PRADAXA® first drug in 50 years to gain approval for stroke prevention in atrial fibrillation
The European Commission (EC) approved Boehringer Ingelheim's breakthrough oral anticoagulant, Pradaxa® (1) (dabigatran etexilate (2) ) for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke. This EU label extension means that, for the first time in over 50 years, millions of AF patients across Europe will have access to a new treatment for the prevention of AF-related strokes which is effective and convenient (3,4,) and has demonstrated a good safety profile. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission has approved the use of RoACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (medicines used to treat inflammation). RoACTEMRA (known as ACTEMRA outside Europe) can be given alone or in combination with methotrexate in patients with sJIA. 
AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway. AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers. 
Sales of the Bayer Group grew by 0.8 percent in the second quarter to EUR 9,252 million (Q2 2010: EUR 9,179 million). The currency- and portfolio-adjusted (Fx & portfolio adj.) increase was 5.4 percent. Business performance in the emerging markets made an above-average contribution to this development. The operating result (EBIT) advanced by a substantial 25.9 percent to EUR 1,273 million (Q2 2010: EUR 1,011 million). 
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.