Theorem Clinical Research

United States

Inhibikase Therapeutics receives Orphan Drug Designation for PML

Thursday, May 22, 2014 11:08 AM

Inhibikase Therapeutics, a developer of products to treat infectious diseases with little or no resistance, has received Orphan Drug Designation for imatinib to treat progressive multifocal leukoencephalopathy (PML) from the FDA.

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Report: Value of U.S. health services M&A deals up 152%

Wednesday, May 21, 2014 01:29 PM

U.S. health services M&A total deal value rose 152% to $12.3 billion during the first quarter of 2014 compared to the same period in 2013, according to an analysis of M&A trends and outlook for the health services sector issued by PricewaterhouseCoopers U.S.

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PDS launches first publicly available, FDA-validated dataset for SEND

Wednesday, May 21, 2014 01:28 PM

PDS, a global provider of intuitive data management software and solutions for life sciences research, has made an FDA-validated, preclinical research SEND dataset available to the public free of charge and qualification.

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Kymab receives $40M investment from Wellcome Trust, Gates Foundation

Monday, May 19, 2014 01:25 PM

The Bill & Melinda Gates Foundation and the Wellcome Trust each invested $20 million in Kymab, a monoclonal antibody biopharmaceutical company, to enable Kymab to maximize its Kymouse platform and advance its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies in areas of significant unmet medical need, including cancer and inflammation.

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SAFE-BioPharma added to worldwide Adobe Approved Trust List

Friday, May 16, 2014 11:32 AM

Adobe has added SAFE-BioPharma to its Adobe Approved Trust List (AATL). Effective immediately, anyone with a SAFE-BioPharma identity credential will be able to sign a PDF document in Adobe Acrobat, or Reader that will be automatically trusted globally by any other user of Adobe Acrobat, or Reader.

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Janssen Labs expands to San Francisco, adds three to @LabCentral

Thursday, May 15, 2014 01:26 PM

Janssen Labs, part of Janssen R&D, plans to open Janssen Labs @South San Francisco, a new 30,000-square-foot, standalone operation based in South San Francisco, Calif. The new location will accommodate up to 50 independent, emerging companies to be co-located with staff from Johnson & Johnson Innovation. Like the flagship Janssen Labs in San Diego, Janssen Labs @South San Francisco will include a combination of shared and private lab and office spaces and feature value-added solutions including operational support, education and business services. Janssen Labs @South San Francisco is scheduled to open at the end of the year.

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Pernix to acquire Treximet migraine tablets from GlaxoSmithKline

Thursday, May 15, 2014 11:23 AM

Pernix Therapeutics, a specialty pharmaceutical company, has signed an agreement with GlaxoSmithKline to acquire the U.S. rights to Treximet (sumatriptan / naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults.

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Kinex Pharmaceuticals appoints two to New Jersey clinical office

Wednesday, May 14, 2014 03:22 PM

Kinex Pharmaceuticals has announced the addition of two key executives to its clinical leadership team reporting to chief medical officer, Dr. Rudolf Kwan. Douglas Kramer, M.D., joins Kinex as vice president of Clinical and Regulatory Affairs and Jane Devane has joined Kinex as director of Clinical Operations.

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Abeona Therapeutics receives FDA Orphan Drug Designations for Sanfilippo

Wednesday, May 14, 2014 02:54 PM

Abeona Therapeutics, a start-up company created around intellectual property licensed from Nationwide Children's Hospital to develop treatments for Sanfilippo Syndrome Types A and B, has been granted Orphan Drug Designations for its lead investigational therapies by the FDA Office of Orphan Products Development. Following the successful close of seed financing in late 2013, Abeona is raising funds to advance its gene therapy-based clinical programs for both Sanfilippo Syndrome type A and B. Phase I/II clinical trials for both diseases are anticipated to begin in 2014.

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UCLA receives $4 million from Eli and Edythe Broad Foundation

Wednesday, May 14, 2014 01:05 PM

Two new gifts from the Eli and Edythe Broad Foundation to UCLA totaling $4 million will fund research in stem cell science and digestive diseases and support the recruitment of key faculty at two research centers.

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Reality of costs and impact rain on Sunshine Act
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