Theorem Clinical Research


FDA approves first biosimilar Zarxio from Sandoz

Friday, March 6, 2015 12:24 PM

Sandoz, a Novartis company, has became the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilar pathway established under the Biologics Price Competition and Innovation Act.

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Quest Diagnostics

Array BioPharma purchases phase III assets from Novartis

Wednesday, March 4, 2015 01:07 PM

Array BioPharma has completed both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85 million from Novartis.

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GSK, Novartis complete major three-part transaction

Monday, March 2, 2015 03:03 PM

GlaxoSmithKline and Novartis have completed their three-part transaction. As a result, GSK has acquired Novartis' global vaccines business (excluding influenza vaccines) for $5.25 billion and has divested its oncology business to Novartis for $16 billion. In addition, the two have created a new consumer healthcare joint venture in which GSK will have majority control and an equity interest of 63.5%.

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Adimab, Sanofi collaborate on bispecific antibodies

Monday, February 9, 2015 12:20 PM

Adimab, a Lebanon, N.H.-based technology company focused on the discovery of fully human antibodies and bispecifics, has announced a multi-target discovery and optimization collaboration with Sanofi. Adimab will use its proprietary platform to generate bispecific molecules against multiple targets. Sanofi will have the right to develop and commercialize all therapeutic antibodies and bispecifics resulting from the collaboration.

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Regulatory update on GSK-Novartis three-part transaction

Thursday, January 29, 2015 12:25 PM

GlaxoSmithKline has received clearance from the European Commission (E.C.) of its proposed three-part transaction with Novartis, which includes the acquisition of Novartis’s vaccines business (excluding influenza vaccines), the creation of a consumer healthcare joint venture between GSK and Novartis and the divestment to Novartis of GSK’s marketed oncology portfolio, related R&D activities and rights to two pipeline AKT inhibitors.

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Array to acquire Novartis BRAF inhibitor encorafenib (LGX818)

Friday, January 23, 2015 11:40 AM

Array BioPharma, based in Boulder, Colo., has reached a definitive agreement with Novartis Pharma to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.

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FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

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Optum Labs adds five collaborators

Thursday, January 15, 2015 01:37 PM

Optum Labs, a Cambridge, Mass.-based collaborative research and innovation center co-founded by Optum and Mayo Clinic, has added five new collaborators committed to improving the quality and value of patient care. These include:

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Qualcomm, Novartis collaborate to optimize global clinical trials

Wednesday, January 7, 2015 12:56 PM

Qualcomm Life, a San Diego, Calif.-based provider of device connectivity and data management for the medical device industry, has been selected by Novartis as a global digital health collaborator for its Trials of The Future program.

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Intellia Therapeutics, Novartis partner

Wednesday, January 7, 2015 12:40 PM

Intellia Therapeutics, a Cambridge, Mass.-based developer of therapeutic products using CRISPR/Cas9 technology for gene editing and repair, has announced a five-year R&D collaboration with Novartis to accelerate the ex vivo development of new CRISPR/Cas9-based therapies using chimeric antigen receptor T cells (CARTs) and hematopoetic stem cells (HSCs).

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March 30

Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

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The CenterWatch Monthly


Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly


Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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