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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

Researchers mix active drug and placebo to maximize drug benefits for efficient treatment

Researchers used the placebo effect to successfully treat psoriasis patients with one quarter to one half of their usual dose of a widely used steroid medication, according to an early study published online today in the journal Psychosomatic Medicine.

23 Dec 2009

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Resverlogix Corp. ("Resverlogix" or the "Company") announced today that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).

23 Dec 2009

Viron Therapeutics' three drug candidates granted U.S. patents

Viron Therapeutics Inc., a biotechnology company pioneering the development of virally-derived protein therapeutics, today announced that it has been granted U.S. patents related to three of its drug candidates, VT-111, VT-346 and VT-384.

23 Dec 2009

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Arena Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients.

22 Dec 2009

Health Canada approves Prevnar 13 vaccine for invasive pneumococcal disease

Following a Priority Review, Health Canada has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)) for children aged six weeks through five years for active immunization against invasive pneumococcal disease, a bacterial infection that can include meningitis (inflammation of the coverings of the brain and spinal cord), sepsis (bloodstream infection), bacteremic pneumonia, pleural empyema (accumulation of pus in the cavity surrounding the lungs) and bacteremia (bacteria in the blood).

22 Dec 2009

Cell Medica receives second grant for development of adenovirus infection therapy

Cell Medica, a clinical stage cellular therapeutics company engaged in the development and delivery of cellular immunotherapy treatment strategies for infectious disease and cancer, has announced that is has appointed four key staff to drive forwards the Company’s activities in the commercialisation of cell therapy treatments.

22 Dec 2009

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

CSL Limited, Australia’s leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 ‘swine’ flu vaccine.

22 Dec 2009

Advisory Panel of independent ENT experts recommends FDA to approve Envoy Medical's Esteem

Envoy Medical, a Minnesota corporation, has developed the first Fully Implantable Hearing Restoration System known as the Esteem®. On December 18th, an Advisory Panel of independent ENT experts unanimously recommended that the FDA approve the Esteem®.

22 Dec 2009

LEO Pharma announces positive results for two Phase III AK clinical trials

LEO Pharma today announced positive results for the company’s two Phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) Gel for the treatment of lesions on head treatment areas, which include the face and scalp.

22 Dec 2009

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Neurocrine Biosciences, Inc. today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

21 Dec 2009

Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

Idera Pharmaceuticals, Inc. today announced positive interim results from a Phase 1 clinical trial of IMO-2125 in patients with chronic hepatitis C virus infection (HCV). IMO-2125 is an agonist of Toll-like Receptor 9 that Idera designed to treat HCV by inducing endogenous interferon-alpha and other Th1-type cytokines and chemokines.

21 Dec 2009

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today that they have entered into a global license and collaboration agreement to develop and commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Organogenesis, Inc. announced today that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its CelTx(TM), a living cellular construct for oral soft tissue regeneration. If approved, CelTx will be the first, living cell-based technology that is FDA-approved for use in the dental market.

21 Dec 2009

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

21 Dec 2009

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis.

21 Dec 2009

EMEA grants orphan drug designation for pixantrone in Europe

Cell Therapeutics, Inc. ("CTI") announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma.

21 Dec 2009

Only half of eligible heart failure patients receive implantable devices

A study of heart failure patients who meet national guidelines for devices that stabilize and strengthen the heart's electrical system found that only half of eligible patients received the devices.

19 Dec 2009

John Theurer Cancer Center presents over 20 research updates and trial results at the 2009 ASH meeting

Doctors and researchers from the John Theurer Cancer Center at Hackensack University Medical Center recently presented research updates and clinical trial results of more than 20 innovative studies at the American Society of Hematology (ASH) annual meeting from December 5-8, 2009.

18 Dec 2009

Clinical Trial News and Research

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

Researchers mix active drug and placebo to maximize drug benefits for efficient treatment

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Viron Therapeutics' three drug candidates granted U.S. patents

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Health Canada approves Prevnar 13 vaccine for invasive pneumococcal disease

Cell Medica receives second grant for development of adenovirus infection therapy

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

Advisory Panel of independent ENT experts recommends FDA to approve Envoy Medical's Esteem

LEO Pharma announces positive results for two Phase III AK clinical trials

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

EMEA grants orphan drug designation for pixantrone in Europe

Only half of eligible heart failure patients receive implantable devices

John Theurer Cancer Center presents over 20 research updates and trial results at the 2009 ASH meeting

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