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Concerned Pharmacists Sign the AllTrials petition
From Mrs A. E. Bithell, MRPharmS, and others We write as concerned pharmacists about the issue of missing clinical trial data. The effectiveness and safety of medicines is of interest to all pharmacists in all sectors of the profession. Unpublished clinical trials skew the evidence base on which their harms and benefits can be assessed, and ultimately lead to patient harm and wasted health resources. How can pharmacists advise others on the safe and effective use of medicines, or prescribe them, when the sources of information we use have not assessed the entirety of the evidence? It has been estimated that around half ...
Source: PharmaGossip - February 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Mipomersen Approved (Bonus Antisense Roundup Included)
So Isis and their partner Sanofi have received FDA approval for mipomersen (branded as Kynamro). Late last year, the European Medicines Agency turned them down, which has people wondering about the drug's future, but here they are, albeit with a warning on the label about liver toxicity. Mipomersen is designed to lower the Apo-B lipoprotein in people with the most severe (homozygous) form of familial hypercholesterolemia. That's a small patient population, but they're definitely in need of help. The really significant thing about this approval, in my mind, is that it's a pure antisense therapy, and it comes about twenty y...
Source: In the Pipeline - January 31, 2013 Category: Chemists Tags: Clinical Trials Source Type: blogs

French Regulators Pull Bayer Acne Drug Over Deaths
Two days after launching an investigation into four deaths linked to the Diane-35 acne medicine sold by Bayer, which is also prescribed as a contraceptive, French authorities have halted the sale of the drug. More than 300,000 women are using the drug for contraception, according to the National Agency for the Safety of Drugs and Health Products. The deaths were attributed to venous thrombosis, a risk that has been noted with the drug and an issue that prompted French authorities to ask the European Medicines Agency to change prescribing guidelines for third- and fourth-generation oral contraceptives after the drugs were f...
Source: Pharmalot - January 30, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Acne Bayer Contraceptives Diane-35 Mediator Servier Source Type: blogs

Avandia - the battle continues
Families face battle with GSK over dangerous diabetes drug Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US. The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems. A scientist with the Food and Drug Administration estimated that Avandia could have been respon...
Source: PharmaGossip - January 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Voluntary Industry Code For Releasing Trial Data?
In the latest move to pressure the pharmaceutical industry to release clinical trial data, the Health Committee at the UK’s National Institute for Health and Clinical Excellence has issued a report calling for drugmakers to place all information in “the public domain” and create a voluntary code for publicly releasing trial data for drugs once they have been reviewed and made available for clinical use. “The committee believes there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data about the efficacy and s...
Source: Pharmalot - January 18, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia BMJ Clinical Trial Data GlaxoSmithKline Roche Tamiflu Source Type: blogs

More from AllTrials http://www.alltrials.net/
'Misled' trial participants rage over lack of transparency As the debate about publishing raw data from trials continues to heat up, some 53 participants from clinical studies have written to the European Medicines Agency claiming that the lack of regulations requiring full publication is "a betrayal of our trust". The letter, addressed to EMA executive director Guido Rasi, notes that the participants, some healthy and some with medical conditions. all agreed to take part in studies "in the belief that we were helping to improve knowledge and treatments. We now understand that many participants in trials have been misled...
Source: PharmaGossip - January 18, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Tredaptive RIP
Niacin/laropiprant products to be suspended worldwide Tuesday 15th January 2013 LATEST NEWS The European Medicines Agency (EMA) has recommended that the marketing, supply, and authorisations of three identical niacin/laropiprant products—Tredaptive, Pelzont, and Trevaclyn—for the treatment of adults with dyslipidemia be suspended across the European Union.[1] In addition, the company that markets the combination, Merck, has begun working with regulatory agencies in all countries where the medicine is currently available to develop communications for healthcare providers and to suspend the availability of the pro...
Source: PharmaGossip - January 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Let's have a heated debate - Feb 5th , Conway Hall, London
Event Details PHARMABATE Author, doctor and academic Ben Goldacre accuses the pharmaceutical industry of 'misleading doctors and harming patients' by hiding results of clinical trials. Should transparency be a legal obligation? Where do the regulators stand on this issue? Is the current process morally acceptable or should it be changed? Decide for yourself! Come and hear an informative, balanced and lively debate. Dr Miran Epstein will discuss the disturbing relationship between the pharmaceutical industry and research ethics and explain how they can be fixed. Industry leader Chris Walker will explain how t...
Source: PharmaGossip - January 5, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Euro-Vigilance
Drugmakers must begin using a new centralized database for product safety update reports by mid-2016, the European Medicines Agency says. The updated repository will also link the PSUR single assessment procedure number with products, making searches easier, and will allow for an automated two-way exchange between national authorities’ IT systems and the PSUR repository. With FDA? (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs