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European CHMP Adopts Positive Opinion for Stribild®, a Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection

Gilead Sciences today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)).

Published
7 hours ago
From
Gilead press release
EU new drug approval studies "have too few patients to evaluate safety"

For medicines intended for chronic use, the number of patients studied before regulatory approval in the European Union (EU) is insufficient to properly evaluate safety and long-term efficacy, and this points to a need for new EU legislation, say researchers writing in this week's PLOS Medicine.

Published
11 hours ago
From
Pharma Times
The Union offers hope and practical advice on multidrug-resistant tuberculosis

The Union is marking World TB Day this year by publishing a new guide that offers clear, practical advice on one of the trickiest aspects of "stopping TB" – how to manage the estimated 310,000 patients who have multidrug-resistant TB (MDR-TB).

Published
21 March 2013
From
International Union Against Tuberculosis and Lung Disease
Congress Cuts Funding For State ADAP Programs

The failure of a US Senate spending bill to include $35 million in funding for HIV medications will jeopardize the ability of state AIDS Drug Assistance Programs to offer prescription drugs to nearly 8,000 low-income people living with the virus, according to patient advocates.

Published
21 March 2013
From
Pharmalot
Advocates See Historic Chance to Turn Tide on TB

Patients, doctors and international aid groups are calling on donors and governments to support measures that would make treatment of drug-resistant tuberculosis more effective and accessible.

Published
21 March 2013
From
Inter Press Service
Self-testing and home treatment initiation triples uptake of HIV treatment in Malawi

Offering people the opportunity to self-test at home and then start antiretroviral therapy after counselling at home, together with home delivery of antiretroviral drugs, increased the number

Published
21 March 2013
By
Keith Alcorn
UNAIDS calls for Zero parallel systems for HIV and TB

UNAIDS is calling for Zero parallel systems for HIV and TB. This means that HIV and TB systems should be fully integrated, every person living with HIV is tested for TB and that every person with TB is offered an HIV test, and people with TB who are HIV-positive are started on antiretroviral treatment immediately.

Published
20 March 2013
From
UNAIDS
In the new NHS lawyers, not GPs, will be in the driving seat

With less than two weeks to go before clinical commissioning groups (CCGs) take responsibility for almost all our healthcare, they still don't know officially whether they will be free to go on commissioning work from NHS hospitals, or whether they will be forced to open it up to private providers.

Published
20 March 2013
From
The Guardian
Sluggish response risks squandering historic opportunity to tackle global drug-resistant tuberculosis

If measures to tackle multidrug-resistant tuberculosis (MDR-TB) are not significantly stepped up, including addressing barriers that prevent both research into better drug combinations and treatment scale up, MDR-TB rates will continue to increase worldwide and a historic opportunity to improve abysmal cure rates will have been squandered, medical humanitarian organisation Médecins Sans Frontières (MSF) warned today.

Published
20 March 2013
From
MSF
Sofosbuvir plus ribavirin works well for hard-to-treat inner-city hepatitis C patients

A simple 24-week oral regimen consisting of sofosbuvir plus full-dose ribavirin cured nearly 70% of previously untreated people with genotype 1 hepatitis C, many of whom had

Published
20 March 2013
By
Liz Highleyman
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