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HHS, NIH to enhance transparency of clinical trial results

Friday, November 21, 2014 11:31 AM

The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to reporting requirements for clinical trials subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

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U.K. launches Innovative Medicines Review

Friday, November 21, 2014 11:27 AM

The U.K. government is launching an Innovative Medicines Review, which will consider how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics.

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Australia, New Zealand cancel agreement for joint therapeutic regulator

Friday, November 21, 2014 11:21 AM

Peter Dutton, MP, Minister for Health for Australia, and the Jonathan Coleman, Minister of Health for New Zealand, have announced their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

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OncoSec Medical, University of Washington ink research agreement

Friday, November 21, 2014 11:20 AM

OncoSec Medical, a San Diego-based company developing DNA-based intratumoral cancer immunotherapies, has entered a sponsored research agreement (SRA) with the University of Washington to evaluate the immunologic mechanisms of intratumoral DNA IL-12 electroporation.

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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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Apellis Pharmaceuticals to acquire Potentia Pharmaceuticals

Friday, November 21, 2014 11:18 AM

Apellis Pharmaceuticals, a Crestwood, Ky.-based, clinical stage immunotherapy company, will acquire Potentia Pharmaceuticals, an early stage biotechnology company also located in Crestwood. Apellis obtained the necessary intellectual property rights to develop its complement inhibitor drug compound (APL-2) in ophthalmology and plans its first clinical trial in dry age-related macular degeneration (dry AMD).

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Shire to relocate 500 jobs, U.S. headquarters, to Massachusetts

Thursday, November 20, 2014 01:43 PM

Shire plans to relocate over 500 positions to Massachusetts from its Chesterbrook, Pa., site and establish Lexington, Mass., as the company’s U.S. operational headquarters. The transition is a continuation of the company’s “One Shire” efficiency program and will streamline business globally through two principal locations—Massachusetts and Switzerland—with support from a limited number of regional and country-based offices around the world.

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Study: global spending on medicines to increase 30% by 2018, to $1.3 trillion

Thursday, November 20, 2014 01:38 PM

More specialty drug innovation, greater patient access to medicines and reduced impact from patent expiries will be the primary drivers of an increase in global medicine spending of up to 30% by 2018.

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Altasciences expands to U.S., launches Algorithme Pharma USA

Thursday, November 20, 2014 01:36 PM

Altasciences has opened Algorithme Pharma USA, further expanding the company’s North American footprint and ability to provide comprehensive bioequivalence and phase I/IIa clinical drug development capabilities in the U.S.

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Omeros reports positive data for OMS721 for thrombotic microangiopathy

Thursday, November 20, 2014 01:29 PM

Omeros has announced positive data using OMS721, the lead human monoclonal antibody for its mannan-binding lectin-associated serine protease-2 (MASP-2) program, to inhibit thrombus formation in an ex vivo pathophysiologic system of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA).

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CWWeekly

November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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