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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

Raptor Pharmaceutical completes $7.5 million registered direct offering

Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced that on December 22, 2009, it completed its registered direct offering with institutional investors, raising an aggregate amount of approximately $7.5 million of gross proceeds (before placement agent fees and offering expenses) through the sale of 3,747,558 units.

24 Dec 2009

AstraZeneca signs definitive agreement to acquire Novexel

Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial drug resistance, announces today that its shareholders have signed a definitive agreement whereby Novexel shall be acquired by AstraZeneca for a total cash consideration of up to $505 million, including contingent payments and the net cash position of the company at closing.

24 Dec 2009

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. announced today Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration.

24 Dec 2009

Synta Pharmaceuticals initiates STA-9090 Phase 2 clinical trial for GIST

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it is initiating a Phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST). This is the sixth clinical study of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.

23 Dec 2009

Achievements in lupus research, education and advocacy cause for celebration and hope

The year 2009 will be remembered as a year of many firsts for lupus, including the first successful phase III clinical trial of a potential new treatment for lupus, the launch of the first-ever Ad Council public awareness campaign for lupus, and the first comprehensive report on the barriers to lupus drug development. And it appears there are no signs of any slowing of momentum as we enter the New Year.

23 Dec 2009

Volcano lauds revised guidelines for treating severe coronary artery disease patients

Volcano Corporation, a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, reacted positively to the new guidelines for treating coronary disease and heart attacks using percutaneous coronary intervention (PCI), a procedure that treats narrowed blood vessels.

23 Dec 2009

National MS Society calls for grant applications to examine the impact of CCSVI hypothesis

2009 saw exciting research progress, unprecedented opportunities on the horizon, and more scientists than ever working on resolving important questions. Despite the year's economic and financial challenges, the National Multiple Sclerosis Society continues to propel research forward to end MS. In 2009 the Society provided over $33.5 million to support 345 new and ongoing projects in its research portfolio, plus $1.5 million for Fast Forward, the Society's drug development subsidiary which continues to attract new funding streams.

23 Dec 2009

Autism study and gene therapy in vision are top scientific achievements in 2009

A landmark autism study and a dramatic success for gene therapy in reversing inherited blindness, both at The Children's Hospital of Philadelphia, were recognized among the top scientific achievements in 2009, according to three national publications: Time magazine, Discover magazine and the journal Science.

23 Dec 2009

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

ARCA biopharma, Inc. today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.

23 Dec 2009

Clinical Trial News and Research

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

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

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

Santarus submits rifamycin SV MMX IND to the FDA

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

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

Projects investigating placebo effects in Parkinson's disease receive funds

Phase 3 trial of figitumumab discontinued by Pfizer

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

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

PHT comments on FDA's PRO Final Guidance

Raptor Pharmaceutical completes $7.5 million registered direct offering

AstraZeneca signs definitive agreement to acquire Novexel

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Synta Pharmaceuticals initiates STA-9090 Phase 2 clinical trial for GIST

Achievements in lupus research, education and advocacy cause for celebration and hope

Volcano lauds revised guidelines for treating severe coronary artery disease patients

National MS Society calls for grant applications to examine the impact of CCSVI hypothesis

Autism study and gene therapy in vision are top scientific achievements in 2009

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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