Theorem Clinical Research

Global News

Eisai, Merck collaborate on combination regimens for cancer

Thursday, March 5, 2015 12:29 PM

Eisai and Merck, through a subsidiary, have formed a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (marketed in the U.S. under the brand name Keytruda), in combination with Eisai oncology compounds lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the U.S. under the brand name Lenvima, lenvatinib) and eribulin mesylate (a microtubule dynamics inhibitor marketed in nearly 60 countries including Japan, the U.S. and Europe under the brand name Halaven, eribulin) in multiple clinical trials.

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Quest Diagnostics

AMRI hires VP of International Sales

Thursday, March 5, 2015 11:14 AM

Albany Molecular Research (AMRI), a global CRO based in Albany, N.Y., has hired Michael Pettersson to fill the newly created position of vice president of International Sales, effective immediately. He reports to Christopher Conway, senior vice president of Global Sales and Marketing.

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Malin to acquire Serenus Biotherapeutics

Wednesday, March 4, 2015 01:22 PM

Serenus Biotherapeutics, a San Francisco, Calif.-based specialty biopharmaceutical company, has secured investment of up to $43 million from Malin, an Ireland-based global life sciences company focused on healthcare.

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Domain Therapeutics launches Kaldi Pharma

Wednesday, March 4, 2015 01:21 PM

Domain Therapeutics, a France-based biopharmaceutical company specializing in the research and early development of new drug candidates targeting G protein-coupled receptors (GPCRs), has created a Specific Purpose Vehicle (SPV), Kaldi Pharma, for the exclusive development of its A2a/A1 and A2a antagonist programs.

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Exostar, DocuSign partner

Wednesday, March 4, 2015 01:19 PM

DocuSign, a San Francisco- and Seattle-based company that provides electronic signature technology and Digital Transaction Management (DTM) services, and Herndon, Va.-based Exostar, an information technology company offering cloud-based solutions enabling secure business-to-business collaboration, will partner to allow life sciences and healthcare organizations to automate manual, paper-based processes with faster, more secure and fully-compliant all-digital document workflows.

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Sun Pharma to buy GSK’s Opiates business in Australia

Wednesday, March 4, 2015 01:16 PM

GlaxoSmithKline has reached an agreement with India-based Sun Pharma to sell GSK’s opiates business in Australia, including related manufacturing sites in Latrobe (Tasmania) and Port Fairy (Victoria) and its portfolio of opiates products along with inventory, to a subsidiary of Sun Pharma.

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AtheroNova and subsidiary file for Ch. 11 bankruptcy protection

Wednesday, March 4, 2015 01:16 PM

AtheroNova and its subsidiary, AtheroNova Operations, filed voluntary petitions under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court, Central District of California, Santa Ana division on March 2. The company's Chapter 11 cases are expected to be jointly administered.

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Denovo Biopharma licenses late-stage neuroscience drug from Eli Lilly

Wednesday, March 4, 2015 01:15 PM

Denovo Biopharma, a privately held biotechnology company based in San Diego, has exclusively licensed Pomaglumetad Methionil (mGlu2/3 receptor agonist), a late-stage neuroscience drug, from Eli Lilly. Denovo gains all rights to develop, manufacture and commercialize pomaglumetad globally, including transfer of all intellectual property and other rights, data and information. Lilly has an option to re-acquire pomaglumetad upon a successful clinical trial, for predetermined undisclosed financial terms.

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Kite Pharma expands R&D collaboration with National Cancer Institute

Wednesday, March 4, 2015 01:11 PM

Kite Pharma, a clinical stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer based in Santa Monica, Calif., has amended its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

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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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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

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

February

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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