Clinical Intelligence

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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FDA grants Genentech’s cobimetinib Priority Review for melanoma

Thursday, February 19, 2015 01:00 PM

The FDA has accepted and granted Priority Review for Genentech’s, a member of the Roche Group, NDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by Aug. 11.

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NIH trial compares three drugs for diabetic macular edema

Thursday, February 19, 2015 12:49 PM

In an NIH-supported clinical trial comparing three drugs for diabetic macular edema (DME), Eylea (aflibercept) provided greater visual improvement, on average, than did Avastin (bevacizumab) or Lucentis (ranibizumab) when vision was 20/50 or worse at the start of the trial. However, the three drugs resulted in similar average improvement when starting vision was 20/40 to 20/32. Investigators found no major differences in the safety of the three drugs. The trial was funded by the National Eye Institute (NEI), part of the NIH.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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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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The CenterWatch Monthly

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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