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.
02 December 2016 | Pink News
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.
28 November 2016 | Seeking Alpha
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.
22 November 2016 | STAT
Studies will investigate monthly dosing with injectable cabotegravir and rilpivirine
21 November 2016 | ViiV press release
Life-saving HIV drugs were allegedly diverted from Africa's public health system to sell in Europe.
17 November 2016 | Bhekisisa
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."
17 November 2016 | HIV Prevention Justice Alliance
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.
17 November 2016 | The Body
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...."
16 November 2016 | Gilead Sciences
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.
09 November 2016 | Pharma Times
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.
08 November 2016 | Washington Post