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.
TiGenix NV said that group revenues for the first nine months of 2011 were €1.1 million of which the majority was generated by the company’s cell-based therapy to treat knee injuries, ChondroCelect. Cash at 30 September 2011 was €20.5 million.
Sanofi produced considerably better results in the third quarter than its record for the first nine months, opening the possibility that loss of patent protection on certain drugs will be less of a drag on its accounts going into the future.
Oxford BioMedica Plc has entered into a research and development collaboration with the Mayo Clinic in the US to develop a gene therapy for the treatment of chronic glaucoma. It is the company’s second partnership in the area of eye disease.
GlaxoSmithKline Plc said it has reached an agreement in principle with the US government to pay $3 billion to settle civil and criminal investigations relating to sales and marketing practices, including those for Avandia (rosiglitazone).