US FDA accepts regulatory submission for acalabrutinib and grants Priority Review
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- Category: AstraZeneca
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor.
Roche reports strong performance in the first half of 2017
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- Category: Roche
In the first half of 2017, Group sales rose 5% to CHF 26.3 billion. Core EPS grew 6%, ahead of sales. Core EPS growth reflects the strong underlying business performance. IFRS net income increased 2%. Sales in the Pharmaceuticals Division increased 5% to CHF 20.5 billion. The recently launched medicines Tecentriq, Ocrevus and Alecensa contributed CHF 0.5 billion of new sales, which represents half of the division's growth.
Bristol-Myers Squibb and Clovis Oncology announce a broad clinical collaboration
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) and Clovis Oncology, Inc. (Nasdaq:CLVS) announced the companies have entered into a clinical collaboration agreement to evaluate the combination of Bristol-Myers Squibb's immunotherapy Opdivo and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca in pivotal phase 3 clinical trials in:
AstraZeneca and Merck establish strategic oncology collaboration
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- Category: AstraZeneca
AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca's Lynparza (olaparib) for multiple cancer types.
Johnson & Johnson announces encouraging first-in-human clinical data for investigational HIV preventive vaccine
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- Category: Johnson & Johnson
Johnson & Johnson has announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017),
Sandoz expands partnership with World Child Cancer, to help children access treatment in four developing countries
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- Category: Novartis
Sandoz today announces the expansion of a pilot project with leading charity World Child Cancer, aimed at improving access to treatment and optimizing survival outcomes for children suffering from cancer in four developing countries. The agreement builds on an existing partnership with World Child Cancer in the Philippines, where Sandoz is funding staff training needs and helping children to access diagnosis and subsequent treatment.
Pfizer announces positive top-line results from the comparative REFLECTIONS B7391003 study for PF-06439535, a potential biosimilar to Avastin® (bevacizumab)
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) has announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin®(1) (bevacizumab), met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin.
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