Theorem Clinical Research

Ethics/Regulatory

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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Quest Diagnostics

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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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.

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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.

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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.

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2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

Wednesday, December 17, 2014 03:15 PM

Margaret A. Hamburg, M.D., commissioner of the FDA, spoke about 2014 drug approval data on the FDA’s official blog FDAVoice.

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FDA announces Pharmacy Compounding Advisory Committee members

Wednesday, December 17, 2014 12:29 PM

The FDA has announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members—12 voting and two non-voting—who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

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AiCure
CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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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

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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

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