United States

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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PCORI, NIH request applications to study blood pressure control

Wednesday, December 10, 2014 01:05 PM

The NIH, as part of a research partnership with the Patient-Centered Outcomes Research Institute (PCORI), has issued a request for applications (RFA) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks and other cardiovascular events. PCORI is a Wash. D.C.-based independent nonprofit organization authorized by Congress.

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Medidata releases Patient Profiles consulting service

Wednesday, December 10, 2014 01:02 PM

Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, has made available its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a methodology for reducing trial costs while providing clinical data accuracy and quality.

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Health Decisions CEO Michael Rosenberg, Nuventra Pharma VP David Hartman killed in plane crash

Tuesday, December 9, 2014 12:47 PM

CRO Health Decisions, based in Durham, N.C., confirmed yesterday its founder and CEO Michael Rosenberg, M.D., MPH, died at 11 a.m. Monday in a private plane crash near Montgomery County Airpark in Gaithersburg, Md., a Washington, D.C. suburb.

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Aldeyra Therapeutics, National Organization for Rare Disorders collaborate

Monday, December 8, 2014 01:04 PM

Aldeyra Therapeutics, a Massachusetts-based biotechnology company focused on the development of products to treat diseases related to free aldehydes, is collaborating with the National Organization for Rare Disorders (NORD), a U.S. nonprofit organization dedicated to helping people with rare diseases.

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ALS Association, Muscular Dystrophy Association partner

Friday, December 5, 2014 12:33 PM

The ALS Association, a national nonprofit based in Wash. D.C., and the Muscular Dystrophy Association (MDA), a Chicago-based nonprofit health agency, have joined forces to fund a research project aimed at finding a potential therapy for amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease. Both nonprofits are focused on finding treatments and cures for ALS and providing services for those affected with the debilitating, fatal disease.  

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CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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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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