Theorem Clinical Research

United States

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

Asterias Biotherapeutics initiates trial for complete cervical spinal cord injury

Thursday, March 5, 2015 01:34 PM

Asterias Biotherapeutics, a biotechnology company in the emerging field of regenerative medicine, announced that Atlanta-based Shepherd Center, a rehabilitation hospital for spinal cord injury and brain injury, has commenced enrollment for the phase I/IIa clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).

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Mayo Clinic, Gentag to develop wireless sensors for treatment of obesity and diabetes

Thursday, March 5, 2015 12:35 PM

Mayo Clinic, a nonprofit organization based in Rochester, Minn., and Gentag, a wearable biosensor company based in Washington, D.C., have reached an agreement to develop the next generation of wearable biosensors designed to fight obesity and diabetes.

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FDA launches drug shortages mobile app

Thursday, March 5, 2015 12:34 PM

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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Johnson & Johnson Innovation opens JLABS @South San Francisco

Wednesday, March 4, 2015 01:30 PM

Johnson & Johnson Innovation has opened JLABS @South San Francisco (JLABS @SSF), a 30,000-square-foot incubator located in South San Francisco, Calif. The Johnson & Johnson Innovation, JLABS site can accommodate up to 50 startups from across the healthcare spectrum including biotech, pharmaceutical, medical device, consumer and digital health. 

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Cardinal Health to acquire Johnson & Johnson’s Cordis

Wednesday, March 4, 2015 01:18 PM

Johnson & Johnson has received a binding offer from Cardinal Health, a healthcare services company based in Dublin, Ohio, to acquire its Cordis business for an aggregate value of $1.99 billion, consisting of $1.944 billion of cash proceeds from Cardinal Health plus approximately $46 million of retained net receivables. Cordis is a developer and manufacturer of interventional vascular technology with 2014 net revenues of approximately $780 million.

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CCFA, University of Pennsylvania, Nestlé collaborate on IBD study

Wednesday, March 4, 2015 01:09 PM

The Crohn's & Colitis Foundation of America (CCFA) has entered into a research partnership with the Perelman School of Medicine at the University of Pennsylvania and Nestlé Health Science to study the effects of diet on gut bacteria. The study is part of a major CCFA effort to develop new treatments targeting the gut microbiome—the "ecosystem" of microbes populating the intestines—linked to the development of inflammatory bowel diseases (IBD).

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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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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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CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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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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