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CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV).

19 Feb 2014

Matching the right tumor with the right drug

There are three common drugs for advanced ovarian cancer: paclitaxel, cyclophosphamide, and topotecan. Like a shell game, if you pick the right drug a patient is likely to respond. And, unfortunately, picking the wrong drug can lead to treatment failure. As reported in this month's issue of the journal PLoS ONE, a University of Colorado Cancer Center and University of Virginia study used a sophisticated model of ovarian cancer genetics to match the right tumor with the right drug. Patients who were matched in this way lived an average 21 months longer than patients who were not matched.

19 Feb 2014

Update Pharma's UPI-928 gets FDA orphan drug designation for AML treatment

Update Pharma Inc. today announced that the FDA has approved Orphan Drug Status for the use of UPI-928 for the treatment of Acute Myeloid Leukemia (AML).

18 Feb 2014

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration granted accelerated approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH.

18 Feb 2014

New research points to potential target for treating triple negative breast cancer

New research from the University of Michigan Comprehensive Cancer Center and Georgia Regents University finds that a protein that fuels an inflammatory pathway does not turn off in breast cancer, resulting in an increase in cancer stem cells. This provides a potential target for treating triple negative breast cancer, the most aggressive form of the disease.

17 Feb 2014

Commonly-used HIV drug kills HPV that leads to cervical cancer

A commonly-used HIV drug has been shown to kill-off the human papilloma virus (HPV) that leads to cervical cancer in a world-first clinical trial led by The University of Manchester with Kenyatta National Hospital in Nairobi.

17 Feb 2014

Altrient C improves skin firmness and elasticity by 32.7%

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17 Feb 2014

Highlights: N.D. hospital and abortion docs; Calif. sugary beverage bill; aging home care workers in Texas

A Democratic candidate who has explicitly defended Obamacare holds a slight lead in a special congressional election in Florida that both parties are eyeing as a test of the political impact of the healthcare law. A poll released Thursday by the Tampa Bay Times shows Democrat Alex Sink leading her Republican opponent, David Jolly, 42% to 35% among people considered likely to vote in the March 11 special election.

17 Feb 2014

Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Forest Laboratories, Inc., a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, today announced that it plans to discontinue the sale of NAMENDA (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014.

16 Feb 2014

Research roundup: Examining readmissions; easing doctor burnout

Despite massive early IT problems, exchange enrollment is accelerating rapidly. While enrollment may not reach 7 million by the end of March, we expect at least 5 million to have enrolled by the close of the initial open-enrollment period. If enrollment falls far short, HHS could extend open enrollment for a fixed period to reach its 7 million target. ... We project that 5 million new beneficiaries will be covered by Medicaid and the Children's Health Insurance Program by the end of 2014. Medicaid managed-care enrollment of non-dual beneficiaries will increase by 20 percent from 2013 to 2014 and by 38 percent from 2013 to 2016. We expect that 75 percent of non-dual Medicaid beneficiaries will be covered by Managed Care Organizations starting in 2015, up from 63 percent in 2012 (Feb. 2014).

14 Feb 2014

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that the National Institute of Allergy and Infectious Diseases has awarded Soligenix a Small Business Innovation Research grant to support further preclinical development of SGX943 as a treatment for melioidosis.

14 Feb 2014

FAST-MAG clinical trial finds that magnesium does not improve stroke-related disability

In the first study of its kind, a consortium led by UCLA physicians found that giving stroke patients intravenous magnesium within an hour of symptom onset does not improve stroke outcomes, according to research presented today at the American Stroke Association's International Stroke Conference.

14 Feb 2014

Intravenous magnesium fails to improve stroke-related disability

Giving intravenous magnesium to stroke patients soon after the start of symptoms, in an attempt to protect brain cells deprived of oxygen, failed to improve stroke-related disability 3 months later, according to research presented at the American Stroke Association's International Stroke Conference 2014

13 Feb 2014

FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc., a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.

13 Feb 2014

FDA grants full approval of SYNRIBO for injection

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

13 Feb 2014

GenVec achieves third milestone for development of treatments for hearing and balance disorderstion

GenVec, Inc. (NASDAQ: GNVC) today announced that the company has achieved the third milestone in its collaboration with Novartis for the development of treatments for hearing and balance disorders.

13 Feb 2014

Cogstate technology to be applied in paediatric clinical trial in the U.S.

Medical technology company Cogstate Limited has today announced its technology will be used in a large paediatric clinical trial in the United States.

12 Feb 2014

PAREXEL launches marketing initiative to simplify journey from science to new treatments

As the global biopharmaceutical industry increasingly seeks to streamline the complex process of bringing new drugs to market, PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced the launch of a new marketing initiative that highlights the Company's proven approach to help clients simplify the journey from science to new treatments.

From Parexel 12 Feb 2014

MIT develops robot that may speed up drug development for stroke patients

The development of drugs to treat acute stroke or aid in stroke recovery is a multibillion-dollar endeavor that only rarely pays off in the form of government-approved pharmaceuticals.

12 Feb 2014

Avaxia Biologics receives patent for oral anti-TNF antibodies for treatment of IBD

Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced today that the company was awarded U.S. Patent No. 8,647,626, entitled "Compositions Comprising TNF-specific Antibodies for Oral Delivery."

12 Feb 2014

Clinical Trial News and Research

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

Matching the right tumor with the right drug

Update Pharma's UPI-928 gets FDA orphan drug designation for AML treatment

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

New research points to potential target for treating triple negative breast cancer

Commonly-used HIV drug kills HPV that leads to cervical cancer

Altrient C improves skin firmness and elasticity by 32.7%

Highlights: N.D. hospital and abortion docs; Calif. sugary beverage bill; aging home care workers in Texas

Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Research roundup: Examining readmissions; easing doctor burnout

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

FAST-MAG clinical trial finds that magnesium does not improve stroke-related disability

Intravenous magnesium fails to improve stroke-related disability

FDA accepts Regado Biosciences' IND application for REG2

FDA grants full approval of SYNRIBO for injection

GenVec achieves third milestone for development of treatments for hearing and balance disorderstion

Cogstate technology to be applied in paediatric clinical trial in the U.S.

PAREXEL launches marketing initiative to simplify journey from science to new treatments

MIT develops robot that may speed up drug development for stroke patients

Avaxia Biologics receives patent for oral anti-TNF antibodies for treatment of IBD

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