Clinical Trial News and Research

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Positive top-line results from Biogen BG-12 Phase 3 trial in RRMS

Biogen Idec announced today positive top-line results from DEFINE, the first of two pivotal Phase 3 clinical trials designed to evaluate the investigational oral compound BG-12 as a monotherapy in people with relapsing-remitting multiple sclerosis.

11 Apr 2011

Study shows how specific nutritional combination may help maintain healthy breast tissue

Researchers from Canada and the United States today told attendees of the Experimental Biology 2011 Scientific Meeting that they have uncovered a possible means of enabling women to favorably influence whether the estrogens in their bodies take a "beneficial path" or a "disease-potential" path.

11 Apr 2011

Enigma initiates ML system trial in patients with influenza

Enigma Diagnostics announced today that it has commenced clinical trials for its intended point of care Enigma ML Influenza A/B detection assay. Enigma will submit its application to the U.S. Food and Drug Administration for approval of the assay in 2012.

11 Apr 2011

Research on rare cancers

A cancer diagnosis can be a life-changing event. Many questions arise, with one of the first being, "Where should I be treated?" Patients diagnosed with rare cancers may have difficulty finding a physician knowledgeable in treating their type of cancer.

11 Apr 2011

Synexus' Chief Medical Officer to discuss vaccine trial challenges at Washington event

Dr Glynis Neagle, Synexus' Chief Medical Officer will be discussing the challenges facing global vaccine trials at the World Vaccine Congress in Washington this week.

From AES - Accelerated Enrollment Solutions 11 Apr 2011

Annals of Neurology publishes Diamyd Medical´s NP2 Enkephalin Phase I results in cancer pain

Diamyd Medical´s Phase I clinical trial results evaluating the safety and efficacy of the candidate drug NP2 Enkephalin to treat intractable cancer pain has been published in the medical journal Annals of Neurology.

11 Apr 2011

New point-of-care trial can reduce cost and length of studies

Doctors at the Veterans Affairs Boston Healthcare System are testing a new kind of clinical trial that's not only less costly but guides doctors to switch to the best treatment even before the trial is completed.

11 Apr 2011

Merck announces interim analysis from V710 Phase II/III trial in S. aureus infection

Merck, known as MSD outside the United States and Canada, and Intercell AG today announced that following a pre-specified interim analysis from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus infection, the independent Data Monitoring Committee recommended suspension of enrollment.

11 Apr 2011

Gilenya can reduce risk of disability progression in patients with RRMS

A new analysis demonstrated that Gilenya reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history. This analysis of the phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being presented at the 63rd annual meeting of the American Academy of Neurology.

11 Apr 2011

Scientists identify new treatment to combat PFAPA syndrome in children

A preliminary study conducted by a team at the National Institutes of Health has identified a promising new treatment in children for the most common form of a rare disorder.

11 Apr 2011

IDSA, U.S. health officials describe ways to respond to global threat of antimicrobial resistance

To coincide with World Health Day on Thursday, the Infectious Diseases Society of America (IDSA) released a policy paper with nine recommendations for how to control the "ever-growing threat of antimicrobial resistance," CIDRAP News reports.

11 Apr 2011

Investigational drug effective for patients with obesity

An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.

11 Apr 2011

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

Antares Pharma, Inc. today announced the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology.

8 Apr 2011

An essential 'cookbook' for clinical trials

For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with.

8 Apr 2011

NEJM: Perspectives from Aaron, Reinhardt, Iglehart, Annas, Chambers and others

This week's New England Journal of Medicine features perspectives from prominent authors on Medicare and Medicaid. NEJM granted KHN permission to excerpt substantial portions of these columns.

8 Apr 2011

Long-term delivery of CNTF slows loss of visual acuity caused by geographic atrophy

A phase 2 clinical trial for the treatment of a severe form of age-related macular degeneration called geographic atrophy (GA) has become the first study to show the benefit of a therapy to slow the progression of vision loss for this disease. The results highlight the benefit of the use of a neurotrophic factor to treat GA and provide hope to nearly one million Americans suffering from GA.

8 Apr 2011

Physician's documentation confirms successful treatment of basal cell carcinoma with topical cannabis extract

Cannabis Science, Inc., US biotech company developing pharmaceutical cannabis products. On March 9, 2011 Cannabis Science announced that we would follow up our press release with medical documentation regarding the effectiveness of our cannabis extracts for treating skin cancer as was documented photographically in our earlier press release of February 22, 2011.

7 Apr 2011

DSP, BBI sign license agreement for BBI608

Dainippon Sumitomo Pharma Co., Ltd. and Boston Biomedical, Inc., today announced that they have signed a Product Option License Agreement for BBI608 for all oncology indications in Japan and exclusive right of negotiation for BBI608 for the United States and Canada.

7 Apr 2011

Southwest Oncology Group is now 'SWOG'

The Southwest Oncology Group is now simply "SWOG."

7 Apr 2011

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

GlaxoSmithKline and XenoPort, Inc. announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night.

7 Apr 2011

Clinical Trial News and Research

Positive top-line results from Biogen BG-12 Phase 3 trial in RRMS

Study shows how specific nutritional combination may help maintain healthy breast tissue

Enigma initiates ML system trial in patients with influenza

Research on rare cancers

Synexus' Chief Medical Officer to discuss vaccine trial challenges at Washington event

Annals of Neurology publishes Diamyd Medical´s NP2 Enkephalin Phase I results in cancer pain

New point-of-care trial can reduce cost and length of studies

Merck announces interim analysis from V710 Phase II/III trial in S. aureus infection

Gilenya can reduce risk of disability progression in patients with RRMS

Scientists identify new treatment to combat PFAPA syndrome in children

IDSA, U.S. health officials describe ways to respond to global threat of antimicrobial resistance

Investigational drug effective for patients with obesity

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

An essential 'cookbook' for clinical trials

NEJM: Perspectives from Aaron, Reinhardt, Iglehart, Annas, Chambers and others

Long-term delivery of CNTF slows loss of visual acuity caused by geographic atrophy

Physician's documentation confirms successful treatment of basal cell carcinoma with topical cannabis extract

DSP, BBI sign license agreement for BBI608

Southwest Oncology Group is now 'SWOG'

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

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