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MP calls for PrEP manufacturer to submit to Scottish regulator

The Scottish Medicines Consortium is responsible for approving all drugs available on the NHS in Scotland and the Glasgow South MP has called for the company to make a submission, so it can form part of the country’s HIV prevention strategy.

Published
02 December 2016
From
Pink News
Gilead's HIV Business Is More Cash Cow Than Shining Star

Gilead's market share will remain stable or increase in next few years as a result of TAF single tablet regimens. However, market share will decrease in long term as generics, new STRs, further PrEP drugs, new drug classes, and long-acting treatment becomes available. Gilead to decrease pipeline focus on HIV.

Published
28 November 2016
From
Seeking Alpha
Could the FDA be dismantled under Trump?

Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration? The agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials.

Published
22 November 2016
From
STAT
ViiV Healthcare launches phase III programme to evaluate a long-acting, injectable HIV treatment regimen

Studies will investigate monthly dosing with injectable cabotegravir and rilpivirine

Published
21 November 2016
From
ViiV press release
Exposed: Southern African trio 'sold expired ARVs' in Europe at a 4 000% markup

Life-saving HIV drugs were allegedly diverted from Africa's public health system to sell in Europe.

Published
17 November 2016
From
Bhekisisa
Community demand for temporary halt to Gilead DISCOVER study

A group of U.S., Canadian, and European community advocates and HIV NGO workers have written a letter exrpesing "deep dismay" that Gilead Sciences have proceeded with the DISCOVER trial PrEP"without engaging stakeholders in a substantial or meaningful way.". DISCOVER will compared Gilead's new comination pill, Descovy against Truvada as PrEP. In 2007, the HIV/AIDS field adopted Good Participatory Practice (GPP), a formal set of guidelines approved by UNAIDS for stakeholder engagement in HIV prevention clinical trials. "It is astonishing," says the letter, "that Gilead has failed to follow GPP guidelines in the design and implementation of DISCOVER, since GPP was developed partly as a response to the failure of previous prevention trials involving tenofovir."

Published
17 November 2016
From
HIV Prevention Justice Alliance
Why Are HIV Groups Charging Gilead With Bad Behavior in New PrEP Trial?

Gilead is not following the accepted standard for community engagement in its new pre-exposure prophylaxis (PrEP) trial, and we are among a coalition of HIV activists and organizations from Europe and North America calling them out on their bad corporate behavior. We root our criticism in the Good Participatory Practice (GPP) guidelines that were inspired, in part, by controversies in earlier PrEP trials.

Published
17 November 2016
From
The Body
Statement on DISCOVER Study of F/TAF for PrEP

Gilead Sciences released this statement after considerable interest and concerns abut the forthcoming study of their new tenofovir formulation, TAF, for use in PrEP. The TAF/FTC pill is called Descovy(R). "Gilead Sciences is sponsoring a clinical trial, known as the DISCOVER study, to test whether a combination of emtricitabine and tenofovir alafenamide (F/TAF) is as safe and effective as Truvada® (emtricitabine and tenofovir disoproxil fumarate, F/TDF) at reducing the risk of HIV infection when used as pre-exposure prophylaxis (PrEP). F/TAF was recently approved for HIV treatment, but it is not yet known whether it is effective as PrEP...."

Published
16 November 2016
From
Gilead Sciences
‘Hard’ Brexit would delay access to new drugs, warns report

UK patients could see delays in access to new medicines if Brexit means leaving the single market, warns a new report published by think tank Public Policy Projects backed by health consultancy giant QuintilesIMS.

Published
09 November 2016
From
Pharma Times
These researchers think they have a solution to the global crisis in drug prices

To avoid the cost and uncertainty of challenging behemoth drug companies in the American market, Trek plans to focus on middle-income countries where new hepatitis C drugs have been slow to roll out, such as nations in eastern and central Europe. If they are successful at finding a new balancing point of profit and access -- a true "if" -- they hope their example could inspire companies working on other diseases to experiment with similar pricing models.

Published
08 November 2016
From
Washington Post
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

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