European Medicines Agency

EMA: Small, medium enterprises see consistent improvement in drug approvals

Friday, March 1, 2013 02:39 PM

Micro, small and medium-sized enterprises (SMEs) registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorization applications (MAAs) over the past seven years, according to the SME offices’s 2012 annual report.

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European Medicines Agency to focus on efficiency, transparency in 2013

Thursday, January 10, 2013 02:21 PM

The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.

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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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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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