Theorem Clinical Research

Novartis

Mallinckrodt appoints new leaders following completion of Questcor acquisition

Thursday, August 28, 2014 02:07 PM

Mallinckrodt, an Ireland-based global specialty pharmaceutical company, has announced that Gary Phillips, M.D., current senior vice president and chief strategy officer, has been appointed senior vice president and president of the company’s autoimmune and rare disease business, which includes the commercial organization supporting H.P. Acthar Gel.

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Novartis provides drug candidate compounds to TB Alliance

Thursday, August 21, 2014 01:48 PM

Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance), which has locations in the U.S., Brussels and South Africa, for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).

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Pfizer, Gamida Cell ink investment and option agreement

Wednesday, August 20, 2014 01:31 PM

Gamida Cell, an Israel-based provider of stem cell expansion technologies and therapeutic products, has signed an investment and option agreement with Novartis Pharma. Novartis will invest $35 million in Gamida Cell and in return will receive 15% equity and an option to fully acquire Gamida Cell. The option is exercisable for a limited period of time following achievement of certain milestones connected to the development of NiCord, anticipated to be met during 2015.

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Group of 19 institutional investors seeks support for biosimilars from top biopharma companies

Thursday, August 14, 2014 02:34 PM

Don’t bad mouth biosimilars—they are needed to help hold down skyrocketing drug costs.

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Pfizer, Roche join ADDPLAN DF Consortium

Monday, August 4, 2014 02:12 PM

Pfizer and Roche have joined the ADDPLAN DF Consortium. The consortium was founded in 2013 by Novartis, Janssen PharmaceuticalsEli Lilly and Aptiv Solutions, an Icon company, to lead the design and implementation of adaptive trials. The goal of the ADDPLAN DF Consortium is to develop methodologies and execution technologies that improve dose-selection, which remains a major barrier to resolving high failure rates in phase III trials.

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ABPI establishes Inward Investor Group

Wednesday, July 23, 2014 10:45 AM

The Association of the British Pharmaceutical Industry (ABPI) has established a new Inward Investor Group to demonstrate the importance of inward investment to the U.K. and the global mobility of such investment. The group also will work toward cultivating a favorable environment for pharmaceutical companies to invest in the U.K.

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Banner Alzheimer's Institute, Novartis partner

Wednesday, July 16, 2014 01:21 PM

Researchers from the Banner Alzheimer's Institute (BAI) have partnered with Novartis in a pioneering medical trial to determine whether two investigational anti-amyloid drugs—an active immunotherapy and an oral medication—can prevent or delay the emergence of symptoms of Alzheimer's in people at particularly high risk for developing the disease at older ages.

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Covance adds two to clinical development services leadership team

Monday, July 14, 2014 01:04 PM

Covance has announced two key additions to its clinical development services scientific leadership team with the appointments of Robert Wasserman, M.D., as vice president and global therapeutic area head, oncology, and Rogelio Mosqueda-Garcia, M.D., Ph.D., as global vice president, early clinical services within medical and scientific affairs. Both are based in Princeton, N.J.

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Bellerophon Therapeutics names Jonathan Peacock chairman and CEO

Wednesday, July 2, 2014 11:37 AM

Bellerophon Therapeutics, a clinical stage biotherapeutics company, has announced that Jonathan Peacock has been appointed chairman and CEO. Peacock assumes the role from Daniel Tasse, chairman and CEO of Ikaria, who was interim chairman and CEO of Bellerophon since the company's spin-out from Ikaria in February. Tasse will continue as a member of the board of Bellerophon.

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Novartis, Ophthotech ink agreement for Fovista

Wednesday, May 21, 2014 01:30 PM

Ophthotech, a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the eye, has entered into an ex-U.S. licensing and commercialization agreement with Novartis Pharmaceuticals focused on the treatment of wet age-related macular degeneration (AMD). Ophthotech grants Novartis exclusive rights to commercialize Ophthotech's lead product candidate, Fovista, in markets outside the U.S. while Ophthotech retains sole rights to commercialize Fovista in the U.S.

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CWWeekly

September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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The CenterWatch Monthly

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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