FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Roche to receive FDA approval for people with advanced cancers within the past two years.
Abbott to collaborate with Janssen and Pharmacyclics
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- Category: Abbott
Abbott (NYSE: ABT) announced that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.
New findings from two studies support substantial benefit of Pradaxa®
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- Category: Boehringer Ingelheim
Today, the New England Journal of Medicine published findings from the RE-MEDYTM and RE-SONATETM trials investigating Pradaxa® (dabigatran etexilate) in the long-term prevention of deep vein thrombosis (DVT) or pulmonary embolism (PE). The results demonstrate that Pradaxa® 150 mg twice daily is an effective option with a favourable safety profile for the extended prevention of recurrence of these venous blood clots (known as venous thromboembolism or VTE) after a first event.*
UCB announces regulatory filings for Cimzia® (certolizumab pegol)
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- Category: UCB
UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia® (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).
Sanofi New Drug Application for lixisenatide accepted for review by FDA
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- Category: Sanofi
Sanofi (EURONEXT : SAN and NYSE : SNY) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.
ViiV Healthcare announces FDA priority review designation for dolutegravir
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- Category: GlaxoSmithKline
ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents.
Accelerating focus on the patient
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- Category: UCB
With its "crossover year" delivered in 2012 and UCB's new core medicines now driving company growth, UCB's transformation into a biopharma company is complete. UCB is now entering an important new phase of revenue growth with no major patent expiry expected until the end of the decade.
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- Roche delivers strong 2012 results
- AstraZeneca fourth quarter and full year results 2012
- GSK response to news article in The Guardian on UK legal proceedings related to Avandia
- Bristol-Myers Squibb reports fourth quarter financial results