Regulus announces continuation of RG-101 clinical hold

Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for RG-101 remains on clinical hold. In ...

January 31, 2017
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Final yes from NICE for Gilead’s Epclusa

The National Institute for Health and Care Excellence has now published final guidance endorsing Epclusa as an option for the treatment of adults with chronic hepatitis C genotype 1-6 infection on the NHS in England and Wales. Epclusa – a once-daily, fixed-dose combination of the nucleotide ...

January 27, 2017
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Food is medicine for HIV-positive and type 2 diabetes patients

Study finds good nutrition improves medication adherence and mental health HIV-positive people who received healthy food and snacks for six months were more likely to adhere to their medication regimens, and they, as well as people with type 2 diabetes, were less depressed and less likely ...

January 26, 2017
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New and touted HIV bNAb: Big deal or news blip?

Fervid research has uncovered dozens of antibodies that shield cells from HIV. These broadly neutralizing antibodies (bNAbs) protect monkeys from SHIV, the simian-HIV hybrid. Thousand-person human trials are already dripping bNAbs into high-risk men and women to see if they prevent HIV infection. And much ...

January 26, 2017
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Antibody combination puts HIV on the ropes

Without antiretroviral drug treatment, the majority of people infected with HIV ultimately develop AIDS, as the virus changes and evolves beyond the body’s ability to control it. But a small group of infected individuals—called elite controllers—possess immune systems capable of defeating the virus. They accomplish ...

January 26, 2017
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Medicines Patent Pool announces first licence for TB treatment

In an effort to improve the international response to combatting multidrug-resistant TB, MPP and Johns Hopkins University sign licensing agreement for investigational treatment sutezolid Geneva, 25 January 2017 — The Medicines Patent Pool today announced that it has signed a licence with Johns Hopkins University ...

January 26, 2017
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EMA grants accelerated assessment, validates Marketing Authorization Application for AbbVie’s investigational hepatitis C therapy

European Medicines Agency grants accelerated assessment, validates Marketing Authorization Application for AbbVie’s investigational regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C in all major genotypes (GT1-6) – If approved, G/P may provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority ...

January 25, 2017
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Gene therapy to cure HIV: Where to from here?

Gene therapy — which involves modifying genetic material, such as DNA and RNA — holds exciting potential as a cure for numerous diseases and conditions, including HIV. Timothy Brown (the “Berlin patient”) remains the only person known to have been cured of HIV. Brown received a ...

January 25, 2017
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Cognitive decline in hepatitis C could be influenced by interferon treatment

A group of researchers is investigating whether or not interferon-free therapy could reverse the cognitive declines that appear to accompany infection with the hepatitis C virus (HCV), with or HIV coinfection. Felix Kleefeld, of Berlin, Germany, and colleagues examined how eradicating HCV affected the cognition of ...

January 24, 2017
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Immediate ART for HIV protects against severe bacterial infections

Initiating, rather than deferring, antiretroviral therapy (ART) reduces the risk of severe bacterial infections in HIV-positive individuals with high CD4 counts, researchers say. Their data are from the START trial, which showed a 57% reduction in the risk of AIDS and non-AIDS morbidity and mortality in ...

January 24, 2017
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The war on drugs causes massive human rights violations

Experts discuss the devastating effects of prohibition and their reasons for reform The war on drugs has had devastating effects on human rights and public health worldwide, argue experts in The BMJ. In November, the journal argued that prohibition laws have failed and called on doctors to ...

January 24, 2017
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Uzbekistan: Pioneering clinical trial for drug-resistant TB starts

A pioneering new clinical trial aiming to find a radically improved course of treatment for drug-resistant tuberculosis (TB) began on 17th January 2017, when the first patient took the first pill in Uzbekistan. The phase II/III trial, called TB PRACTECAL, aims to find a treatment regime ...

January 24, 2017
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EMA report: Conditional marketing authorisation – 10 years of experience

Conditional marketing authorisations give patients access to important new medicines earlier EMA publishes report with data collected between 2006 and June 2016 Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs. Since 2006, a total of 30 medicines have received ...

January 24, 2017
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