EMA

START expands with phase I center in Shanghai

Thursday, September 22, 2011 10:45 AM

South Texas Accelerated Research Therapeutics (START), a US-based group that claims to run the world’s largest co-ordinated network of phase I clinical trials in oncology, has opened a phase I research facility in China at Fudan University Shanghai Cancer Centre, the city’s largest cancer hospital, according to PharmaTimes.

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Hematech cuts 18 jobs in Sioux Falls facility

Tuesday, September 20, 2011 10:50 AM

Hematech, a Sioux Falls' flagship biotechnology research company, has laid off 18 people in response to the changing needs of its parent company, according to ArgusLeader.

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EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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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 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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