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.
Shire Plc has reported a 24% increase in revenue to $1,086 in the third quarter from a year earlier while operating income was up by 15% to $341 million on the basis of an accounting measure that excludes non-recurring items. This is a non GAAP measure.
UCB SA of Belgium has revised upward its 2011 revenue forecast following the solid performance of its core pharmaceuticals in the first nine months of the year and weaker than expected competition for the off-patent anti-epileptic, Keppra (levetiracetam).
MorphoSys AG said it is maintaining its guidance for an operating profit of €10 million to €13 million in 2011 despite a widening of its third-quarter operating loss. On 30 September, the company had cash of €143 million compared with €108.4 million on 31 December 2010.
Clavis Pharma ASA said that a new retrospective study has provided the evidence it needs to establish which patients are likely to benefit from treatment with its experimental compound for pancreatic cancer, CP-4126.
Ipsen SA expects that sales of drugs to specialist physicians will rise by about 8% in 2011 following an increase of nearly 6% in the first nine months of the year. The company expects to report an operating income for the year of between €190 and €200 million.