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EMA launches consultation on clinical trials

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The EMA is asking companies and stakeholders if the proposal meets requirements

The European Medicines Agency has invited pharma to comment on its proposals to ramp up transparency in the industry and force companies to publish the results of clinical trials.

The EU Clinical Trial Regulation was voted into law in April 2014 and states that information from clinical trials should generally not be considered commercially confidential.

Sharing trial data should be ‘expected norm’ says US think-tank

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The report notes that despite the objections from industry and lobbyists, there are 'compelling justifications for sharing clinical trial data'

Clinical trial data is in the public interest and should be shared no less than 30 days following regulatory approval according to the Institute of Medicine, a policy advisor to the US government.

The committee producing the report that was sponsored by the FDA, the National Institutes of Health, public sector organisations and 17 pharma companies – was tasked with develop guiding principles and a framework for how pharma companies can responsibly share their clinical trial data.

EMA responds to redaction concerns

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The EMA has published a response to European Ombudsman Emily O’Reilly’s questions about some of its trial data redactions.

O’Reilly’s concerns related to redactions made to data the European regulator released for AbbVie’s arthritis treatment Humira (adalimumab).

Janssen: why transparency is essential to the health of our industry

Jane Griffiths, company group chairman for Janssen EMEA and chairwoman of the EF
Jane Griffiths, company group chairman for Janssen EMEA and chairwoman of the EFPIA

The pharmaceutical industry is moving forward, working together to ensure patients have access to new and innovative medicines.

However, more must be done to meet society’s huge unmet medical need and to enhance society’s perception of the value we bring. We need to live up to the high standards we have set ourselves. 

Despite the great value that pharmaceutical companies bring to public health and individual patients, as well as the contribution they make to the European economy, the reputation and perception of the industry as a whole has long been an issue. 

Publish all clinical trials, say pharma doctors

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Unpublished clinical trials risk the possibility of research then being repeated unnecessarily

All clinical trials should be registered and published according to a recent survey conducted by the Faculty of Pharmaceutical Medicine.

Out of the 400 Faculty of Pharmaceutical Medicine (FPM) members asked, nearly all (95%) suggested that trials should be registered, with 73% stating that clinical trials should be published within one to two years of completion.

The FPM, a part of the Royal College of Physicians, is made of doctors who hold a Diploma in Pharmaceutical Medicine. 

EMA delays trial transparency – again

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EMA headquarters

The European Medicines Agency has once again said that it is to delay the launch of its new clinical trial transparency policy – this time until October.

The European regulator says that the suspension is due to the need for “further discussion required on wording and practical arrangements”.

EMA changes ‘on screen’ data policy

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The European Medicines Agency is to formally agree its policy on the vexed issue of the publication of clinical trial data, including what it calls ‘more user-friendly amendments’.

In essence, this means that there will be “the possibility to download, save and print the trial data for academic and non-commercial research purposes”.

InterMune drops EMA lawsuit over data release

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InterMune filed an injunction against the EMA for allowing third party access to Esbriet

InterMune has ended a year-long legal spat with the European Medicines Agency over the potential release of data for its lung drug Esbriet.

The specialist firm had last year filed an injunction against the EU drugs regulator from allowing third party access to its biggest earner. 

Lilly the latest to open up data

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Eli Lilly is to begin sharing its clinical trial data with scientific researchers through a website housing information from several companies.

Access to the portal will only be granted after approval of a research proposal by an independent scientific review panel – a decision in which Lilly says it will not be involved.

NICE chair: pharma must show how it prices drugs

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Professor David Haslam (Credit: Financial Times Live)

The pharmaceutical industry must be willing to show the public how it prices its drugs - or face losing its trust.

This is according to the chairman of NICE Professor David Haslam, who tells Pharmafile that currently no one outside the boardroom of a pharma firm knows how it evaluates a drug’s worth.

“If we could have greater transparency about pricing, then a lot of problems could be bypassed - it’s not just that drugs are expensive and NICE says no, it’s about the cost-effectiveness of
these medicines. 

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