EMA

Report: EMA’s system of comparing drugs is flawed

Friday, September 9, 2011 11:52 AM

The European system of comparing drugs against placebo and not against a comparator is flawed, according to researchers at the London School of Economics, reported InPharm.

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FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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Critics raise concerns over research, incentives of European pediatric exclusivity regulations

Monday, August 1, 2011 08:00 AM

Regulations introduced four years ago in Europe to encourage research into medicines for children have lead to important therapeutic breakthroughs for pediatric patients.  Yet concerns also have been raised about how well the system works.

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EMA recommends INCIVO for hepatitis C virus

Friday, July 29, 2011 10:25 AM

Tibotec Virco-Virology BVBA, part of Janssen Pharmaceutical, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.

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FDA, EMA reviewing Sanofi’s Multaq

Monday, July 25, 2011 01:54 PM

U.S. drug regulators are reviewing data from a halted clinical trial of Sanofi's key heart drug Multaq to determine how it may affect patients taking it for approved indications, according to Reuters.

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Aeterna Zentaris to present phase II AEZS-108 results

Wednesday, July 20, 2011 11:25 AM

Aeterna Zentaris will present the final phase II  results in endometrial cancer on its anticancer compound, AEZS-108, during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological  Oncology ("ESGO"), Sept. 11-14 in Milan, Italy.

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EMA releases paper on biomarker use for comment

Thursday, July 14, 2011 12:43 PM

The European Medicines Agency (EMA) has put out for consultation a reflection paper on the use of pharmacogenomic biomarkers as patient selection and treatment stratification tools in drug development, according to PharmaTimes.

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EMA to release monthly adverse event reports

Wednesday, July 13, 2011 10:08 AM

The EMA will start producing monthly adverse event reports for the public as part of its plans to open up access to drug information, according to InPharm.

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Tarsa to advance clinical programs with $24.5M financing

Wednesday, July 13, 2011 10:02 AM

Tarsa Therapeutics reported progress in its two ongoing clinical development programs for its oral recombinant salmon calcitonin for the treatment and prevention of postmenopausal osteoporosis. Patient enrollment in the phase II osteoporosis prevention trial has been completed, and the full set of data from the phase III ORACAL trial has been accepted for an oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2011 annual meeting in September. Separately, Tarsa also said it has closed an additional financing round that raised a total of $24.5 million.

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Examination of cancer drug approvals shows FDA is faster than EMA, disproving an ‘urban myth’

Monday, July 11, 2011 08:00 AM

It has been a long-held belief that European regulators are willing to take more innovative approaches to ushering drugs through the regulatory process. And several recent reports have criticized the FDA for being inefficient in its approval process for medical devices compared to the European Medicines Agency (EMA). Complaints about cancer drugs being held up in the U.S. regulatory process are particularly widespread.

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