusing on a patient subgroup. The Phase 3 trial is being conducted under a Special Protocol Assessment with the FDA.
Drisapersen, an antisense oligonucleotide being developed by GlaxoSmithKline Plc for Duchenne muscular dystrophy (DMD), has failed to meet its primary endpoint in a Phase 3 study – intended to lead to registration in the US.
Trials of potential treatments for both early and late-onset Alzheimer’s diseases are among seven projects to receive $45 million in new funding from the National Institutes of Health as part of a US effort to accelerate research into the disease.
Affimed Therapeutics AG has announced plans to advance a bispecific antibody into a Phase 2 trial in patients with Hodgkin lymphoma with co-funding from the US Leukemia & Lymphoma Society. The society will invest up to $4.4 million over two years in the project.
The Food and Drug Administration has granted ‘breakthrough therapy’ designation to the Genmab A/S-developed therapeutic antibody ofatumumab and to Boehringer Ingelheim’s (BI) kinase inhibitor volasertib for indications in oncology.
Sanofi SA has taken the unusual step of withdrawing its new drug application (NDA) for the Type 2 diabetes drug, lixisenatide, from the US Food and Drug Administration in order to allow a cardiovascular outcomes study of the drug to finish. The French company said the decision is not related to any safety issues or deficiencies with the application.
AstraZeneca Plc has moved to further strengthen its position in ovarian cancer with an agreement to in-license a kinase inhibitor from Merck & Co Inc that is currently being evaluated as a combination therapy in patients with certain types of the disease.
Kiadis Pharma BV of the Netherlands has disclosed five-year follow-up data for an allogeneic stem cell treatment for patients undergoing transplantations for leukaemia which showed a survival rate of 67% at the optimal dose. The data has been submitted to a peer-reviewed medical journal for publication.
Anergis SA of Switzerland said that a Phase 2b study of its lead vaccine for birch pollen allergy met the primary endpoint of reducing a symptom and medication score at the lower of two doses. Notably this was shown in a real-life, as opposed to a laboratory setting.
Prosensa Holding NV of the Netherlands has started a trial of its fourth antisense oligonucleotide drug for Duchenne muscular dystrophy (DMD), a genetic disorder that causes a progressive loss of muscle strength in patients.