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.

Addressing Generic Drug Unaffordability And Shortages By Globalizing The Market For Old Drugs
Dramatic increases in the price of generic drugs have focused the attention of policymakers and the public on the limitations of marketplace economics as a means of managing drug costs and access. In recent years, prices have increased sharply for established products that have been in use for 50 years or more. These include colchicine for gout (50-fold), digoxin for heart failure (6-fold), and isoproterenol for heart rhythm abnormalities (5-fold). In one prominent example, Turing Pharmaceutical raised the cost of pyrimethamine (Daraprim), a 62-year old treatment for toxoplasmosis by over 5,000 percent, from $13 to $750 pe...
Source: Health Affairs Blog - February 23, 2016 Category: Health Management Authors: Alfred Engelberg, Jerry Avorn and Aaron Kesselheim Tags: Costs and Spending Drugs and Medical Technology Health Policy Lab Payment Policy Public Health Big Pharma Daraprim generic drugs Hatch-Waxman Act Turing Pharmaceuticals Source Type: blogs

European Medicines Agency: Framework for Interaction with Industry
The European Medicines Agency's (EMA) Management Board has adopted a new framework to govern interaction between the Agency and industry stakeholders. The framework covers interactions involving human and veterinary medicine, however there are still unanswered questions about specific products and procedures that will be resolved by internal EMA departments. The adopted framework seeks to facilitate and streamline communication, structure interactions, increase accountability and transparency, and includes a plan to monitor and report on interactions. According to the EMA's minutes, comments by the European Commission on...
Source: Policy and Medicine - February 2, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Health Policy Brief: Transparency In Clinical Research
A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) examines past and present initiatives to improve the use of clinical research for patients, providers, and health systems. According to one estimate, up to half of all completed clinical trials have never had their results published — especially those that did not have positive findings. Furthermore, a significant percentage of trials used by drug companies to support their approval applications to the Food and Drug Administration (FDA) were not made publicly available. Some companies have failed to adequately report study findings t...
Source: Health Affairs Blog - January 18, 2016 Category: Health Management Authors: Tracy Gnadinger Tags: Elsewhere@ Health Affairs Source Type: blogs

EMA Announces Publication of Clinical Trial Reports By Middle of 2016
The European Medicines Agency (EMA) announced it is moving forward with its plan to release the clinical data used in marketing authorization applications, following consultation and deliberations. A few months prior to that, around April 2014, the European Parliament passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, overwhelmingly repealing Directive 2001/20/EC. In a move toward full transparency, European regulators will soon publish clinical trial reports on all drugs approved for marketing in the European Union (EU). The policy, which was approved in principle on June 12 by t...
Source: Policy and Medicine - October 21, 2015 Category: American Health Authors: Policy and Medicine Writing Staff Source Type: blogs

Senators Press FDA Over Biosimilars Implementation
Conclusion Overall, Dr. Woodcock and the FDA will continue working on affirming the scientific framework and the efficacy of the fifty-seven products they are currently working on, in addition to creating guidelines pharmaceutical companies can refer to in creating biosimilars of their own. Dr. Woodcock hopes to have other draft guidances out regarding the naming and interchangeability within the next six months. View Woodcock's testimony here. (Source: Policy and Medicine)
Source: Policy and Medicine - September 25, 2015 Category: American Health Authors: Policy and Medicine Writing Staff Source Type: blogs

Identifying search terms
For any literature search, you will need to identify your search terms. What words or phrases are you going to search for? What thesaurus terms are you going to choose? If you are doing a detailed search for evidence for a systematic review, or doing a systematic search for some other reason, identification of search terms will include identification of synonyms, that is, alternative terms for the concept you are interested in.Here are some possible ways to identify thesaurus and free text terms, and synonyms. Scoping searchUse a PICO grid or similar to identify the search concepts, and search for those...
Source: Browsing - August 4, 2015 Category: Databases & Libraries Tags: literature searching systematic reviews Source Type: blogs

Serious Risks And Few New Benefits From FDA-Approved Drugs
Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices. But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations. This epidemic of harm from medications makes our prescription d...
Source: Health Affairs Blog - July 6, 2015 Category: Health Management Authors: Donald W. Light Tags: Costs and Spending Drugs and Medical Technology Equity and Disparities Health Policy Lab Public Health adverse drug events FDA hospitalizations Patient Safety prescriptions Source Type: blogs

Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial reporting: betraying trial participants, harming patients
Reporting biases found in trials of cardiovascular devicesReporting biases in published trials were first identified in 1986.1 Published randomized studies of combination chemotherapy compared with treatment with an alkylating agent as first line treatment for ovarian cancer showed a significant survival advantage for combination chemotherapy. Unpublished cancer trial registry data from the same studies, however, showed no such advantage.2 Similarly, in the treatment of multiple myeloma, registry data suggested a smaller survival advantage for combination chemotherapy (over prednisone and an alkylating agent) tha...
Source: PharmaGossip - June 11, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs

Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial reporting: betraying trial participants, harming patients
Reporting biases found in trials of cardiovascular devicesReporting biases in published trials were first identified in 1986.1 Published randomized studies of combination chemotherapy compared with treatment with an alkylating agent as first line treatment for ovarian cancer showed a significant survival advantage for combination chemotherapy. Unpublished cancer trial registry data from the same studies, however, showed no such advantage.2 Similarly, in the treatment of multiple myeloma, registry data suggested a smaller survival advantage for combination chemotherapy (over prednisone and an alkylating agent) tha...
Source: PharmaGossip - June 10, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs

Sidney Wolfe writes in the BMJ - AllTrials - Selective clinical trial reporting: betraying trial participants, harming patients
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Source: PharmaGossip - June 10, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs

FDA Accepts Apotex's Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to help cancer patients taking chemotherapy to fight infections and fever by boosting white blood cell count. This is the fifth application submitted through the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), and the second biosimilar submitted by Apotex. This latest Neupogen biosimilar application is not...
Source: Policy and Medicine - February 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

FDA Approves 41 New Medicines in 2014, the Most Since 1996
The Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since 1996, when the agency approved a record 53. FDA approved 27 in 2013. The jump can be attributed to many new drugs for orphan diseases, which are rare conditions and disorders that affect fewer than 200,000 people in the U.S. The spike in approvals is notable for a number of reasons. For one, the pharmaceutical industry as a whole has been bouncing back from a number of patent losses on big name products over the last couple of years—the so-called patent cliff. While a number of large companies indeed will face stiff generic co...
Source: Policy and Medicine - January 5, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

European Review Confirms Increased Risk with Ivabradine
Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug is not available in the U.S. but is under development by Amgen for the indication of heart failure. … Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - November 24, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics Amgen CHMP EMA ivabradine Servier Source Type: blogs

Physician Payments Sunshine: Minnesota Releases Transparency Template
As the federal Sunshine Act has rolled out over the last year, Minnesota has been one of the few states that has added additional reporting requirements for drug (not device) manufacturers to track. By May 1, 2015, drug manufacturers must report on their 2014 transfers of value made to physician assistants, APRNs, dental therapists, and veterinarians. These entities are excluded from the Federal reporting obligations. This week, Minnesota has released its reporting payment template. Downloadable spreadsheet to report payments to practitioners calendar year 2014. The reportable elements include: First and Last Name ...
Source: Policy and Medicine - November 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs