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Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

Oraya Therapeutics, Inc., announced today that enrollment is now underway for the first ever masked and sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration (AMD).

6 Jan 2010

ARYx Therapeutics receives guidance in writing from FDA on tecarfarin

ARYx Therapeutics, Inc., a biopharmaceutical company, today announced that is has received guidance in writing from the U.S. Food and Drug Administration (FDA) confirming that the existing development pathway remains acceptable to seek regulatory approval of ARYx’s novel anticoagulant agent, tecarfarin (ATI-5923).

5 Jan 2010

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

VBL Therapeutics today announced the initiation of a Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. VB-201 is poised to be a first-in-class, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.

5 Jan 2010

Highlights of January 2010 'Ophthalmology'

This month's Ophthalmology, the journal of the American Academy of Ophthalmology, includes a research review of the effects of Vitamins C and E and magnesium on diabetic retinopathy and findings from the first large study of vision problems in Hispanic and African-American infants and young children.

5 Jan 2010

Significant opportunity for alternative ulcerative colitis biological therapy

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a biological therapy with a mechanism of action other than tumor necrosis factor alpha (TNF-alpha) inhibition for the treatment of moderate to severe ulcerative colitis, would earn a 25 percent patient share according to surveyed U.S. gastroenterologists. Similarly, in Europe, such an agent would also earn 25 percent patient share according to surveyed European gastroenterologists.

5 Jan 2010

Anti-inflammatory prescription drug reduces the risk of common skin cancer in humans

A widely-available anti-inflammatory prescription drug can reduce the risk of a common skin cancer in humans, according to a researcher at Stanford's School of Medicine.

5 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

Talampanel slows progression of amyotrophic lateral sclerosis

A drug already used to treat symptoms of epilepsy has potential to slow the muscle weakening that comes with amyotrophic lateral sclerosis (ALS), scientists report after completing a Phase II clinical trial-an early, small-scale test to show if the drug works and continues to be safe.

5 Jan 2010

Positive results from Pearl Therapeutics' PT005 Phase 2a trial for COPD

Pearl Therapeutics Inc., a company developing high-quality combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from its first clinical trial in patients with chronic obstructive pulmonary disease (COPD).

5 Jan 2010

BioInvent International begins BI-505 drug study on patients with advanced multiple myeloma

BioInvent International AB announced today that the first patient has been treated in an open, dose-escalation phase I study of the company’s antibody BI-505 for patients with advanced multiple myeloma.

4 Jan 2010

D-Pharm commences enrollment in MACSI Phase III clinical study for acute ischemic stroke

D-Pharm Ltd announced enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI). The first patient has been enrolled at the Wolfson Medical Center, Israel. The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm's most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).

3 Jan 2010

MEPREP to fund research to study the effects of medication in pregnant women

A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy.

31 Dec 2009

Santarus submits rifamycin SV MMX IND to the FDA

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea.

30 Dec 2009

Significant limitations in new Ginkgo biloba study published in JAMA, says ABC

New research findings published this week on a standardized Ginkgo biloba extract are very limited and the public should focus on the well-documented cognitive and cardiovascular benefits of ginkgo, said the American Botanical Council (ABC), an independent nonprofit research and education organization.

30 Dec 2009

Ginkgo biloba does not slow rate of cognitive decline in older adults

Older adults who used the herbal supplement Ginkgo biloba for several years did not have a slower rate of cognitive decline compared to adults who received placebo, according to a study in the December 23/30 issue of JAMA.

30 Dec 2009

Projects investigating placebo effects in Parkinson's disease receive funds

The Michael J. Fox Foundation for Parkinson's Research announced funding for two projects investigating the placebo effect in Parkinson's disease.

30 Dec 2009

Phase 3 trial of figitumumab discontinued by Pfizer

Pfizer Inc. announced today the discontinuation of A4021016 (also known as ADVIGO 1016), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer (NSCLC) due to the study meeting predefined boundaries for early termination.

30 Dec 2009

AspenBio Pharma reports on Premarket Notification submission plans for its ELISA format AppyScore test

AspenBio Pharma, Inc., an emerging bio-science company dedicated to the development of novel diagnostics and drugs for humans and animals, reported on its progress and plans for the Premarket Notification 510(k) submission of its ELISA format AppyScore™ test. AppyScore is the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis.

29 Dec 2009

SVA submits the first clinical trial application for HFMD vaccine in China

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China.

28 Dec 2009

PHT comments on FDA's PRO Final Guidance

PHT Corporation, the leading provider of ePRO (electronic patient reported outcome) solutions used in more than 400 clinical trials worldwide, commented on the FDA’s recent release of a final guidance almost four years following a Draft Guidance on the topic. The Final Guidance is entitled: Guidance for Industry, Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims.

24 Dec 2009