Clinical Trial News and Research

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Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

Patient enrollment for PLATINUM workhorse trial completed by Boston Scientific

Boston Scientific Corporation (NYSE: BSX) today announced the completion of patient enrollment in the workhorse portion of its PLATINUM clinical program. PLATINUM is a global, randomized, pivotal controlled trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the platinum chromium PROMUS((R)) Element(TM) Everolimus-Eluting Coronary Stent System.

19 Sep 2009

Pharmacyclics announces financial results for fourth quarter and FY 2009

Pharmacyclics, Inc. today reported financial results for its fourth quarter and fiscal year ended June 30, 2009. During the fourth quarter of fiscal 2009 Pharmacyclics incurred a GAAP net loss of $5.4 million, or $0.20 per share, compared to a net loss of $4.6 million, or $0.18 per share for the fourth quarter of fiscal 2008.

18 Sep 2009

New vaccine may prove effective against urinary tract infections

University of Michigan scientists have made an important step toward what could become the first effective vaccine to prevent urinary tract infections, if the robust immunity achieved in mice can be reproduced in humans.

18 Sep 2009

Eastern Europe, Latin America and Asia are new regions for clinical trials

Aon Corporation, the leading global provider of risk management services, insurance and reinsurance brokerage, and human capital consulting, today issued the findings of its 2009 Clinical Trials Risk Map to address the constantly changing environment in which biotechnology, pharmaceutical and medical device companies conduct business around the world.

18 Sep 2009

FDA approves Valturna tablets for treating high blood pressure

The US Food and Drug Administration (FDA) has approved Valturna((R)) (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure.

18 Sep 2009

Mayo Clinic scientists conduct clinical study on functional dyspesia patients

"Nerve cells are found throughout the body, and just as their dysfunction in the brain can cause depression, we suspect overly sensitive nerves in the gut can produce this very uncomfortable indigestion," says Nicholas Talley, M.D., Ph.D., chair of the trial and chair of the Department of Internal Medicine at the Mayo Clinic campus in Florida.

18 Sep 2009

HTDS update on its H1N1 project status

HTDS- The Company is pleased to provide the following update to its shareholders and followers on the (H1N1) Vaccine for Mellow Hope Inc, its China based subsidiary; and other general business matters.

18 Sep 2009

China SFDA approves clinical trial of China Aoxing's abuse resistant opioid drug

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that its Clinical Trial Application ("CTA") for Tilidine/Naloxone Capsules, an opioid drug with abuse resistance property, was officially approved by the China State Food and Drug Administration ("SFDA").

17 Sep 2009

Intarcia's ITCA 650 phase 2 study in type 2 diabetes begins patient enrollment

Intarcia Therapeutics, Inc. today announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide.

17 Sep 2009

Educational initiative proves successful in identifying and diagnosing fibromyalgia

According to The Johns Hopkins University School of Medicine, the Fibromyalgia Circle of Care Initiative has achieved dramatic success in heightening awareness, diagnosis and best practice treatment of fibromyalgia – a complex and chronic pain disorder that plagues an estimated 10 million Americans.

17 Sep 2009

Results from Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 announced

GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) today announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.

17 Sep 2009

New legislation protects healthcare coverage for rare disease clinical trial participants

Four members of the United States Senate introduced legislation today to allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare coverage, echoing a move by the House of Representatives last month.

17 Sep 2009

Bayer HealthCare to present its clinical trial data at a joint Multidisciplinary Congress

Bayer HealthCare today announced that data from more than 30 clinical trials evaluating three products in the company's oncology portfolio - Nexavar(R) (sorafenib) tablets, regorafenib (BAY 73-4506) and Alpharadin(TM) - will be presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20-24, 2009 in Berlin, Germany.

17 Sep 2009

Charley's Fund and the Nash Avery Foundation to support investigation of Galapagos' SARM candidate drug

Galapagos NV (Euronext: GLPG), Charley's Fund Inc. and the Nash Avery Foundation announced today that they will collaborate to investigate the potential effectiveness of Galapagos' SARM candidate drug, G100192, in treating Duchenne muscular dystrophy. G100192 is an orally-available small molecule therapeutic, which has demonstrated successful Proof of Concept in pre-clinical studies for cachexia (the loss of weight and muscle mass).

17 Sep 2009

Quest PharmaTech reports second quarter fiscal 2009 results

Quest PharmaTech Inc. (TSX-V: QPT) ("Quest" or the "Company"), a pharmaceutical company developing and commercializing products for the treatment of cancer and dermatological conditions, today announced fiscal second quarter results for the period ended July 31, 2009.

17 Sep 2009

DNage's observational study assesses natural progression of CS in children

Biotech company Pharming Group NV ("Pharming" or "the Company") announced today that its wholly-owned subsidiary DNage has initiated an observational study in children suffering from Cockayne Syndrome (CS).

17 Sep 2009

Clinical trial focuses on healing diabetic foot ulcers with stem cells

Fortis Healthcare, one of India's leading private hospital groups, has announced it will broaden inclusion criteria for its upcoming diabetic foot clinical trial. The study will use stem cells derived from peripheral blood to treat critical limb ischemia (diabetic foot).

17 Sep 2009

Bioheart's MARVEL Phase II/III clinical trial successful

Bioheart, Inc. (OTCBB:BHRT), presented positive efficacy data from part 1 of its Phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston, Massachusetts. Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University, presented the final data for Part 1 of the MARVEL Phase II/III Clinical Trial as a part of the Late Breaking Clinical Trials Session.

17 Sep 2009

FDA approves Sirion's Zirgan for treating acute herpetic keratitis

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007.

17 Sep 2009

Clinical Trial News and Research

Millennium's sNDA for VELCADE granted priority review by the FDA

Patient enrollment for PLATINUM workhorse trial completed by Boston Scientific

Pharmacyclics announces financial results for fourth quarter and FY 2009

New vaccine may prove effective against urinary tract infections

Eastern Europe, Latin America and Asia are new regions for clinical trials

FDA approves Valturna tablets for treating high blood pressure

Mayo Clinic scientists conduct clinical study on functional dyspesia patients

HTDS update on its H1N1 project status

China SFDA approves clinical trial of China Aoxing's abuse resistant opioid drug

Intarcia's ITCA 650 phase 2 study in type 2 diabetes begins patient enrollment

Educational initiative proves successful in identifying and diagnosing fibromyalgia

Results from Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 announced

New legislation protects healthcare coverage for rare disease clinical trial participants

Bayer HealthCare to present its clinical trial data at a joint Multidisciplinary Congress

Charley's Fund and the Nash Avery Foundation to support investigation of Galapagos' SARM candidate drug

Quest PharmaTech reports second quarter fiscal 2009 results

DNage's observational study assesses natural progression of CS in children

Clinical trial focuses on healing diabetic foot ulcers with stem cells

Bioheart's MARVEL Phase II/III clinical trial successful

FDA approves Sirion's Zirgan for treating acute herpetic keratitis

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