European Medicines Agency (EMA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Ben Goldacre suggests 5 things you can do today to help us with AllTrials
Dear FriendsThe head of Europe's pharmaceutical industry body has threatened "a series of lawsuits" if the EU's medicines body goes ahead with its great plans to publish more of the clinical trial information it holds. The European Medicines Agency plans to proactively publish the Clinical Study Reports (CSRs) companies submit to it when they apply for a license. Researchers at Germany's medicines licensing body this week showed that these CSRs contain vital information about drug effectiveness and safety and that regulators and doctors need that information to make decisions about treatments.The industry body th...
Source: PharmaGossip - October 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Health Policy Brief: Biosimilars
A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation explains key elements of the Biologics Price Competition and Innovation Act (BPCIA), a provision of the Affordable Care Act. The BPCIA authorizes the Food and Drug Administration (FDA) to develop an accelerated approval process for biosimilars. Biosimilars are follow-on versions of original therapies derived from a biological source, including vaccines, antitoxins, and blood products—commonly referred to as biologics. The FDA released draft guidelines for an accelerated approval process for biosimilars in February 2012, but the widespre...
Source: Health Affairs Blog - October 10, 2013 Category: Health Medicine and Bioethics Commentators Authors: Chris Fleming Tags: All Categories Biotech Business of Health Care Competition Health Law Health Reform Innovation Pharma States Source Type: blogs

EMA told: conflict of interest is "a threat to patient health"
By LYNNE TAYLOR There is “overwhelming evidence" that any conflict of interest in the scientific review progress “is a threat to patient health,” the European Medicines Agency has been told. Therefore, the Agency should rely on internal staff and experts with no links to industry to deliver scientific assessments, Pierre Chirac, editor of the French Revue Prescrire, has told a workshop organised by the EMA to discuss its policy on conflicts of interests for experts. “Scientists cannot be independent from the sponsor if they are under pressure to publish or perish,” said Mr Chirac. The EMA currently has arou...
Source: PharmaGossip - October 4, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

FDA-EMA Meeting on Orphan Drug Development: Offers Overview of Program and One on One Sessions with Product Developers
The Food and Drug Administration (FDA) recently announced its Office of Orphan Products Development will be holding a meeting entitled "The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop." The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product ("drug") to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ...
Source: Policy and Medicine - October 1, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

AllTrials response to EMA consultation on access to clinical trial data
27th September 2013It’s important that the European Medicines Agency hears from lots of different voices in support of their good proposals on sharing clinical trial data. So please send them something, even something short. Below is the summary of our response. Please feel free to borrow from this for your response. Remember that the deadline for responses is this Monday 30th September 2013. Read the EMA’s policy paper and how to respond to it here.The AllTrials campaign is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sens...
Source: PharmaGossip - September 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

David Healy appeals
Two years ago, the European Ombudsman ruled that the European Medicines Agency should open up access to Clinical Trial Data for anyone who applied from anywhere in the world. Six months ago two US pharmaceutical companies AbbVie and InterMune took a legal action against EMA that has closed down access to all trial data for all drugs for all doctors and researchers anywhere in the world.. Most people have not heard of AbbVie. Until recently they were Abbott Laboratories, one of the biggest pharmaceutical companies in the world. They make Humira, a monoclonal antibody used for Rheumatoid Arthritis, Croh...
Source: PharmaGossip - September 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

