PharmExec Blog

NIH Begins Human Safety Study of Ebola Candidate Vaccine

Initial human testing on a vaccine to prevent Ebola virus co-developed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and GlaxoSmithKline (GSK) has begun. The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp.

NIH is testing the NIAID/GSK vaccine in partnership with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development. Healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali will participate in the testing.

The experimental NIAID/GSK vaccine will be conducted among 20 healthy adults ages 18-50 years. Participants will be divided into two groups of 10 participants each. One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine, and the second group will receive a single injection of the same vaccine but at a higher dose.

Human safety testing for experimental Ebola vaccines is being expedited because of the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.

NIAID will also test a version of the NIAID/GSK vaccine that contains a genetic material from the Zaire Ebola species. Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.

Source: NIH

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Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year.

It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify and harmonize the administrative provisions for clinical trials of investigational medicinal products across the EU but did not achieve this, because, as it has been implemented differently across member states. It is also blamed for increasing the administrative and regulatory burden in the EU, making it a less attractive location for running clinical trials. However, it cannot be solely attributed to the Clinical Trials Directive that the number of clinical trials in Europe has declined, and the costs of trials have increased since it was implemented but it does appear to have contributed significantly to this. Read More »

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UK’s Controversial Cancer Fund Boosted — But What’s the Long-Term Plan?

By Leela Barham.

The English Cancer Drugs Fund (CDF), set up to provide funding for those products that the National Institute for Health and Care Excellence (NICE) has not recommended for use or where their guidance isn’t yet available, remains controversial. Initially penciled for closure in 2014, it is now planned to run to 2016. NHS England, the national agency that oversees the fund, has just been given a boost of a further £80m (US$133m) to the existing £200m (US$332m) a year that was already earmarked. Read More »

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Europe: More Direct-Acting Antivirals, More Controversy

The storms raging across Europe—and beyond—over the pricing of new hepatitis C treatments have been intensified by the European Union’s approval last week of the latest directly-acting antiviral, Bristol-Myers Squibb’s Daklinza (daclatasvir). Just two months after the European Medicines Agency gave a positive opinion on the drug, the formal authorization was delivered for use in combination for the treatment of chronic infection in adults.

The company will now start negotiations with each of the national pricing and reimbursement authorities in the EU countries where it wants to launch the product—and those negotiations will be conducted amid the turbulence created by arguments over the price for Gilead’s Sovaldi (sofosbuvir).

For the full Applied Clinical Trials article by Peter O’Donnell, click here.

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From the Generic to the Supergeneric Era

By Adeline Siew, Pharmaceutical Technology.

Generic drugs save patients and European healthcare systems approximately EUR 35 billion (US$46bn) each year, according to the European Generics Association (EGA). Of the 16 health-related recommendations made by the European Commission for 2014–2015 to EU member states, 11 concerned cost efficiency in the healthcare sector. But, speaking at the EGA Conference in Madrid, Spain, earlier this summer, EGA President Nick Haggar noted that  vague recommendations by the Commission would only make it difficult for member states to implement measures and monitor their progress. The Commission has recommended that France, for example, should go beyond short-term savings and tackle pharmaceutical spending over the medium to long term, but has given no specific measures to help the country achieve this objective. EGA is calling for the Commission to refer to the role played by generic drugs in adding value to patients as well as the competitiveness of the EU pharmaceutical industry.

One question, however, is whether or not the European generic drug market is sustainable, given that the blockbuster era has reached its end and the shift in the type of medicines losing patent protection in Europe over the coming years. According to the Boston Consulting Group, between 2014 and 2020, specialty drugs and biologics will make two thirds of the value of products losing patent protection in Europe. Read More »

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