United States

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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FDA approves Blincyto (Blinatumomab) for leukemia

Thursday, December 4, 2014 02:20 PM

The FDA has granted approval of Amgen’s Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval.

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Robert Blum receives 2014 Lou Gehrig Iron Horse Award

Thursday, December 4, 2014 02:14 PM

Cytokinetics has announced that the company's president and CEO, Robert Blum, received the 2014 Lou Gehrig Iron Horse Award from ALS Therapy Development Institute (ALS.net).

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First MS patients in the U.S. receive Genzyme’s Lemtrada following FDA approval

Thursday, December 4, 2014 01:43 PM

Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

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Catalent, Valerion collaborate on orphan genetic disorder treatments

Thursday, December 4, 2014 12:32 PM

Catalent Pharma Solutions, a Somerset, N.J.-based global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, is collaborating with Valerion Therapeutics, a Concord, Mass.-based emerging science-driven company focused on the development of bio-therapeutics for orphan genetic diseases, to develop Valerion's two lead product candidates.

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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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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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