Theorem Clinical Research

United States

Blueprint Medicines, Alexion Pharmaceuticals ink $265M deal

Wednesday, March 4, 2015 12:55 PM

Blueprint Medicines is collaborating with Alexion Pharmaceuticals to discover, develop and commercialize novel drug candidates for an undisclosed activated kinase target, which is the cause of a rare genetic disease.

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Quest Diagnostics

Akili collaborates with Autism Speaks affiliate DELSIA

Monday, March 2, 2015 03:11 PM

Boston-based Akili Interactive Labs, developing clinically-validated video games for cognitive assessment and personalized treatment, has entered into a clinical collaboration agreement with Delivering Scientific Innovation for Autism (DELSIA).

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Dicerna Pharmaceuticals moves to Cambridge, Mass., will add 10 jobs

Friday, February 27, 2015 02:30 PM

Dicerna Pharmaceuticals, a developer of RNAi therapeutics, has opened a new 37,000-square-foot office and R&D laboratory in the Alewife area of Cambridge, Mass.

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Pearl IRB granted AAHRPP accreditation

Thursday, February 26, 2015 03:32 PM

Pearl IRB, an Indianapolis-based provider of central IRB review services, has received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

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Recursion Pharmaceuticals wins $1.5M NIH grant for rare diseases

Thursday, February 26, 2015 03:28 PM

Recursion Pharmaceuticals, an emerging biotech company founded in 2013 based on technology developed at the University of Utah, has been awarded $1.46 million from the NIH via the National Center for Accelerating Translational Sciences (NCATS). Just over half of the award is available in the first year; the rest will come through in year two pending availability of funds and project progress. The award will support the further development of Recursion’s Drug Screening Platform for hundreds of rare genetic diseases.

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FDA approves new antibacterial drug Avycaz

Thursday, February 26, 2015 01:12 PM

The FDA has approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

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Baxter selects northern Illinois site for Baxalta global headquarters

Wednesday, February 25, 2015 11:25 AM

Baxalta, the biopharmaceutical company expected to separate from Baxter International in mid-year, will be headquartered in northern Illinois. A long-term lease agreement for an approximately 260,000-square-foot facility extends for more than a decade.

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MedImmune, NIST partner to advance development of biological therapies

Monday, February 23, 2015 01:06 PM

MedImmune, the global biologics R&D arm of AstraZeneca, and the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) have signed a five-year agreement to jointly support research that will help advance drug discovery and manufacturing. The effort will focus on tools and measurements that will be used in the development and production of biopharmaceuticals, which are drugs and treatments derived from biological, rather than chemical, sources.

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Crohn's & Colitis Foundation, UNC expand IBD patient-focused engagement

Friday, February 20, 2015 12:29 PM

The Crohn's & Colitis Foundation of America (CCFA) is collaborating with the University of North Carolina School of Medicine (UNC) to create a research partnership between patients with inflammatory bowel disease (IBD) and the scientific community. CCFA Partners is a "patient-powered research network" for Crohn's disease and ulcerative colitis (collectively known as IBD) that uses state-of-the-art bioinformatics to engage and gather information from patients that researchers can study and analyze along with clinical and other patient-generated data.

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Collegium Pharmaceutical files NDA with FDA for Xtampza ER

Thursday, February 19, 2015 01:15 PM

The FDA has accepted for filing Collegium Pharmaceutical’s NDA for Xtampza ER, its novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain. Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development and commercialization of innovative abuse-deterrent treatments for chronic pain and other diseases

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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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