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Scientists find major shortcomings in assessing CVD risk in HIV patients

At the same time that medical science has nearly eliminated AIDS deaths in patients treated for human immunodeficiency virus, two international meetings of HIV/AIDS scientists and patient advocates find major shortcomings in the design and analysis of studies used to assess cardiovascular disease risk in people with HIV with significant implications for improving medical care.

20 Jul 2010

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

MDMA (-3,4-methylenedioxymethamphetamine, also known as Ecstasy), may one day offer hope for individuals with posttraumatic stress disorder (PTSD), even people for whom other treatments have failed. Clinical trial results out today in the Journal of Psychopharmacology, published by SAGE, suggests that MDMA can be administered to subjects with PTSD without evidence of harm and could offer sufferers a vital window with reduced fear responses where psychotherapy can take effect.

20 Jul 2010

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

A Phase 3 open-label study, recently published online by Pain Practice, has compared tapentadol extended release tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release tablets.

20 Jul 2010

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

Pfizer Inc. today announced, at the request of the U.S. Food and Drug Administration (FDA), the suspension of the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

20 Jul 2010

Univfy, Stanford scientists develop first validated prognostic test for predicting IVF live birth outcomes

Univfy, a pioneer in the development of personalized in vitro fertilization (IVF) prognostic tools, announced today the publication of new research findings in the journal Proceedings of the National Academy of Sciences (PNAS) by its founding scientific team and clinical collaborators from Stanford University.

20 Jul 2010

Vertos Medical announces 12-week data from MiDAS I clinical study for lumbar spinal stenosis

Medical device company Vertos Medical Inc. has announced the unveiling of 12-week clinical data from its prospective, 75-patient MiDAS I (mild Decompression Alternative to open Surgery) study that further validate the safety and efficacy of mild for the treatment of lumbar spinal stenosis (LSS). Consistent with the positive six-week study results released in March and May, the new MiDAS I data demonstrate that mild patients continued to experience statistically significant improvement in pain, physical function and mobility 12 weeks following treatment.

20 Jul 2010

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. today announced the initiation of the pivotal Phase III clinical trial for palifosfamide in patients with front-line metastatic soft tissue sarcoma. The study, called PICASSO 3, is an international, randomized, double-blinded, placebo-controlled trial designed to enroll approximately 424 patients with metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.

20 Jul 2010

'Sloppy' practices at brain imaging center could have far-reaching repercussions for brain research

The Los Angeles Times: "The suspension of some research at a prominent Columbia University brain-imaging lab because of sloppy practices could have repercussions beyond that laboratory, potentially affecting brain-imaging studies nationwide and raising questions about the safety of participants, research experts said Saturday.

20 Jul 2010

FDA joins Tox21 collaboration for improved chemical screening

The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods.

20 Jul 2010

AU Summit focusing on maternal, child health begins in Uganda

Delegations arrived in Kampala, Uganda, for the start of the 15th African Union (AU) Summit, which begins Monday, the Daily Monitor reports (Muyita/Kasasira, 7/19).

20 Jul 2010

Unidine, Xanitos enter strategic partnership

Unidine Corporation, a leading provider of food service management to healthcare and businesses, and Xanitos, Inc., an innovator in EVS management systems for hospitals, today announced a strategic partnership to offer combined food and dining service management and EVS management for hospitals that desire superior quality, personalized attention and the convenience of two industry leaders that share a common philosophy.

19 Jul 2010

Bayat Foundation commences construction on 50-bed maternity hospital in Lashkargah

The Bayat Foundation laid the cornerstone to begin construction on a 50-bed maternity hospital in Lashkargah, the capital of Helmand, Afghanistan's largest province. When completed later this year, the Fatema Bayat Maternity Hospital will include an operation and recovery room, pharmacy, waiting hall, kitchen, and power system to provide vital access to quality medical care.

19 Jul 2010

Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Oncolytics Biotech Inc. today announced that it has received a No Objection Letter from Health Canada to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.

19 Jul 2010

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL).

19 Jul 2010

FDA approves Mylan's ANDA for generic Catapres-TTS

Mylan Inc. today announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS®, a treatment for hypertension.

19 Jul 2010

Artificial colours in food linked to cancer and behavioral disorders in children: Study

Artificial colours in foods, scientists have found may increase the risk of getting cancer, allergies and may trigger hyperactivity in susceptible children. This new report entitled, “Food Dyes: A Rainbow of Risks”, has come from the research conducted by the Centre for Science in the Public Interest (CSPI).

18 Jul 2010

Center for Regulatory Effectiveness concerned over undue influence by agency on tobacco advisory panel

The watchdog group Center for Regulatory Effectiveness (CRE) today urged the Commissioner of the Food and Drug Administration (FDA) to assure that advice provided by a tobacco advisory committee on menthol cigarettes is "independent and not influenced by agency staff" in accordance with federal law.

17 Jul 2010

Species with larger brains live longer

"In the past, it was thought that one of the selective advantages of having a large brain is that it facilitates the development of new behaviour to respond to the ecological challenges that the individual has not experienced before, such as a sudden reduction in food or the appearance of a new predator ", C-sar Gonz-lez-Lagos, main author of the study and researcher at the Centre of Ecological Research and Forestry Applications (CREAF) associated with the Autonomous University of Barcelona, highlights to SINC.

17 Jul 2010

New tactics for repelling, controlling disease-carrying insects

In the battle between insect predators and their prey, chemical signals called kairomones serve as an early-warning system. Pervasively emitted by the predators, the compounds are detected by their prey, and can even trigger adaptations, such a change in body size or armor, that help protect the prey. But as widespread as kairomones are in the insect world, their chemical identity has remained largely unknown. New research by Rockefeller University's Joel E. Cohen and colleagues at the University of Haifa in Israel has identified two compounds emitted by mosquito predators that make the mosquitoes less inclined to lay eggs in pools of water.

17 Jul 2010

Lorillard calls upon FDA TPSAC to employ dispassionate science in evaluation of menthol in cigarettes

With the words of Food and Drug Commissioner Margaret Hamburg on the screen beside him, a Lorillard Tobacco Company scientist today called upon the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) to employ a "truly science-based, data-driven" process in its evaluation of menthol in cigarettes. Earlier this week Hamburg made headlines when she told an FDA science panel to "Follow the science wherever it leads and the rest will fall into place."

17 Jul 2010

Food News and Research

Scientists find major shortcomings in assessing CVD risk in HIV patients

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

Univfy, Stanford scientists develop first validated prognostic test for predicting IVF live birth outcomes

Vertos Medical announces 12-week data from MiDAS I clinical study for lumbar spinal stenosis

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

'Sloppy' practices at brain imaging center could have far-reaching repercussions for brain research

FDA joins Tox21 collaboration for improved chemical screening

AU Summit focusing on maternal, child health begins in Uganda

Unidine, Xanitos enter strategic partnership

Bayat Foundation commences construction on 50-bed maternity hospital in Lashkargah

Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

FDA approves Mylan's ANDA for generic Catapres-TTS

Artificial colours in food linked to cancer and behavioral disorders in children: Study

Center for Regulatory Effectiveness concerned over undue influence by agency on tobacco advisory panel

Species with larger brains live longer

New tactics for repelling, controlling disease-carrying insects

Lorillard calls upon FDA TPSAC to employ dispassionate science in evaluation of menthol in cigarettes

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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