United States

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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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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NIH recruits three Lasker Clinical Research Scholars

Monday, December 15, 2014 12:19 PM

The NIH has selected three researchers as new Lasker Clinical Research Scholars as part of a joint initiative with the Albert and Mary Lasker Foundation to nurture the next generation of great clinical scientists.

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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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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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Illinois Biotechnology Industry Organization adds to board of directors

Thursday, December 11, 2014 10:51 AM

The Illinois Biotechnology Industry Organization (iBIO) has elected several new additions to its board of directors. The new board members include Daniel Brennan of Lundbeck U.S., Jamie Oldani of Eli Lilly, Susanne Resatz of Vetter Development Services USA and Geeta Vemuri of Baxter Ventures.

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Vital Connect, Medidata partner on continuous vital sign monitoring

Wednesday, December 10, 2014 01:11 PM

Silicon Valley-based Vital Connect’s FDA-cleared wearable biosensor, HealthPatch MD, now is available for use in clinical trials in partnership with Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences. HealthPatch MD can be used with Medidata’s technology platform, Medidata Clinical Cloud, and its mobile app for patient-reported outcomes, Medidata Patient Cloud, to further remote patient monitoring, which has the potential to make clinical trials more efficient.

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Takeda renames Millennium as Takeda Oncology

Wednesday, December 10, 2014 01:10 PM

Takeda Pharmaceutical has announced its global oncology business unit, headquartered in Cambridge, Mass., now will be called Takeda Oncology. The creation of Takeda Oncology will improve the company's ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology R&D, while expanding its global commercial network and resources as Takeda Oncology.

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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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