Ethics/Regulatory

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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Senate Health, Human Services unanimously approve biosimilars legislation

Wednesday, June 10, 2015 11:15 AM

Legislation that allows for greater patient access to more affordable FDA-approved biologic medicines was approved unanimously by the Senate Health, Human Services and Senior Citizens Committee. The bill now moves to review by the full Senate.

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NIH suspends operations in its Clinical Center Pharmaceutical Development Section

Friday, June 5, 2015 10:55 AM

The NIH Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. FDA representatives inspected the PDS and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.

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WHO draws lessons from Ebola to prepare roadmap for future epidemics

Wednesday, May 13, 2015 12:17 PM

The World Health Organization (WHO) has concluded a meeting on Ebola R&D to look at lessons learned from the outbreak and develop a roadmap for future epidemics.

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EMA tightens rules on 'revolving door' for committee members and experts

Thursday, May 7, 2015 12:21 PM

The EMA has updated its rules on declarations of interests for scientific committee members and experts. The updates further strengthen EMA’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The updates also include a revised guide on how to complete the agency’s declaration of interest form.

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EMA scientific advice leads to higher success rates, shorter assessment times

Tuesday, April 21, 2015 07:58 AM

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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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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