Clinical Intelligence

CardioCell adds Stony Brook University to sites conducting phase IIa trial

Thursday, March 12, 2015 12:31 PM

CardioCell, a Stemedica Cell Technologies subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, has expanded patient recruitment to Stony Brook University’s Heart Institute for its phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients currently is underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.

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Quest Diagnostics

One World Cannabis, Sheba Academic Medical Center ink trial agreement

Thursday, March 12, 2015 12:13 PM

OWC Pharmaceutical Research's wholly owned subsidiary One World Cannabis, an Israel-based company focused on medical cannabis treatment and medical cannabis regulatory affairs, has signed a collaboration agreement with Sheba Academic Medical Center, the largest hospital in Israel and in the Middle East.

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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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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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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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The CenterWatch Monthly, March 2015

Monday, March 2, 2015 08:00 AM

Novo Nordisk, Takeda, ServierCelgene among top sponsors

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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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Palatin launches web site in support of phase III program for female sexual dysfunction

Thursday, February 26, 2015 12:15 PM

Palatin Technologies, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, has launched a clinical trial web site (https://www.reconnectstudy.com) in support of its phase III reconnect study with bremelanotide for the treatment of female sexual dysfunction (FSD).

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Omeros's phase II OMS721 trial completes dosing, extended access for compassionate use

Thursday, February 26, 2015 10:45 AM

Omeros has completed dosing of the low-dose cohort of patients in its ongoing phase II clinical trial evaluating the efficacy and safety of OMS721, the lead human monoclonal antibody for its mannan-binding lectin-associated serine protease-2 (MASP-2) program, in treating thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.

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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

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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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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