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ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV

ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for Tentative Approval, to the Food and Drug Administration (FDA), for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay® (dolutegravir) for sale in the United States. Upon receiving Tentative Approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.

Published
19 hours ago
From
ViiV Healthcare
New York Governor Announces PrEP Assistance Program

New York Governor Andrew Cuomo announced last week a new pre-exposure prophylaxis assistance program that proponents say will help to end the AIDS epidemic in the state by 2020. The country's first-of-its-kind program will help at-risk groups, including gay and bi men and transgender women, obtain testing, medication, and counseling.

Published
22 hours ago
From
HIVPlusMag
World Health Assembly: Experts discuss delinking drug R&D costs from pricing to make them affordable

The problem of drug prices eating up national health budgetscame up at the annual World Health Assembly, which took place from 18-26 May. Last week, a panel of experts discussed the merits of lowering those prices by delinking research and development costs from pricing.

Published
26 May 2015
From
Intellectual Property Watch
NHS England accused of interference over hepatitis C drug

Officials at NHS England have been accused of interfering in a process to decide whether a drug which can cure Hepatitis C should be made available to patients on the health service.

Published
26 May 2015
From
Channel 4 News
Fighting HIV where no-one admits it's a problem

For years Russia has remained remarkably silent on the challenge it faces from HIV and Aids. Now that silence has been broken by an epidemiologist who has been working in the field for more than two decades - and he calls the situation "a national catastrophe".

Published
20 May 2015
From
BBC
Prioritisation is crucial for the success of PrEP, model confirms

A mathematical model developed by two researchers at Imperial College in London, and based on what would happen if pre-exposure prophylaxis (PrEP) was introduced to a high-prevalence

Published
20 May 2015
By
Gus Cairns
Moscow police detain HIV activists over drug cost picket

Police in Moscow have briefly detained eight activists who picketed outside the presidential administration's headquarters to protest the high cost of HIV treatments in Russia.

Published
14 May 2015
From
Yahoo News
Sanders Asks VA to Break Patents on Gilead and AbbVie Hep C Drugs

The ongoing debate over the cost of prescription drugs took another twist as U.S. Sen. Bernie Sanders (I-VT.) has asked the U.S. Department of Veterans Affairs to use emergency powers to break – or override – the patents on high-priced hepatitis C drugs.

Published
13 May 2015
From
Wall Street Journal (blog)
WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers

WHO today published the new edition of its Model List of Essential Medicines which includes ground-breaking new treatments for hepatitis C, a variety of cancers (including breast cancer and leukaemia) and multi-drug resistant tuberculosis (TB), among others.

Published
11 May 2015
From
World Health Organization
Gilead: Stop Blocking Access to Hepatitis C Treatment

On the eve of pharmaceutical company Gilead Sciences’ annual shareholder meeting, thousands of people who have hepatitis C virus (HCV) and HCV/HIV coinfection, with their allies and physicians, have demanded that Gilead change its policies that deny access to treatment for millions of people in developing countries.

Published
05 May 2015
From
Treatment Action Group
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