The European Medicines Agency (EMEA) has been formally notified by Pfizer Limited of its decision to withdraw its application for a change to the marketing authorisation for the medicine Viagra (sildenafil) 50 mg film-coated tablets.

On 19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by the United States District Court for the District of New Jersey, halting sales of Teva's budesonide inhalation suspension product, a generic version of AstraZeneca's PULMICORT RESPULES treatment.

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced that Russia has chosen inactivated polio vaccine (IPV) from Sanofi Pasteur for primary immunization of all infants. The IPV doses are provided by M.P. Chumakov Institute of Poliomyelitis and Virus Encephalitides through a manufacturing agreement with Sanofi Pasteur.

Pfizer today announced the launch of a new research unit known as Pfizer Regenerative Medicine. This independent research unit will build on recent scientific progress in understanding the biology of stem cells and the opportunity that provides, to discover and develop a new generation of regenerative medicines for major medical needs.

AstraZeneca has announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure (MRP) for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment of major depressive episodes in bipolar disorder.

Roche has announced that the SATURN (SequentiAl Tarceva in UnResectable NSCLC) study met its primary endpoint of progression free survival. The study showed that Tarceva (erlotinib), when given in first line maintenance - immediately following initial treatment with platinum-based chemotherapy - , significantly extended the time patients with advanced non-small cell lung cancer (NSCLC) lived without their cancer getting worse.

Findings from the ATLAS ACS TIMI 46 study - a Phase II study of the novel oral anticoagulant Xarelto® (rivaroxaban) - were presented as a late-breaking clinical trial at the American Heart Association's Scientific Sessions 2008 in New Orleans by C. Michael Gibson, M.D., Director of the TIMI Data Coordinating Center, Harvard Medical School, Boston, Massachusetts, USA.