Sanofi Pasteur submits supplemental application for A(H1N1) pandemic vaccine to U.S. FDA
- Details
- Category: Sanofi
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), has submitted to the U.S. Food and Drug Administration (FDA) a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine. Responding to recent recommendations by the FDA, the company's supplemental application requests the FDA's evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
Forest Laboratories and AstraZeneca to Co-Develop and Commercialize a Next Generation Anti-Infective
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- Category: Business
Forest Laboratories (NYSE:FRX) and AstraZeneca (NYSE:AZN) have entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the United States, Canada and Japan. Ceftaroline is Forest's late stage, next generation cephalosporin being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).
Studies Highlight Potential New Option in the Treatment of Bone Loss
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- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) has announced the publication of results from two pivotal Phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss.
Sandoz launches first generic version of Prograf® capsules
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- Category: Novartis
Sandoz has announced the introduction of tacrolimus capsules, a generic equivalent of Prograf®, in the US. Tacrolimus is an immunosuppressive treatment used to help prevent rejection of a kidney or liver transplant.
Abbott Partners With Beech-Nut to Provide New Parents with Nutrition Education and Support
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- Category: Abbott
Abbott (NYSE: ABT), the maker of Similac® Infant Formulas, has partnered with baby food maker Beech-Nut Nutrition to provide new parents with infant and toddler parenting tips, tools and offers through the companies Web sites.
Nycomed and Forest Laboratories to collaborate on US commercialisation of Daxas® in COPD
- Details
- Category: Nycomed
Nycomed and Forest Laboratories, Inc. (NYSE: FRX) announced that they have
entered into an exclusive development, manufacturing and commercialisation
agreement in the United States for Daxas® (roflumilast), a once-daily oral treatment
for patients suffering from symptomatic Chronic Obstructive Pulmonary Disease
(COPD).
Boehringer Ingelheim to commence Phase III study investigating the role of BIBW 2992 (Tovok)
- Details
- Category: Boehringer Ingelheim
Boehringer Ingelheim has announced at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer (WCLC), San Francisco, CA, the initiation of a Phase III clinical study of BIBW 2992 as first-line treatment in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. BIBW 2992 (planned brand name Tovok™) is the first orally-administered, irreversible dual inhibitor of EGFR and HER2,(1) to reach Phase III development in NSCLC.(2)
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