United States

Selten Pharma receives FDA Orphan Drug designation for PAH

Thursday, March 19, 2015 01:13 PM

Selten Pharma, a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, has announced its lead compound tacrolimus (SPI-026) has been granted Orphan Drug designation by the FDA for the treatment of pulmonary arterial hypertension (PAH).

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Tute Genomics, Google Genomics collaborate on genetic database

Thursday, March 19, 2015 12:03 PM

Tute Genomics, a Utah­-based provider of a clinical genome interpretation platform, along with Dr. Xiaoming Liu and his team at the University of Texas, have teamed up with Google to grant public access to a database of 8.5 billion annotations of genetic variants through Google Genomics.

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CRF Health launches eCOA solution for global diabetes trials

Wednesday, March 18, 2015 01:17 PM

CRF Health, a global provider of eCOA solutions for the life sciences industry headquartered in Plymouth Meeting, Pa., has launched a complete TrialMax eCOA solution for diabetes clinical trials. Developed with clinicians and patients to optimize usability and compliance, the solution enables investigators to collect patient reported outcome assessments and deliver defensible data, while minimizing patient and site burden. Already being used in four major global diabetes trials, covering 700 investigative sites and 3,250 patients, the solution offers complete integration between patient eDiary entry and blood glucose measurements.

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HealthCarePoint completes CDISC BlueCloud transnational commerce system

Monday, March 16, 2015 01:46 PM

HealthCarePoint (HCP), a Texas-based healthcare and clinical research networking-technology company, has completed development of the BlueCloud commerce system for the Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit charitable organization.

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XBiotech launches cancer patient directed web site and call center

Monday, March 16, 2015 09:00 AM

XBiotech, an Austin, Texas-based developer of next generation therapeutic antibodies, has launched a web site and call center to help patients with metastatic colorectal cancer learn about its U.S. pivotal phase III clinical trial. The phase III study, Xilonix Colorectal cancer Immunotherapy Treatment Evaluation (XCITE), assesses XBiotech's True Human monoclonal antibody (Xilonix) for the treatment of metastatic colon cancer.

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Report: U.S. prescription drug spending increased 13.1% in 2014

Thursday, March 12, 2015 12:56 PM

New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in U.S. drug spending in 2014—a rate not seen in more than a decade—according to new data released in the 2014 Express Scripts Drug Trend Report. Headquartered in St. Louis, Mo., Express Scripts provides integrated pharmacy-benefit management services.

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Epic Sciences, Prostate Cancer Clinical Trials Consortium collaborate

Monday, March 9, 2015 12:22 PM

Epic Sciences, a San Diego, Calif.-based developer of novel diagnostics to personalize and advance the treatment and management of cancer, and the Prostate Cancer Clinical Trials Consortium (PCCTC), a consortium for phase I/II and phase II clinical trials in prostate cancer, will collaborate to apply Epic's circulating tumor cell (CTC) technology in multiple investigator-initiated clinical trials to advance the development of new prostate cancer treatments.

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Targacept, Catalyst Biosciences ink merger

Monday, March 9, 2015 12:20 PM

Targacept, a biopharma company based in Winston-Salem, N.C., and Catalyst Biosciences, a privately held biopharma company based in South San Francisco, Calif., have agreed to merge. The combined entity, to be named Catalyst Biosciences, is expected to create a financially strong company to harness the catalytic power of engineered human proteases to develop next-generation biopharmaceuticals with improved efficacy and therapeutic index to treat major diseases.

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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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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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CWWeekly

July 6

FDA sued by advocacy groups seeking hepatitis C trials data

Google to test health-tracking wristband to collect clinical trial data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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