Merck Serono is set to pay Ablynx NV €20 million upfront as part of a new agreement to co-discover and co-develop antibody-derived therapeutic proteins against two targets in osteoarthritis. This is an expansion of an existing partnership.
The Committee for Advanced Therapies (CAT) was set up at the European Medicines Agency in 2009 in order to give expert advice on whether advanced therapy medicinal products should be approved or not. These therapies include gene and cell therapies and products engineered from human and/or animal tissue.
The first of four Phase 3 trials which are investigating a new compound as an adjunct therapy to antidepressants has failed to meet its primary endpoint, according to AstraZeneca Plc and Targacept Inc, the sponsors.
Intercell AG, the Austrian vaccine developer, reported higher revenue for the third quarter and the first nine months of 2011 and a sharply lower operating loss following a restructuring programme that involved setting new priorities for research and development.
The US Food and Drug Administration has approved Erbitux (cetuximab) for use with chemotherapy to treat patients with metastatic head and neck cancer. The drug is already approved to treat epidermal growth factor receptor-positive colon cancer.
Evolva Holding SA said it has received regulatory clearance to start a Phase 2a study in Germany of a compound to treat the complications of diabetes. The compound, EV-077, is thought to have potential as a treatment for vascular events in diabetics.
CureVac GmbH has reported data from an early clinical trial of a second cancer vaccine that is based on messenger RNA (mRNA). The study showed that 65% of patients with non-small cell lung cancer responded to at least one of five antigens.
Ablynx NV is taking back rights to two programmes for antibody-derived therapeutic proteins from Pfizer Inc following the US company’s decision to drop the products from its portfolio. Ablynx’s shares dropped by about 18% on the day.
Sanofi SA has filed five new products with regulatory authorities in the US and/or in the European Union since late July including a new glucagon-like peptide-1 agonist for type 2 diabetes, lixisenatide, developed by Zealand Pharma A/S of Denmark.
Transgene SA of France and Jennerex Inc of the US have announced the start of a Phase 2b study of a vaccine for patients with advanced liver cancer who have failed prior treatment with sorafenib, the only approved drug for the disease.