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United States

AMRI announces lifting of FDA warning letter

Wednesday, November 13, 2013 09:27 AM

Albany, N.Y.-based Albany Molecular Research (AMRI) has received a close-out letter from the FDA lifting a 2010 warning letter related to its Burlington, Mass., aseptic fill-and-finish facility.

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CRF Health eCOA webinar series

U.S. Clinical Researchers of the Year announced

Tuesday, November 12, 2013 08:00 AM

The 2013 U.S. Clinical Researchers of the Year winners have been revealed at the Umstead Hotel in North Carolina, U.S.

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Genetic Alliance, PhRMA initiative for patient-focused drug development

Monday, November 11, 2013 02:56 PM

Genetic Alliance, a nonprofit health advocacy organization, and the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an initiative to explore the use of a technology-enabled, crowd-sourcing approach to patient engagement as a complement to ongoing patient-focused drug development efforts under the Prescription Drug User Fee Act (PDUFA V).

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Ariad reduces U.S. workforce by 40%

Friday, November 8, 2013 12:09 PM

Ariad Pharmaceuticals, headquartered in Cambridge, Mass., and Lausanne, Switzerland, is cutting approximately 40% of its staff positions in the U.S. following its decision to temporarily suspend the marketing and commercial distribution of Iclusig (ponatinib) in the U.S.

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CTCA names Giuseppe Del Priore national director, southeastern regional director

Tuesday, November 5, 2013 11:31 AM

Cancer Treatment Centers of America (CTCA) has announced the appointment of Giuseppe Del Priore, M.D., MPH as the national director of gynecologic oncology. Based out of the CTCA Southeastern Regional Medical Center in Georgia, Del Priore will oversee the organization's national gynecologic oncology practice.

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Johnson & Johnson, Janssen Pharmaceuticals, Scios finalize Risperdal settlements, will pay $2 billion

Monday, November 4, 2013 02:18 PM

Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals and Scios have finalized previously disclosed settlement agreements with the U.S. Department of Justice (DOJ) and 45 states resolving federal investigations and state Medicaid claims related to past promotional practices of Risperdal (risperidone) from 1999 through 2005, and other matters. The resolution includes total settlement amounts of approximately $2 billion to the federal government and state Medicaid programs, an amount previously accrued, and no additional charge to the company’s earnings will be recorded in connection with this settlement.

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FDA takes two actions on drug shortages

Friday, November 1, 2013 11:14 AM

The FDA is taking two actions to further enhance its ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order to reduce drug shortages, the number of new shortages in 2012 fell to 117, down from 251 in 2011. 

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Richard Segiel, Jr. joins Almac as vice president of U.S. business development

Thursday, October 31, 2013 10:00 AM

Richard Segiel, Jr. has joined Almac’s clinical services business unit as vice president of business development for the U.S. He will focus on developing new business, maintaining existing business and developing partnerships.

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Clinical Conductor CTMS, Greater Gift Initiative partner to donate vaccines

Wednesday, October 30, 2013 11:20 AM

Clinical Conductor CTMS, a clinical trial management system for research organizations from Bio-Optronics, has partnered with the Greater Gift Initiative (GGI) to donate vaccines in honor of clinical trial industry fall conference participants.

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Vertex cuts workforce 15%

Wednesday, October 30, 2013 11:12 AM

Global biotech Vertex Pharmaceuticals will focus its investment on future opportunities in cystic fibrosis and other high-potential R&D programs and is reducing its workforce related to the support of INCIVEK, because of the continued and rapid decline in the number of people being treated with INCIVEK as other new medicines for hepatitis C near approval.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly


Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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