Democratic presidential nominee Hillary Clinton said Wednesday her administration will go after drug companies that charge exorbitant prices, singling out the company Gilead, whose hepatitis C drugs cost between $900 and $1,000 per pill in the United States.
19 August 2016 | UPI.com
In pointed remarks, Germany’s cost-effectiveness watchdog has criticised an effort by European regulators to accelerate approval for new medicines by limiting its requirements for evidence. The concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs. At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago,an EMA pilot programme was launched to compare initial data used for approval with so-called “real world” data, which is subsequently gathered after the medicines are in use.
18 August 2016 | STAT
New, highly curative hepatitis C therapy is both safe and effective as a treatment option for people who inject drugs receiving opioid substitution therapy according to the results of a world-first clinical trial led by Professor Gregory Dore at the Kirby Institute at UNSW Australia and published today in the Annals of Internal Medicine.
15 August 2016 | EurekAlert
MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (MRK)) today announced that the European Commission has approved ZEPATIER™ (elbasvir/grazoprevir) with or without ribavirin (RBV) for the treatment of chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults.
02 August 2016 | MSD press release
Today, as Addaction host a large conference at The British Medical Association in London for World Hepatitis Day, the charity calls for an urgent review of the decision to ration clinically proven treatments to just 10,000 people with the virus per year, limiting access to new drugs that can effectively treat nine out of every ten carriers of the virus.
28 July 2016 | Addaction
Doctors are predicting the eradication of hepatitis C from Australia by 2026 after a dramatic take-up of new-generation "revolutionary" drugs. Nearly 22,500 patients have commenced treatment since the drugs were listed on the Pharmaceutical Benefits Scheme in March, representing about 10 per cent of all people who are estimated to be living with hepatitis C.
28 July 2016 | Sydney Morning Herald
NHS England tried to sabotage the release of hepatitis C drugs because it couldn't afford them, it has been claimed. Under current procedures, drugs approved by Nice typically become widely available to NHS patients after a statutory period of 90 days. However, the BMJ claims: “In an apparent panic over high prices and affordability, NHS England deployed many delaying tactics to block timely access to the hepatitis C drugs.”
28 July 2016 | The Independent
AbbVie announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.
26 July 2016 | AbbVie press release
The World Health Organization has issued updated information on the patent status of hepatitis C medicines, including assessments of hurdles for affordable generic versions of latest drugs.
21 July 2016 | Intellectual Property Watch
With some 400 million people around the world infected with hepatitis B or C, the United Nations health agency today encouraged countries to boost testing and access to services and medicines for people in need.
21 July 2016 | UN News Centre