Theorem Clinical Research

Articles Published in 2015

FDA expands approved use of Opdivo to treat lung cancer

Thursday, March 5, 2015 01:42 PM

The FDA has expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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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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AbbVie to acquire Pharmacyclics for $21B, boosting hematological oncology franchise

Thursday, March 5, 2015 12:38 PM

AbbVie has announced a definitive agreement to acquire Pharmacyclics and its flagship asset Imbruvica (ibrutinib), a treatment for hematologic malignancies. 

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Altasciences, ITR Laboratories form alliance

Thursday, March 5, 2015 12:36 PM

Altasciences, a Canada-based provider of early phase clinical research services, and ITR Laboratories, a nonclinical CRO, have formed a strategic alliance to offer clients a way to customize their drug development programs from lead candidate selection through to early stage clinical trials. This alliance facilitates working with a single integrated partner to bring drug candidates to proof-of-concept faster and reduce costs.

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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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Baxter International acquires SuppreMol

Thursday, March 5, 2015 12:35 PM

Baxter International has acquired SuppreMol for approximately $225 million. SuppreMol is a privately held biopharmaceutical company based in Martinsried, Germany, developing treatment options for autoimmune and allergic diseases.

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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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Techorizon launches electronic tool for feasibility study performance

Thursday, March 5, 2015 12:31 PM

Techorizon, a technology company based in Verona, Italy, with North American offices in Cambridge, Mass., has launched FeRMI, an electronic application for the conduct of clinical trial feasibility studies. Techorizon also launched a new web site.

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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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VolitionRx initiates second prostate cancer study assessing nucleosomics technology

Thursday, March 5, 2015 12:23 PM

VolitionRx, a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has initiated a pilot study to assess the feasibility of VolitionRx's proprietary NuQ assays in detecting prostate cancer. The study is in collaboration with ImmuneHealth, a global biomarker CRO, and is taking place in Belgium.

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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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