Drug Clinical Trials

Pharmacyclics Completes Trial Of Factor VIIa Inhibitor PCI-27483

ruzik_tuzik — Tue, 25 Nov 2008 22:25:38 -0600

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the company has completed a Phase 1 clinical trial with PCI-27483, the company's novel, first-in-class small-molecule Factor VIIa inhibitor. The trial was conducted in sixteen (16) healthy volunteers to evaluate the safety and pharmacologic effect of PCI-27483. A single administration of PCI-27483 resulted in a linear dose response in the International Normalized Ratio (INR), a routine laboratory test used to assess the level of anticoagulation (blood-thinning).

How Drugs Work In Patients With Complex Health Problems

ruzik_tuzik — Tue, 25 Nov 2008 12:27:33 -0600

The New York Times on Tuesday, in an occasional series called "The Evidence Gap," examined the "growing movement" among researchers to conduct "pragmatic," or "real world," clinical trials to gather evidence "that will fill some of the biggest gaps in medical science: What treatment is best for typical patients with complex symptoms?"

How Often Physicians Refer Minority Patients To Clinical Trials

ruzik_tuzik — Thu, 20 Nov 2008 11:08:57 -0600

"Factors Influencing Physician Referrals of Patients to Clinical Trials" (.pdf), Journal of the National Medical Association: The study, by University of South Carolina medical researchers, looks at physicians' attitudes and beliefs about recruiting patients to clinical trials, particularly minorities.

FDA gets tougher on the Pharma industry via DDMAC

hareyan — Wed, 19 Nov 2008 08:49:34 -0600

The hiring of 12 new reviewers for the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is allowing the agency to beef up its scrutiny of Pharma promotional materials. There has been a marked increase in the number of warning and untitled letters sent to manufacturers in the past few months.

The FDA said it has a greater capacity to review promotional pieces because of staffing increases, but the agency did not say a recent spate of regulatory letters was a direct result of taking on new staff.

Hope of speeding up drug development

hareyan — Wed, 19 Nov 2008 08:41:42 -0600

Almost every day brings news of an apparent breakthrough against cancer, infectious diseases, or metabolic conditions like diabetes, but these rarely translate into effective therapies or drugs, and even if they do clinical development usually takes well over a decade. One reason is that medical research is conducted in highly fragmented groups focusing on specific pathways or components leading to drugs that turn out not to work properly or to have dangerous side effects after cycles of animal and then clinical testing in humans.

Pharmaceutical Industry Has Big Problems

hareyan — Wed, 19 Nov 2008 08:23:12 -0600

Big pharma has big problems. The root cause is a lack of research and development productivity, which means a dearth of new products to make up for looming patent expirations. Something near half of big pharma’s revenues will be threatened by generic competition within the next three to four years, and that will radically change the face of the industry.

POT-4 For Age-Related Macular Degeneration Shows Positive Safety Profile

ruzik_tuzik — Wed, 12 Nov 2008 00:01:31 -0600

Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), presented Phase I data last week during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) Annual Meeting in Atlanta, GA. The data was from the ASaP (Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration) clinical trial for the company's leading drug candidate, POT-4, which is being developed for the treatment of AMD.

Clinical Trial Showed Reduced Inflammation In Cardiovascular Patients

ruzik_tuzik — Tue, 11 Nov 2008 01:55:50 -0600

Montreal Heart Institute Research Centre Director Dr. Jean-Claude Tardif presented yesterday results from a clinical trial demonstrating that VIA-2291, an investigational drug being developed by VIA Pharmaceuticals, Inc., significantly inhibited production of leukotrienes, proposed mediators of vascular inflammation, in patients with serious heart disease. VIA-2291 was well-tolerated with no serious adverse events attributed to the drug. The study was presented in a Special Session at the American Heart Association 2008 Scientific Sessions in New Orleans, Louisiana.

Trial Of Experimental Anti-Coagulant Reports Safety

ruzik_tuzik — Mon, 10 Nov 2008 10:17:52 -0600

Researchers reported on a study of a new oral anti-clotting agent — rivaroxaban — designed to identify doses that would be safe to test in subsequent Phase III efficacy and safety trials. The results of ATLAS ACS-TIMI 46 were presented as a late-breaking clinical trial at the American Heart Association’s Scientific Sessions 2008.

PEGASYS Regimen Provides Higher Sustained Virological Response Rates For Hepatitis C Patients

ruzik_tuzik — Mon, 03 Nov 2008 22:43:31 -0600

A new, independently-conducted study being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) shows that PEGASYS (peginterferon alfa-2a) treatment regimens result in higher sustained virological response (SVR) rates for hepatitis C patients as compared to regimens with another pegylated interferon.(1)

Comparing Today's Standard Treatment Regimens: The Milan Safety Tolerability Study