Ethics/Regulatory

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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Congress includes $25 million increase for Alzheimer’s research funding in spending bill

Monday, December 15, 2014 12:33 PM

The 2015 U.S. government spending package, known as the cromnibus, includes an increase of $25 million for the National Institute on Aging (NIA), with an expectation that much of the funding would support additional research into Alzheimer’s and dementia.

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Senators introduce bill for streamlined pathway to approval for antibiotics

Friday, December 12, 2014 03:33 PM

U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) have introduced a bill to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly Veterans who have encountered antibiotic-resistant bacteria while overseas.

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PPMD calls for greater transparency, accountability of FDA patient engagement efforts

Wednesday, December 10, 2014 01:16 PM

Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.

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CWWeekly

December 22

DaVita combines its two research CRO units to create an end-to-end CRO focused on kidney, end-stage renal disease

New crop of clinical trial matching services use patient’s molecular, genomic data for better fit

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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