EFPIA

Da Volterra, The Medicines Company join COMBACTE-NET to combat antimicrobial resistance

Friday, November 18, 2016

The Innovative Medicines Initiative (IMI)-funded New Drugs 4 Bad Bugs (ND4BB) project COMBACTE-NET announces that two new pharmaceutical companies, Da Volterra and The Medicines Company, have joined the project as partners. Together with the existing partners the new partners will closely collaborate to further strengthen the public-private partnership aiming to combat the worldwide growing problem of antimicrobial resistance.

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Three resonating patient-centric initiatives

Friday, July 1, 2016

Sponsor companies are piloting patient-centric initiatives at a furious pace. Although few initiatives designed to engage patients as clinical research partners have achieved widespread adoption, several are making substantial inroads. In this issue, CenterWatch profiles three major patient-centric initiatives that appear to be resonating across the clinical research enterprise.

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Regulatory Update, January 2016

Friday, January 1, 2016

FDA Seeks Comments on ICH’s GCP Guideline Update

In Sept. 29’s Federal Register, the FDA announced the availability of a draft guidance titled “Guideline for Good Clinical Practice” E6 (R2). The draft is an update of the International Conference on Harmonisation’s (ICH) “Guideline for Good Clinical Practice” E6 (R1), in which new information is integrated into the original document. The changes are intended to encourage improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also to update standards regarding electronic records and essential documents. The draft also is intended to improve clinical trial quality and efficiency while maintaining human subject protection. The FDA made the draft guidance available for public comment on the sections added to ICH E6 (R1) and marked as “ADDENDUM.”

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Oschmann to chair Merck’s executive board

Wednesday, October 14, 2015

Germany-based Merck has appointed Stefan Oschmann as new chairman of the executive board and CEO. The appointment will take effect with the end of the Annual General Meeting on April 29, 2016. Oschmann will succeed Karl-Ludwig Kley, who will retire after nine years as head of Merck.

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Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

Monday, March 30, 2015

Having accurate customer reference data for all healthcare professionals, healthcare organizations and affili­ations across life sciences’ major markets—and managing it all—is a burden Veeva Systems has addressed with the launch of a new streamlined approach to deliver cus­tomer data sourced locally and consolidated into a single global reference database.

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New Innovative Medicines Initiative project launched to combat carbapenem resistance

Wednesday, March 25, 2015

Eighteen European academic partners and three pharmaceutical companies are launching a new project under the Innovative Medicines Initiative (IMI) funded New Drugs 4 Bad Bugs (ND4BB) program. COMBACTE-CARE (Combating Bacterial resistance in Europe-Carbapenem-Resistance) will bring highly innovative studies and activities related to the treatment of patients with infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE). Being very difficult to treat and sometimes deadly, CRE are considered to be one of the most dangerous resistant bacteria in the world. University Medical Center Utrecht is the project’s managing entity.

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AstraZeneca establishes scientific review board for clinical trial data transparency

Thursday, March 19, 2015

AstraZeneca has created a scientific review board that will act independently to assess requests from external researchers, which includes patient level data. The board of independent clinicians and academics has been established as part of AZ’s commitment to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) Responsible Data Sharing Principles, as well as the new EMA Clinical Trial Policy and Regulation.

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