A prospective drug for Alzheimer’s disease that failed to show efficacy in late 2017 based on a Bayesian analysis of patient data, has now demonstrated its promise using more conventional statistical methods, according to Eisai Co Ltd and Biogen Inc.
The drug, BAN2401, is a monoclonal antibody targeting beta-amyloid, protein fragments in the brain which are thought to contribute to the neurodegenerative process in Alzheimer’s disease.
A consortium of predominately European investors is providing €47 million to Dynacure SAS of France to bring its candidate antisense oligonucleotide drug into the clinic for the treatment of patients with centronuclear myopathies.
Centronuclear myopathies are genetic disorders characterised by muscle weakness and wasting in the skeletal muscles. Dynacure’s lead product, Dyn101, is intended to treat these disorders by targeting dynamin 2, a protein that is implicated in cell processes such and cell motility and endocytosis.
Ipsen SA received further validation of its in-licensed compound cabozantinib following the publication in the 5 July edition of the New England Journal of Medicine (NEJM) of Phase 3 data showing the drug’s effectiveness in advanced liver cancer. Cabozantinib, which trades commercially as Cabometyx, has already been approved in the US and Europe for advanced kidney cancer. The drug was developed by Exelixis Inc and out-licensed to Ipsen in 2016 for commercialisation outside the US, Canada and Japan. Ipsen later acquired rights to Canada.
Deborah Dunsire, an experienced pharmaceutical company chief executive, is set to become CEO of H. Lundbeck A/S on 1 September. Trained as a medical doctor, Dr Dunsire has managed both biotech and pharmaceutical companies in the fields of oncology and central nervous system disorders. Her most recent position is as CEO of the oncology company XTuit Pharmaceuticals Inc. She has also been CEO of FORUM Pharmaceuticals Inc and of Millennium Pharmaceuticals Inc, now part of Takeda Pharmaceutical Co Ltd.
A candidate vaccine to prevent infection from the chikungunya virus has been accepted into the European Medicines Agency’s PRIME scheme, a programme of regulatory support for developers of medicines that meet a major public health need.
The vaccine is a biologic developed by Themis Bioscience GmbH of Austria and is currently undergoing Phase 2 studies in 600 patients across the US, the EU and South and Central America. The company hopes to receive marketing approval within three years.
Valneva SE is poised to bring its prophylactic vaccine for Lyme disease into a Phase 2 clinical study by the end of 2018 following positive discussions with the US Food and Drug Administration, the company announced on 2 July. The agency has given the product ‘fast track’ status in light of its potential contribution to public health.
Roche has reported positive results for a Phase 3 trial of its checkpoint antibody Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of patients with metastatic triple negative breast cancer. The trial showed a statistically significant improvement in progression-free survival.
The European Medicines Agency is recommending approval of caplacizumab, a new drug for treating the rare blood disorder, acquired thrombotic thrombocytopenic purpura (aTTP). The disorder leads to extensive micro-clot formation in the small blood vessels and potential damage to vital organs.
The European Medicines Agency has given positive opinions for two chimeric antigen receptor (CAR) T cell therapies to treat blood cancers – bringing these medicines closer to the market for patients in the EU.
Novartis is proposing to spin off its Alcon division into a separately listed eye care devices company leaving it to focus on pharmaceutical discovery and development. The transaction will be put to shareholders for a vote in February 2019 and if approved, would be completed by 30 June of that year.