FDA

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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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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Infraredx, Massachusetts General Hospital collaborate on cardiovascular imaging devices

Wednesday, December 17, 2014 12:26 PM

Infraredx, a Burlington, Mass.-based cardiovascular imaging company, is collaborating with Massachusetts General Hospital (MGH) and coronary imaging researcher Gary Tearney, M.D., Ph.D., professor of pathology at Harvard Medical School, Mike and Sue Hazard Family MGH Research Scholar and founder of the Tearney Lab at the Wellman Center for Photomedicine at MGH. The multi-year collaboration will focus on research and development of new and combination technologies that aim to provide enhanced information about coronary disease in patients.

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FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer

Monday, December 15, 2014 12:50 PM

The FDA has expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

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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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ADDF, Alzheimer's Society U.K. to test erectile dysfunction drug as dementia treatment

Friday, December 12, 2014 03:17 PM

The Alzheimer's Drug Discovery Foundation (ADDF), based in New York, and the Alzheimer's Society U.K. have announced new funding to explore the possibility of using a commonly prescribed drug which treats erectile dysfunction as the next treatment for dementia. Tadalafil—part of the same class of drugs as Viagra—is to be one of the major research programs funded by the two charities in a cross-Atlantic research partnership. This is the first ever study researching the use of an erectile dysfunction drug for vascular dementia.

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Amgen initiates trial of Talimogene Laherparepvec and Merck's Keytruda

Thursday, December 11, 2014 01:46 PM

Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck's FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.

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Neurocrine Biosciences expands clinical pipeline

Thursday, December 11, 2014 01:12 PM

Neurocrine Biosciences has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has entered clinical trials for the treatment of classic congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the U.S. The company has successfully completed a pilot clinical trial in adults with classic CAH and is initiating an open-label, single ascending dose trial in approximately 15 adolescent females with classic CAH, the 1401 Study.

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FDA expands Gardasil 9 approval

Thursday, December 11, 2014 01:07 PM

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

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CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

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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The CenterWatch Monthly

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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