Clinical Testing News and Research

RSS

Event addresses FDA's recent draft guidelines for development of biosimilar products

Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on the U.S. drug market in prepared testimony for the FDA's May 11th public hearing. The event addressed the FDA's recent draft guidelines for the development of biosimilar products.

14 May 2012

New system may help restore vision in eye diseases

Using tiny solar-panel-like cells surgically placed underneath the retina, scientists at the Stanford University School of Medicine have devised a system that may someday restore sight to people who have lost vision because of certain types of degenerative eye diseases.

14 May 2012

Rutin may inhibit formation of blood clots

A compound called rutin, commonly found in fruits and vegetables and sold over the counter as a dietary supplement, has been shown to inhibit the formation of blood clots in an animal model of thrombosis.

9 May 2012

Vascular Closure Systems completes FastSeal Phase I FIH clinical trial

The company is pleased to announce that after receiving Ethical Committee (EC) and Ministry of Health (MOH) approval, for the first human use of the company's FastSeal Bioabsorbable Vascular Access Closure System, Phase I of the First in Human (FIH) clinical testing has been completed, with 100% successful results, and no adverse effects, including post procedural discomfort.

9 May 2012

Galleon GAL-021 safe and well-tolerated in Phase I respiratory depression clinical study

Galleon Pharmaceuticals, a leader in the development of novel medicines to treat breathing disorders, today announced that its investigational drug GAL-021 appeared to be safe and well-tolerated and demonstrated dose-proportional pharmacokinetic effects on respiration in a Phase I clinical study of 30 healthy adults.

7 May 2012

Unigene first quarter net loss decreases to $6.0 million

Unigene Laboratories, Inc., today announced financial results for the first quarter ended March 31, 2012.

7 May 2012

Affymetrix total revenue decreases to $65.2 million

Affymetrix, Inc., today reported its operating results for the first quarter of 2012. Total revenue for the quarter was $65.2 million, as compared to total revenue of $73.7 million for the same period of 2011.

4 May 2012

Rigel first quarter net loss increases to $23.2 million

Rigel Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2012.

2 May 2012

Antibiotic effective for plague gets FDA nod

Federal regulators – The Food and Drugs Administration (FDA), have approved use of an antibiotic to treat plague, an extremely rare, sometimes-fatal bacterial infection.

30 Apr 2012

Researchers develop small endoscopic device fitted with femtosecond laser scalpel

Whether surgeons slice with a traditional scalpel or cut away with a surgical laser, most medical operations end up removing some healthy tissue, along with the bad. This means that for delicate areas like the brain, throat, and digestive tract, physicians and patients have to balance the benefits of treatment against possible collateral damage.

24 Apr 2012

Results from Presidio’s PPI-668 Phase 1a-1b trial on chronic HCV

Presidio Pharmaceuticals, Inc. announced results today from a Phase 1a-1b clinical trial of PPI-668, a potent, pan-genotypic HCV NS5A inhibitor being developed for the treatment of patients with chronic hepatitis C.

19 Apr 2012

ImmunoGen commences IMGN529 Phase I trial in NHL

ImmunoGen, Inc., a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN529 product candidate.

17 Apr 2012

Genocea to highlight progress in malaria vaccine development at World Vaccine Congress

Genocea Biosciences today announced that it will highlight new progress it is making toward the development of an effective vaccine for malaria during a presentation today at the World Vaccine Congress by Jessica Baker Flechtner, Ph.D., Vice President of Research.

12 Apr 2012

FDA clears Cerecor’s FP01 IND for treatment of cough

Cerecor Inc., a biopharmaceutical company focused on the discovery, development and commercialization of prescription pharmaceuticals whose primary activity is in the human nervous system, today announced that its Investigational New Drug (IND) Application for FP01 for the treatment of cough has cleared the 30 day deliberation period by the U.S. Food and Drug Administration.

12 Apr 2012

Bimodal genes can define molecular subtypes of ovarian cancer

Scientists from Duke University Medical Center have determined that genes acting as molecular "on/off" switches can define clinically relevant molecular subtypes of ovarian cancer, providing ideal potential targets for use in clinical prognostic and diagnostic testing.

9 Apr 2012

NINDS awards NeuroSigma Phase I grant to develop TFN-covered stents

NeuroSigma, Inc., a Los Angeles-based medical device company, today announced it has been awarded a Phase I NIH-STTR grant from the National Institute of Neurological Disorders and Stroke (NINDS) for the further development of its Thin-Film Nitinol (TFN)-covered stent for the potential treatment of brain aneurysms.

9 Apr 2012

BIND presents results from BIND-014 Phase 1 trial on solid tumors at AACR 2012

BIND Biosciences, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted therapeutics called Accurins, announced today the presentation of late-breaker clinical data for BIND-014, the lead drug candidate within a new class of targeted therapeutics that are programmed to concentrate at tumors, at the American Association for Cancer Research (AACR) 2012 Annual Meeting.

5 Apr 2012

Many medical implants never tested for safety

A new investigation by Consumer Reports reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market.

29 Mar 2012

MESO-1 device can help in diagnosis and treatment of cancer

A new device designed to more effectively produce DNA samples for genetic testing from slide-mounted tissue samples is better equipped than most models on the market to help in the diagnosis and treatment of cancer.

29 Mar 2012

DIAN-TTU to receive $4.2M Alzheimer's Association research grant

The Alzheimer's Association announced today the awarding of its largest ever research grant – nearly $4.2 million dollars over four years – to the Dominantly Inherited Alzheimer's Network–Therapeutic Trials Unit (DIAN-TTU), based at Washington University School of Medicine in St. Louis, to enable the program to move forward more quickly with innovative drug and biomarker trials in people with genetically-based, young-onset Alzheimer's disease.

21 Mar 2012