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.

FDA official: “clinical trial system is broken” - BMJ
FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohenhow he believes the current research and development process is brokenThe clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak.For seasoned observers of the drug approval process, Marciniak will be a familiar name and his comments will come as little surprise. In his 11 years at the US federal agency, Marciniak has been embroiled in high profile controversies that have pitted...
Source: PharmaGossip - December 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

BMJ editor casts doubt on veracity of statin trials funded by the statin makers
- GodleeStatins for all over 50? NoFiona Godlee, editor, BMJBMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6412 (Published 23 October 2013) Cite this as: BMJ 2013;347:f6412 Should you prescribe statins to everyone over the age of 50, even those at low cardiovascular risk? A new Cochrane review seems to suggest that you should. An article in this week BMJ cries caution (doi:10.1136/bmj.f6123).Current guidance from the UK’s National Institute for Health and Care Excellence (...
Source: PharmaGossip - November 22, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps
PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. The acceptance of the MAA marks the beginning of the review process in the European ...
Source: Medical Hemostat - November 21, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs

EMA Clears Roche For Failing To Report Side Effects
After spending a year investigating Roche for a failure to report tens of thousands of adverse events in connection with various drugs, the European Medicines Agency has concluded its review and “has not identified any important new safety concerns.” “The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” the EMA says in a statement. The regulator adds that Roche is expected to ensure such data are included and considered in routine pharmacovigilance activities, though. The so-called “infringement procedure” was conducted by the agency’s Pha...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

EMA May Delay Finalizing Policy For Disclosing Clinical Trial Data
Last June, the European Medicines Agency released a draft proposal of a new policy concerning the release of clinical trial data (see this) and the effort quickly became controversial. Why? The EMA wants to proactively make trial data, which is submitted in connection with marketing approval for a drug, available to researchers once an approval decision has been made. The proposal has endured withering criticism. The European Federation of Pharmaceutical Industries and Associations, the industry trade group, blasted the policy and suggested the approach would weaken safeguards for protecting patient privacy, undermine trus...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Orphan Drugs - The Seattle Times explains
The mining of rare diseasesThirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.By Michael J. Berens and Ken ArmstrongHer vision failed first.Then she fell asleep at school from inexplicable fatigue. Even walking proved difficult, often impossible, as she knocked into furniture and walls. It was like an electrical switch in her body toggled without warning. Some days she was in control, most she was not.Specialists were s...
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Does Brilinta's Brilliance Beggar Belief?
The European Medicines Agency is demanding more information from AstraZeneca on its troubled heart pill Brilinta. This rounds off a tough few weeks for the firm as it comes after the US Department of Justice (DOJ) took the unusual decision to investigate the product in late October. Neither AZ nor the DOJ have disclosed the exact nature of the investigation, but analysts believe it relates to various aspects of the study that have been criticised by external researchers. This includes comments from James DiNicolantonio of Ithaca New York, and Ales Tomek of Charles University in Prague, who said in a recent paper that pa...
Source: PharmaGossip - November 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Johnson & Johnson, Risperdal And A Lack Of Clinical Trial Disclosure
In the wake of the $2.2 billion settlement that Johnson & Johnson will pay to resolve both criminal and civil charges leveled by US authorities has focused attention on off-label marketing practices and kickbacks paid to physicians and a nursing home pharmacy (back story with links). But court documents reveal another troubling issue – withholding clinical trial data. The disclosure comes amid a heated debate over the extent to which drugmakers are willing to disclose trial data. The pharmaceutical industry is, by and large, fighting a proposal by the European Medicines Agency (read here and here) as well as a separa...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

AllTrials - The Harvard Way
Report Proposes Ways to Expand Access to Clinical Trial DataResearchers from Harvard, together with members of a group created by the Multi-Regional Clinical Trials Center, released a report last week that proposed ways to expand access to clinical trial data.The report--published online in The New England Journal of Medicine--outlined the possible benefits and risks, ethical and legal issues, and logistical questions associated with expanding access to participant-level data, which have, in the past, been considered confidential by the Food and Drug Administration, which regulates clinical tr...
Source: PharmaGossip - October 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

New drug to help common bowel condition
(Medical Xpress)—An international team led by University of Adelaide researchers has discovered the mechanism of pain relief of a new drug for treating Irritable Bowel Syndrome with Constipation (IBS-C), based on nonclinical studies, and quantified its effectiveness in pain relief in human trials. Published in the journal Gastroenterology , the study details the pain mechanism of action meant for Linaclotide, a recently approved drug for the treatment of chronic abdominal pain and constipation in adult IBS-C patients. IBS is a potentially debilitating condition along with abdominal pain, bloating, ...
Source: My Irritable Bowel Syndrome Story - October 29, 2013 Category: Other Conditions Authors: Ken Tags: IBS News Source Type: blogs

Ben Goldacre writes
Dear FriendsYesterday the pharmaceutical company LEO Pharma announced its commitment to publish results of its clinical trials dating back to 1990. They are also going to provide access to anonymised patient-level data dating back to 2000 on request. Great stuff from LEO Pharma! GSK who joined the campaign in February have been sharing their approach with LEO Pharma and with other companies who are having these discussions. These companies are moving further and further away from the obfuscating attitude of the some of the industry trade bodies who seem to want to keep secrecy as the norm.Also this week...
Source: PharmaGossip - October 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

David Healy writes
October 2013 Dear Jack: Here's a recap of blog posts and other news from the past month. Thank you to everyone who signed RxISK's drug safety petitionasking pharmaceutical giants AbbVie and Intermune to stop blocking the European Medicines Agency (EMA) from releasing prescription drug clinical trial data. You are now part of a global movement with 6000+ signatures from 110+ countries. We have a brief window of opportunity before the EU judgement on EMA's data access policy to spread the message through extreme petitioning. We need your help to deliver it with style. ...
Source: PharmaGossip - October 25, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

An Independent Board To Oversee Clinical Trial Data Disclosure?
Over the past year, the heated controversy over disclosing clinical trial data has grown more heated. For instance, pharmaceutical industry trade groups have attacked a proposal by the European Medicines Agency and two drugmakers took court action to prevent the EMA from releasing data. The BMJ will no longer publish studies unless anonymized patient-level data is made available (see this). And a UK parliamentary committee criticized the government for failing to push industry harder for data (back story). Meanwhile, an aggressive online campaign called AllTrials is trying to pressure drugmakers to agree to greater disclos...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Drug industry can profit from clinical-trial data openness, say leading regulators
The drug industry’s opposition to greater access to clinical trial data is misplaced, four senior figures in the European Medicines Agency (EMA) said today.The agency is preparing to vastly expand the amount of information it makes available to researchers, and is close to finalizing a policy on making public data submitted to it by drug companies applying for licences for new medicines. Some elements of the pharmaceutical industry have fought back, complaining that this will release confidential data crucial to its interests and harm investment in the development of new drugs (see ‘Secrets of trial data revealed‘).B...
Source: PharmaGossip - October 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

LEO Pharma to release clinical trial data
Published on 24/10/13 at 03:52pmLEO Pharma has announced that it will start releasing clinical trial data from studies dating back to almost 25 years ago.The Denmark-based firm said it is using this as a “Declaration of its support for the increased global calls for transparency coming from many quarters”, which includes patient groups, researchers and think tanks.In practical terms this means that from 1 January next year researchers, patient associations and healthcare professionals can gain access to LEO Pharma’s clinical trial data as it gradually posts summary results sponsored by the firm, that date back to 24 ...
Source: PharmaGossip - October 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs