United States

Catalent Biologics opens new single-use biomanufacturing Center of Excellence

Monday, April 29, 2013 01:58 PM

Catalent Pharma Solutions, a provider of drug and biologic development services, has officially open its new, state-of-the-art biomanufacturing Center of Excellence in Madison, Wisc.

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ImageIQ, IMARC Research form co-marketing partnership

Monday, April 29, 2013 09:40 AM

ImageIQ, an imaging CRO based in Cleveland, Ohio, and IMARC Research, a Strongsville, Ohio-based CRO offering monitoring, auditing and training services, have formed a partnership that will strengthen the abilities of both organization’s clients to manage the complexities of imaging within clinical trials, and to enhance FDA approvals by ensuring that scientific data is optimized and that processes are compliant.

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Halozyme initiates randomized phase II trial of PEGPH20 in pancreatic cancer

Thursday, April 25, 2013 08:00 AM

Halozyme Therapeutics, a San Diego-based biopharmaceutical company, initiated a phase II multicenter, randomized clinical trial evaluating PEGPH20, a proprietary, investigational drug as a first-line therapy for patients with stage IV metastatic pancreatic cancer.

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AUA co-sponsoring public FDA workshops

Wednesday, April 24, 2013 11:58 AM

The American Urological Association (AUA) will co-host two FDA public workshops to address research in the areas of bladder and prostate cancer. The events, free and open to the public, will take place in San Diego on May 5 and May 6, during the AUA's annual scientific meeting.

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PRA Program to create clinical research jobs for new graduates

Wednesday, April 24, 2013 09:23 AM

PRA, a global CRO, has received a $400,000 grant from the Kansas Bioscience Authority (KBA) to create 80 new jobs this year in Kansas. The graduates will be part of the PRA (Preparing for Research Advancement) Program, an innovative career opportunity for new college graduates interested in clinical research and the CRO industry.

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Quintiles selects BRANY as U.S. Prime site

Monday, April 22, 2013 11:48 AM

BRANY (Biomedical Research Alliance of New York) has been designated a Quintiles Prime Site. The designation will advance BRANY’s participation in clinical trials by providing improved access to new industry-sponsored clinical trials.

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FDA to hold meeting on “serious disease” chronic fatigue syndrome

Monday, April 22, 2013 11:19 AM

The FDA will hold a first-ever public workshop on April 25-26, 2013, to discuss how best to facilitate and expedite the development of safe, effective drug therapies to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The workshop is open to pharmaceutical companies, researchers, clinicians and patients, and it will be live-streamed online.

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Pfizer’s palbociclib gets FDA breakthrough label

Friday, April 12, 2013 02:37 PM

Pfizer’s investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the FDA for the potential treatment of patients with breast cancer.

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Lynn Kramer appointed chief clinical officer of Eisai Product Creation Systems

Friday, April 12, 2013 02:13 PM

Eisai has appointed Lynn Kramer, MD, to the newly created position of chief clinical officer of Eisai Product Creation Systems.

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FDA requests $4.7B budget to ensure safety of food supply, modernize medical product safety

Friday, April 12, 2013 11:41 AM

The FDA is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94% of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

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