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).
The US Food and Drug Administration has approved the first artificial heart valve for use in patients with a damaged valve and who are not eligible for open-heart surgery. The device is manufactured by Edwards Lifesciences LLC in the US.
The US Food and Drug Administration has approved a new medical device that gives patients with small arteries the option of less invasive surgery to repair abdominal aortic aneurysms. The device is manufactured by TriVascular Inc of California.
Transgene SA said it expects to start recruiting patients in December for a Phase 2b study of its cancer vaccine, TG4010, in patients with advanced non-small cell lung cancer. This follows regulatory approvals in the UK and France with further approvals expected soon.
Bavarian Nordic A/S has announced receipt of a $25 million milestone payment from the US government in connection with the scaling up of production of its smallpox vaccine, Imvamune, for delivery to the US national strategic stockpile.