AstraZeneca

FDA approves EPANOVA for severe hypertriglyceridemia

Wednesday, May 7, 2014 02:43 PM

AstraZeneca has announced the FDA approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

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WIRB Copernicus Group

Pfizer pursues AstraZeneca for potential $100 billion acquisition deal

Monday, April 28, 2014 02:15 PM

Having rejected two bids since January, Pfizer made its next move on Monday—a $99 billion stock and cash offer to acquire AstraZeneca, to create a single U.K.-based company that would become the world’s largest pharmaceutical company.

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GSK, Novartis, Eli Lilly swap assets to specialize, become more profitable

Wednesday, April 23, 2014 08:42 AM

In a major swap of assets, three of the world’s largest drug companies have announced a multi-part, $28.5 billion deal that enables Novartis to focus more on cancer, GlaxoSmithKline on vaccines and Eli Lilly on animal health.

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U.S. cancer researchers launching five-drug personalized medicines trial

Monday, April 21, 2014 01:12 PM

U.S. cancer researchers plan to launch a five-drug clinical trial for patients with advanced lung cancer in mid-May, in a public-private collaboration between several major cancer organizations and five pharmaceutical companies that marks the second American multi-drug research program into personalized medicines to treat different cancers.

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Cancer Research U.K. to launch 14-drug, personalized medicine trial

Friday, April 18, 2014 01:57 PM

British researchers, working with two global pharmaceutical companies, are planning to launch a different kind of personalized medicine clinical trial that could change how cancer drugs are studied and potentially cut the time and cost of bringing them to market.

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Icon’s Firecrest training recognized by TransCelerate BioPharma

Monday, April 14, 2014 10:13 AM

Icon,a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that its Firecrest training meets TransCelerate BioPharma’s minimum criteria for International Conference on Harmonization Good Clinical Practice (ICH/GCP) training.

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CEO Roundtable on Cancer launches data-sharing initiative to accelerate drug development

Thursday, April 10, 2014 01:03 PM

The CEO Roundtable on Cancer has launched Project Data Sphere, a new online oncology data-sharing platform using de-identified cancer patient information with the goal of accelerating drug discovery—by developing more efficient clinical trial protocols, epidemiological studies and, ultimately, new cancer therapies. 

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Glythera makes appointments to support company expansion

Thursday, April 3, 2014 11:26 AM

Glythera, a biotechnology company specializing in the development of next generation bio-therapeutics, including Antibody Drug Conjugates,  through the application of its proprietary linker and stable glycan technologies PermaLink and PermaCarb, has appointed of Nigel Burns as non-executive director and Ian Evetts as commercial director. Glythera has recently validated data from their core technologies and the addition of Burns and Evetts coincides with the company’s expansion plan exploring new opportunities to provide essential support during the company’s growth plan.

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AstraZeneca, Shenzhen University Health Science Center to collaborate

Monday, March 31, 2014 01:37 PM

AstraZeneca has announced a research collaboration with Shenzhen University Health Science Center. The partners will undertake preclinical research focused on chronic kidney disease (CKD), which represents a large and growing unmet medical need in China.

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AstraZeneca completes purchase of Sumitomo Chemical’s stake in AstraZeneca K.K.

Wednesday, March 26, 2014 11:40 AM

AstraZeneca has completed the purchase of Sumitomo Chemical’s remaining shares in AstraZeneca K.K. The purchase was valued at approximately $102 million and gives AstraZeneca control of the entire shareholding of AstraZeneca K.K.

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CWWeekly

July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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