Ethics/Regulatory

EMA revises policy on conflicts of interest

Friday, November 21, 2014 11:19 AM

The EMA has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the agency’s work, while maintaining EMA’s ability to access the best available expertise.

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Quest Diagnostics

EUCROF states position on new clinical trials regulation

Friday, November 14, 2014 10:48 AM

The European CRO Federation (EUCROF), which represents 300 member CROs, has released proposals on the early publication of clinical trial information, balancing the public’s need for transparency and innovators’ intellectual property and confidentiality rights.

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U.S. government institutes funding pause on gain-of-function research

Wednesday, October 29, 2014 01:39 PM

The U.S. government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS and MERS viruses in order to develop a new federal policy regarding the funding of this research, announced Francis S. Collins, M.D., Ph.D., NIH director, in a statement. U.S. government agencies will institute a pause on the funding of any new studies involving these experiments.

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Treasury’s tax inversion changes scuttle some big biopharma mergers, modify others, prompting calls for Congressional corporate tax reform

Thursday, October 23, 2014 03:50 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.

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INC Research to perform FDA due diligence audit for Provectus

Thursday, October 23, 2014 01:10 PM

Provectus Biopharmaceuticals, a Knoxville, Tenn.-based development-stage oncology and dermatology biopharmaceutical company, has retained INC Research, a Raleigh, N.C.-based global CRO, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.

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MHRA sets up ‘one-stop shop’ for advice on regenerative medicine

Thursday, October 16, 2014 08:00 AM

The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovation Office has set up a portal for all regulatory queries concerning regenerative medicines, the Regenerative Medicines Regulatory Advice Service. A “one-stop shop” service, it will provide a single point of access from the four regulators in the field: the Human Tissue Authority (HTA), the Human Fertilization and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), which will provide a coordinated single response service for free regulatory advice.

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Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

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NICE develops new guidelines for antibiotic resistance

Wednesday, October 15, 2014 01:39 PM

NICE is developing two new guidelines to help tackle the growing threat of antibiotic resistance. The first is on safe and effective antimicrobial stewardship in relation to the use of antimicrobials in health and social care, and the second is a public health guideline that will focus on changing people’s knowledge, attitudes and behaviors in relation to the use of antimicrobials.

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In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

Monday, October 13, 2014 07:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Given the choice between talking about Chesapeake Research Review, the highly successful IRB he founded in 1993, or conveying useful information and insights involving bioethics and human subject protection, Felix A. Khin-Maung-Gyi would always choose the latter.

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U.K. public believes not enough is being spent on medicines

Thursday, October 9, 2014 11:35 AM

A new survey has found more than half (52%) of English adults believe that not enough of the NHS budget is being spent on medicines. The survey was commissioned by the Association of the British Pharmaceutical Industry (ABPI), which includes research-based biopharmaceutical companies in the U.K.

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CWWeekly

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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