Theorem Clinical Research

Ethics/Regulatory

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. 

More... »

Quest Diagnostics

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.

More... »


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.

More... »

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.

More... »

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.

More... »

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.

More... »

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.   

More... »

Seven more research organizations earn AAHRPP accreditation

Friday, December 19, 2014 01:02 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited seven more organizations: four in the U.S. and three in Asia, including the first organization in Thailand.

More... »

New FDA-sponsored research: National and international device registries needed

Thursday, December 18, 2014 11:23 AM

Most Americans will be exposed to a medical device during their lives and tens of millions will receive an implantable device. However, public health and regulatory agencies in the U.S. and internationally acknowledge there are gaps both in the ability to track these devices and to provide the public the accurate, evidence-based information consumers need to improve their health and make informed care decisions.

More... »

Research, generic/biosimilar industries call for integrated strategy for Europe

Thursday, December 18, 2014 11:14 AM

Ahead of the adoption of the European Commission Work Program, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic Medicines Association (EGA) have reiterated their joint Europe 2020 strategy submission for an industrial policy for the globalization era and the value it places in the pharmaceutical sector. The joint submission highlights key proposals on how to successfully integrate the pharmaceutical sector for an industrial policy that will boost European health and wealth alike.

More... »

AiCure
CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

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

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs