Areas of focus for research sites in 2017

Monday, January 30, 2017

The Pulse on Site Success by Christophe Berthoux

As 2016 came to a close, many of us spent time reflecting and forecasting for the next year. The clinical research industry has continued to experience significant change and 2016 was no exception. We explored many topics, most notably patient-centricity, methods aimed at streamlining processes and proactive ways to handle study startup. These themes will continue to remain industry discussion topics and new site models will set trends moving forward.

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Dr. Andreas Rummelt joins supervisory board of Leukocare

Tuesday, July 19, 2016

Leukocare, a provider of stabilizing and protecting formulation technologies for biopharmaceuticals like biologics and vaccines, announced the election of Dr. Andreas Rummelt as new member of its supervisory board. Together with Dr. Jean-Paul Prieels, who held various executive positions at GlaxoSmithKline, former Sandoz CEO Dr. Rummelt is the second former executive from big pharma on the Leukocare board. 

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Novartis cuts pharmaceutical division in half

Friday, May 20, 2016

Novartis has announced changes to focus its Pharmaceuticals Division by creating two business units reporting to the CEO: Novartis Pharmaceuticals and Novartis Oncology. These business units will form the Innovative Medicines Division at Novartis. The leader of each business will join the Executive Committee of Novartis (ECN) effective July 1, 2016. Paul Hudson will be appointed CEO, Novartis Pharmaceuticals, and Bruno Strigini will become CEO, Novartis Oncology. Both will report directly to Joseph Jimenez, CEO of Novartis. With these changes, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis. 

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Pfizer to acquire Anacor for $5.2B

Monday, May 16, 2016

Pfizer and Anacor Pharmaceuticals have entered into a definitive merger agreement under which Pfizer will acquire Anacor for $99.25 per Anacor share, in cash, for a total transaction value, net of cash, of approximately $5.2 billion, which assumes the conversion of Anacor’s outstanding convertible notes. The Boards of Directors of both companies have unanimously approved the transaction. Anacor’s flagship asset, crisaborole, a differentiated non-steroidal topical PDE4 inhibitor with anti-inflammatory properties, is currently under review by the FDA for the treatment of mild-to-moderate atopic dermatitis, commonly referred to as eczema.

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FDA accepts Sandoz submission for proposed biosimilar

Monday, October 5, 2015

The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.

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