Ethics/Regulatory

Rethink Research Competition opens voting for People’s Choice Award

Friday, July 24, 2015 02:28 PM

The Rethink Research Competition has opened voting for the People’s Choice Award.

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ICER launches New Drug Assessment Program with $5.2M award

Friday, July 24, 2015 09:15 AM

With drug prices for cancer and many other conditions soaring to new highs amid questions about their true value to patients, the Institute for Clinical and Economic Review (ICER) has launched a program to transform the way new drugs are evaluated and priced in the U.S.

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U.S. House passes 21st Century Cures Act

Wednesday, July 15, 2015 12:03 PM

The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA.  On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0. 

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Social media bill introduced for pharma product information

Monday, July 6, 2015 09:24 AM

U.S. Representative Billy Long has introduced legislation to update regulations guiding how drug manufacturers communicate product information.

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Schulman Associates IRB acquires Absolute Research to expand its research capabilities

Monday, July 6, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Looking to bolster its clinical research regulatory services for its institutional clients and gain eConsent technology for small to mid-size biopharmaceutical customers, Schulman Associates IRB has acquired Absolute Research, whose research and technology capabilities will be expanded.

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Astrazeneca, University of Cambridge form joint Ph.D., clinical research scholarships

Wednesday, July 1, 2015 10:11 AM

AstraZeneca and the University of Cambridge have formed three new joint schemes to support more than 80 Ph.D. scholarships and eight clinical lectureships over the next five years, spanning translational science, basic and clinical research.

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Report: Venture financing in biotech follows male CEOs and boards

Monday, June 29, 2015 10:07 AM

Gender still plays a role in biotech, with venture financing closely following male CEOs and all male boards, found Liftstream, a London-based company providing executive recruitment services to the biotechnology sector. Liftstream has published a new gender diversity report, Investing in Biotechnology Management, a study of venture financing and hiring trends in European and U.S. biotechnology companies and the gender representation on the boards and at the executive level. The research analyses 110 investment deals in private biotechnology companies as well as 308 biotech executive appointments.

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015 10:20 AM

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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CTI, Xavier University partner on new masters degree program

Monday, June 22, 2015 12:03 PM

CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service CRO, is collaborating with Cincinnati, Ohio-based Xavier University on a new Master’s program.

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Schulman IRB breaks ground on new RTP location

Friday, June 12, 2015 10:18 AM

Schulman Associates IRB, a central IRB in customer service and technology, recently began build-out of its new office space on Laboratory Drive in Research Triangle Park, Durham, N.C. The location will house review board and administrative staff, including IT, operations and customer service professionals.

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CWWeekly

July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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