Theorem Clinical Research

Clinical Intelligence

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).

More... »

Quest Diagnostics

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.

More... »


The CenterWatch Monthly, March 2015

Monday, March 2, 2015 08:00 AM

Novo Nordisk, Takeda, ServierCelgene among top sponsors

More... »

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.  

More... »

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).

More... »

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.

More... »

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

More... »

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.

More... »

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.

More... »

Apellis enters clinical testing in age-related macular degeneration program

Wednesday, February 11, 2015 03:36 PM

Apellis Pharmaceuticals has begun the phase I clinical trial of its drug compound APL-2 in patients suffering from age-related macular degeneration (AMD).

More... »

AiCure
CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

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

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

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

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs