Ethics/Regulatory

Academy of Medical Royal Colleges not supporting Medical Innovation Bill

Friday, January 23, 2015 11:43 AM

The Academy of Medical Royal Colleges has released a statement on the proposed Medical Innovation Bill.

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EMA opens public consultation on transparency rules of E.U. Clinical Trial Regulation

Thursday, January 22, 2015 12:11 PM

The public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database has been launched by the EMA. Stakeholders are invited to send their comments before Feb. 18.

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New EMA guide for implementing safety monitoring changes

Thursday, January 22, 2015 12:10 PM

The EMA has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the E.U. The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on July 1, 2016.

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Verified Clinical Trials, Quorum Review IRB collaborate to prevent dual enrollment

Monday, January 19, 2015 12:53 PM

Verified Clinical Trials and Quorum Review IRB have developed an expedited research subject authorization review process that reduces cost and time. Research sites, CROs and sponsors will benefit from this alliance in the effort to stop dual enrollment in clinical trials and reduce significant protocol deviations. 

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FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

By Ronald Rosenberg
CenterWatch Staff Writer

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

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NHS increases budget for cancer drugs fund to an expected $400M

Wednesday, January 14, 2015 12:40 PM

The NHS Cancer Drugs Fund (CDF) has published a review of drugs included in the fund and increased the budget for cancer drugs. The budget for the CDF will grow from $235 million in 2013-2014, to $329 million in 2014-2015, and an estimated $400 million from April 2015. This represents a total increase of 70% since August 2014.

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EMA recommends record number of rare disease medicines for approval in 2014

Tuesday, January 13, 2015 10:00 AM

In 2014, the EMA recommended the highest number of orphan designated medicines for marketing authorization. Out of the 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, providing therapies for patients who often have only few or no treatment options.

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U.S. immunity against legal claims given to developers of Ebola treatments

Monday, January 5, 2015 12:52 PM

Health and Human Services Secretary Sylvia M. Burwell has announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines. This declaration is intended to assist in the global community's effort to help combat the current epidemic in West Africa and help prevent future outbreaks there.

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Worldwide neuro startup challenge crowdsources 72 new contenders competing to launch new startups around unlicensed NIH inventions

Monday, December 22, 2014 02:33 PM

The largest worldwide, open innovation competition to bring promising brain-related inventions to market is crowdsourcing 72 teams participating from 80 universities, research institutes and hospitals.

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14 indicted in connection with 2012 nationwide fungal meningitis outbreak

Friday, December 19, 2014 02:29 PM

The Justice Department unsealed a 131-count criminal indictment in Boston in connection with the 2012 nationwide fungal meningitis outbreak. Barry J. Cadden, owner and head pharmacist of New England Compounding Center (NECC), and NECC’s supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.   

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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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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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