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Abbott announces results from HUMIRA clinical studies on ulcerative colitis

Abbott (NYSE: ABT) today announced results from an analysis of three-year long-term data from an ongoing open-label extension of the HUMIRA (adalimumab) ULTRA 1 and ULTRA 2 studies.

23 Oct 2012

Derma Sciences to initiate DSC127 Phase 3 program in diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers.

23 Oct 2012

Possible overlap exists between inflammatory bowel disease and IBS

Research unveiled today at the American College of Gastroenterology's (ACG) 77th Annual Scientific meeting in Las Vegas suggests a possible overlap of symptoms of two prevalent GI disorders: irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) and further suggests a possible link between subtle GI tract inflammation and IBS symptoms-a link that is also the focus of the first systemic review of the literature on this topic and an editorial both published in this month's American Journal of Gastroenterology.

23 Oct 2012

Sickle cell disease treatments: An interview with Dr Niihara, CEO of Emmaus Medical

Sickle cell disease is a devastating hereditary condition that affects millions of people, particularly those in West and Central Africa as well as people of African descent in the United States, Europe and South America.

23 Oct 2012

Interim results from CEL-SCI's Multikine Phase III study on head and neck cancer

CEL-SCI Corporation announced today that an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns.

23 Oct 2012

Sanofi presents overview of Phase II and III trials for quadrivalent influenza vaccine

Sanofi Pasteur, the vaccines division of Sanofi, presented today an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine (QIV).

23 Oct 2012

Initiation of dinaciclib Phase 2b/3 CLL trial triggers $2M milestone payment from Merck

Ligand Pharmaceuticals Incorporated today announced that it will receive a $2 million milestone payment from Merck, known as MSD outside the United States and Canada, under the terms of a development and license collaboration for the development of dinaciclib.

22 Oct 2012

GORE Septal Occluder receives FDA approval for use in REDUCE clinical study

W. L. Gore & Associates today announced that the FDA has approved the use of the new GORE Septal Occluder for inclusion in the Gore REDUCE Clinical Study. Gore is introducing this latest technology in its Gore REDUCE Clinical Study for prevention of recurrent stroke in patent foramen ovale (PFO) patients.

22 Oct 2012

PLoS ONE publishes review of AntiViral-HyperActivation Limiting Therapeutics clinical trial

ViroStatics, a private Italian/American biopharmaceutical company developing novel therapeutics for viral and other chronic diseases, announced that a review of the first human clinical trial to test a new class of anti-HIV medications known as AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs) has been published in the peer-reviewed journal PLoS ONE.

22 Oct 2012

Rhythm presents RM-131 Phase 1 clinical trial results for diabetic gastroparesis at ACG 2012

Rhythm announced today the results of two Phase 1 clinical trials of RM-131, the company's novel ghrelin agonist for the treatment of diabetic gastroparesis, which demonstrated that RM-131 greatly accelerates gastric emptying in healthy subjects with good tolerability.

22 Oct 2012

Patients with AF experience more GI bleeding with rivaroxaban use

Patients with atrial fibrillation (AF) experienced more major and non-major clinically relevant GI bleeding when taking rivaroxaban than patients taking warfarin.

22 Oct 2012

Bayer announces data from riociguat Phase III pulmonary arterial hypertension trial

Bayer HealthCare today announced data from the Phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

22 Oct 2012

Drospirenone-containing birth control pills associated with increased risk of blood clots

A U.S. Food and Drug Administration-funded study led by the Kaiser Permanente Northern California Division of Research found an increased risk of arterial thrombotic events (ATE) and venous thromboembolic events (VTE) - commonly referred to as blockage of arteries and blood clots, respectively - associated with drospirenone-containing birth control pills compared to four low-dose estrogen combined hormonal contraceptives.

20 Oct 2012

ACT TIL therapy effective in treating metastatic melanoma

Researchers at Moffitt Cancer Center have carried out a clinical trial in which patients with metastatic melanoma were given chemotherapy and an immunotherapy of adoptive cell transfer (ACT) with tumor infiltrating lymphocytes (TIL).

19 Oct 2012

Linezolid proves effective in treating drug-resistant TB

When tested in patients hospitalized with extensively drug-resistant tuberculosis (XDR-TB) unresponsive to previous treatment, linezolid, an antibiotic used to treat severe bacterial infections, proved largely effective when added to the patients' ongoing TB treatment regimen.

19 Oct 2012

Neuralstem initiates second cohort NSI-189 Phase Ib trial in major depressive disorder

Neuralstem, Inc. announced that it has begun dosing the second cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD).

19 Oct 2012

Long-term multivitamin use associated with prevention of cancer in middle-aged and older men

In a randomized trial that included nearly 15,000 male physicians, long-term daily multivitamin use resulted in a modest but statistically significant reduction in cancer after more than a decade of treatment and follow-up, according to a study appearing in JAMA.

19 Oct 2012

Ustekinumab shows positive results in decreasing debilitating effects of Crohn's Disease

Ustekinumab, an antibody proven to treat the skin condition psoriasis, has now shown positive results in decreasing the debilitating effects of Crohn's Disease, according to researchers at the University of California San Diego, School of Medicine.

18 Oct 2012

Phase 3 study of INLYTA fails to meet primary endpoint in treatment-naïve patients with RCC

Pfizer Inc. announced today that a Phase 3 study of INLYTA (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival, versus sorafenib, in treatment-naïve patients with advanced renal cell carcinoma.

18 Oct 2012

Trial results of first new TB vaccine candidate in 90 years expected next year

"Researchers will find out early next year whether the first new vaccine against tuberculosis [TB] for 90 years protects against a disease that was once neglected but is now resurgent worldwide," Financial Times reports.

18 Oct 2012

Drug Trial News

Abbott announces results from HUMIRA clinical studies on ulcerative colitis

Derma Sciences to initiate DSC127 Phase 3 program in diabetic foot ulcers

Possible overlap exists between inflammatory bowel disease and IBS

Sickle cell disease treatments: An interview with Dr Niihara, CEO of Emmaus Medical

Interim results from CEL-SCI's Multikine Phase III study on head and neck cancer

Sanofi presents overview of Phase II and III trials for quadrivalent influenza vaccine

Initiation of dinaciclib Phase 2b/3 CLL trial triggers $2M milestone payment from Merck

GORE Septal Occluder receives FDA approval for use in REDUCE clinical study

PLoS ONE publishes review of AntiViral-HyperActivation Limiting Therapeutics clinical trial

Rhythm presents RM-131 Phase 1 clinical trial results for diabetic gastroparesis at ACG 2012

Patients with AF experience more GI bleeding with rivaroxaban use

Bayer announces data from riociguat Phase III pulmonary arterial hypertension trial

Drospirenone-containing birth control pills associated with increased risk of blood clots

ACT TIL therapy effective in treating metastatic melanoma

Linezolid proves effective in treating drug-resistant TB

Neuralstem initiates second cohort NSI-189 Phase Ib trial in major depressive disorder

Long-term multivitamin use associated with prevention of cancer in middle-aged and older men

Ustekinumab shows positive results in decreasing debilitating effects of Crohn's Disease

Phase 3 study of INLYTA fails to meet primary endpoint in treatment-naïve patients with RCC

Trial results of first new TB vaccine candidate in 90 years expected next year

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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