News

New Merck Serono spin-out to focus on AD

Country
Switzerland

Merck Serono SA has announced the creation of a third spin-out company – this time focused on therapies for Alzheimer’s disease and tau protein-related pathologies. This follows its parent company’s decision to downsize and to close the Geneva office.

Ablynx secures ion channel deal with Merck & Co

Country
Belgium

Ablynx is set to receive €6.5 million upfront under a new collaboration with Merck & Co to develop and commercialise candidate antibody therapeutics that target a voltage gated ion channel, with an option to develop an antibody against a second target.

FDA approves new indication for Humira

Country
United States

The US Food and Drug Administration has approved a new indication for Humira (adalimumab) to include the treatment of moderate-to-severe ulcerative colitis in adults. It is the seventh US approval for the drug which is marketed by Abbott Laboratories.

FDA approves Stivarga for colorectal cancer

Country
United States

The US Food and Drug Administration has approved Stivarga (regorafenib), a multi-kinase inhibitor, to treat patients with metastatic colorectal cancer. Developed by Bayer AG, the drug was approved under the agency’s priority review procedure.

UCB reports on olokizumab in RA

Country
Belgium

UCB SA said that a Phase 2b study of its candidate antibody for rheumatoid arthritis, olokizumab, met its primary endpoint. But there was no improvement in efficacy when the drug was compared with tocilizumab (Actemra).

Sobi reports on haemophilia trial

Country
Sweden

Swedish Orphan Biovitrum (Sobi) has told analysts that its recombinant clotting factor product for haemophilia B achieved positive results in a Phase 3 trial, paving the way for a regulatory filing in the US in the first half of 2013.

Noxxon to test drug in multiple myeloma

Country
Germany

Noxxon Pharma AG of Germany has started a Phase 2a study of an oligonucleotide-based drug in patients with multiple myeloma, a disease that accounts for about 1% of all cancers. The 28-patient, multi-center study is being conducted in Europe.

FDA to support new antibiotic development

Country
United States

The US Food and Drug Administration has said it will review its regulatory guidelines and consult experts on clinical trial design in a renewed push to stimulate the development of new antibiotic drugs – a public health priority.

Epigenomics changes management team

Country
Germany

The chief financial officer of Epigenomics AG is to double up as acting chief executive as the company moves to shore up its share price and prepare for a regulatory submission of its lead diagnostic. CFO Thomas Taapken will assume the two jobs on 1 October.