UK government 'must push for clinical trial transparency' - MP committee calls for publication of results from clinical trials using NHS treatments
All clinical trials conducted on treatments made available under the NHS in the UK should be registered and their results published, according to MPs. The Commons' Science and Technology Committee said the government has not been doing enough on trial transparency; a situation which is "undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk", according to committee chair Andrew Miller. The report warns that unfavourable results from clinical trials are often going unpublished and many trials are not registered before they are carried out, with researchers in both indust...
Source: PharmaGossip - September 17, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Petition by Professor David Healy - please sign if you agree
Let us see Drug Data! Drug hazards are not “trade secrets”!Drug companies maximize the sales of new drugs by hyping their benefits while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in Europe – a development hailed by American, and European researchers and researchers around the world as a major step towards drug safety.This process has been shut down by a lawsuit taken by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 bil...
Source: PharmaGossip - September 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"
Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a righteously angry post in support of transparent clinical research. As we have noted frequently, clinical trials done on human subjects are often manipulated to increase the likelihood of results favorable to commercial sponsors, or suppressed when even such manipulation does not produce the desired results.Note that such suppression and manipulation degrade the scientific value of the studies, impede the evidence-based medicine process to rationally apply clinical research evidence to improve the health of patients and the public, and violate the trust of ...
Source: Health Care Renewal - September 12, 2013 Category: Health Medicine and Bioethics Commentators Tags: secrecy deception Abbott InterMune AbbeVie mission-hostile management suppression of medical research Source Type: blogs

Pharma Blasts EMA Draft Policy On Disclosing Clinical Trial Data
In the latest bid to thwart the European Medicines Agency from proceeding with a new policy for disclosing clinical trial data, the pharmaceutical industry has openly challenged the effort by arguing the suggested approach would weaken safeguards for protecting patient privacy, undermine trust in the regulatory system, increase the risk data would be misinterpreted and weaken incentives for research. The European Federation of Pharmaceutical Industries and Associations “has serious concerns about the EMA draft policy, which carries negative implications for public health in its failure to adequately protect the interests...
Source: Pharmalot - September 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Health experts critical of pharma industry's new transparency rules
The European pharmaceutical industry association EFPIA has published new ethical commitments on clinical trials aimed at allaying accusations that a lack of transparency on how new drugs are tested is hurting patients. Critics however are unconvinced. Speaking on Tuesday (27 August), the director of EFPIA, Richard Bergström, said the industry's new ethical commitments were aimed at preventing public health problems down the line. The commitments include improving data sharing with researchers, enhancing public access to clinical study information, sharing results with patients who participate in clinical trials...
Source: PharmaGossip - August 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Diabetes Drugs Pancreatic Cancer Risk Not Backed By Existing Evidence: FDA
In yet another boost to several large drugmakers, the FDA has decided that there is no evidence that to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer, an FDA spokeswoman says. The decision comes several days after the European Medicines Agency reached the same conclusion (here is the EMA statement). “The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the exten...
Source: Pharmalot - July 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Sharing data from clinical trials: where we are and what lies ahead -BMJ
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4794 (Published 30 July 2013)Cite this as: BMJ 2013;347:f4794Elizabeth Loder, associate editorAuthor Affiliationseloder@bmj.comThe drive to make clinical trial data more accessible has garnered widespread international support, but rearguard actions by the drug industry could delay substantial change. Elizabeth Loder looks at international developments in the sharing of clinical trial dataAlmost a decade ago an Italian scientist, Alessandro Liberati, wrote an impassioned Personal View in the BMJ. He had developed myeloma and need...
Source: PharmaGossip - July 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

EMA Decides No Risk Of Pancreatic Cancer With Diabetes Drugs
In a decision that is a big boost to several drugmakers, the European Medicines Agency has concluded that there is no evidence to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The review took place in response to a ruckus caused by a study published in Diabetes four months ago that found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. The researchers examined the pancreas of 20 deceased human organ donors with type 2 diabetes (here is the abstract). However...
Source: Pharmalot - July 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

More Behind-the-Scenes Maneuvering. How Wonderful.
This is exactly the kind of headline the drug industry does not need. Via FierceBiotech, here's a story in The Guardian on the recent efforts to get companies to disclose more about the clinical trial results for investigational drugs. GSK is the company that seems to have done the most in this regard, but the European Medicines Agency (EMA) is proposing mandatory disclosure of trial results into a public database. That's a lot further than most companies are willing to go - so what to do? The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European...
Source: In the Pipeline - July 26, 2013 Category: Chemists Tags: Why Everyone Loves Us Source Type: blogs