United States

SRI International completes R&D facility expansion

Friday, October 25, 2013 11:43 AM

SRI International has completed the final stage of expansion of its 40,000-square-foot R&D facility in Harrisonburg, Va. SRI funded the $2.8 million build-out to further advance its bioscience research capabilities at SRI's Shenandoah Valley (SRI SV) Center for Advanced Drug Research.

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WIRB Copernicus Group

FDA awards 15 grants to stimulate drug, device development for rare diseases

Wednesday, October 23, 2013 02:36 PM

The FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

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MRC Technology, Boston University collaborate

Monday, October 21, 2013 01:38 PM

MRC Technology, a technology transfer organization, is collaborating with Boston University to develop an anti-IL-16 antibody for use in treatment of inflammatory diseases and Ischaemic Reperfusion Injury (IRI). The project is funded in part through a Biomedical Catalyst award of $932,000 granted to MRC Technology in 2012.

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FDA approves Actelion's Opsumit for pulmonary arterial hypertension

Monday, October 21, 2013 12:53 PM

The FDA has approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.

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New brain technology for ALS patients will launch clinical trials in Philadelphia

Monday, October 21, 2013 08:00 AM

A new technology that will enable patients suffering from ALS—commonly known as Lou Gehrig's disease—to communicate via brain monitor, will hold its first clinical trials in Philadelphia. Congressman Chaka Fattah (PA-02) was on hand for the announcement, made Tuesday at the BrainTech Israel conference in Tel Aviv.

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Moderna Therapeutics expands headquarters, laboratories

Friday, October 18, 2013 11:11 AM

Moderna Therapeutics, a developer messenger RNA therapeutics, a new treatment modality to enable the in vivo production of therapeutic proteins, has expanded their headquarters to Technology Square in Cambridge, Mass. Moderna will have up to 100 full-time employees at two locations by the end of 2013.

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FDA staff returns to work

Friday, October 18, 2013 09:02 AM

A message on the FDA website from Health and Human Service secretary Katheleen Sebelius thanked readers for their patience throughout the lapse in Federal funding. She said, “The uncertainty of the past few weeks has created many difficult situations, and the shutdown has imposed hardships on many employees as well as the public we serve.”

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Health advocates react to California Gov.’s rejection of patient access to biosimilars bill

Monday, October 14, 2013 02:19 PM

Supporters of SB 598 are reacting with disappointment over California Gov. Jerry Brown’s veto of legislation that would have made the necessary updates to state regulations in anticipation of FDA approval of biosimilar medicines. SB 598 received overwhelming bipartisan approval throughout the legislative process, passing 176-13 in five committees and three floor votes in the Assembly and Senate.

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Remembering Kathleen Drennan, pioneer in clinical trial patient recruitment

Sunday, October 13, 2013 08:44 AM

Kathleen Brady Drennan, CEO and president of Chicago-based TrialAdvance, passed away Oct. 3.

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ACRP and CenterWatch form strategic collaboration to benefit clinical research

Friday, October 11, 2013 02:22 PM

The Association of Clinical Research Professionals (ACRP) has established an official collaboration with CenterWatch that aims to provide the robust offerings developed by CenterWatch to ACRP members starting in early 2014 and establishes a relationship between the two organizations to begin a series of cooperative projects to benefit the clinical research enterprise.

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August 18

Ebola outbreak highlights need to improve biosafety, infrastructure to handle future health emergencies

More African American professional women open to participating in medical research

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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