United States

Congress approves one-year renewal diabetes research funding

Wednesday, April 2, 2014 01:51 PM

The U.S. Senate has approved legislation for a one-year extension of the Special Diabetes Program (SDP)—an initiative that accounts for roughly one-third of all federally funded type 1 diabetes (T1D) research in the U.S. The decision comes on the heels of the March 27 approval of the legislation by the U.S. House of Representatives, and will extend SDP funding for the National Institutes of Health (NIH) at the current level of $150 million, as part of the “Protecting Access to Medicare Act of 2014.”

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WIRB Copernicus Group

Institute for Genome Sciences to expand genome sequence database

Wednesday, April 2, 2014 01:49 PM

Researchers at the Institute for Genome Sciences at the University of Maryland School of Medicine have been awarded a research program contract from the FDA to sequence, assemble and annotate a population of bacterial pathogens using two high-throughput sequencing (HTS) technologies in support of the expansion of a vetted public reference database.

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CRF Health eCOA webinar series

Perficient acquires BioPharm Systems

Wednesday, April 2, 2014 01:43 PM

Perficient, an information technology consulting firm serving Global 2000 and other large enterprise customers throughout North America, has acquired BioPharm Systems, a business and information technology consulting firm focused on the life sciences industry, for approximately $17.6 million, including about $11.4 million in cash and $6.2 million of Perficient common stock.

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Potential Parkinson's Therapy secures $23M for testing from NIH

Monday, March 31, 2014 01:40 PM

Results of a study funded by the Michael J. Fox Foundation (MJFF) for Parkinson's Research have enabled researchers to secure a $23 million grant from the NIH, continuing a repurposed drug approved for hypertension to phase III testing for slowing Parkinson's progression. The trial investigating the compound isradipine will be the most advanced, current study into a disease-modifying therapy for Parkinson's disease (PD), an unmet need.

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Rho selected by HHS for clinical studies network

Monday, March 31, 2014 01:38 PM

CRO Rho’s Federal Systems Division has been selected by the U.S. Department of Health and Human Services (HHS) to be part of a network of five CROs that will design and conduct clinical studies needed to develop medical countermeasures—drugs, vaccines and diagnostic tests that help protect public health against bioterrorism, pandemic influenza and other health emergencies. 

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North Shore InnoVentures receives $1.65M from Massachusetts Life Sciences Center

Monday, March 31, 2014 01:29 PM

North Shore InnoVentures (NSIV), a New England technology incubator and business accelerator, has received a capital grant of $1.65 million from the Massachusetts Life Sciences Center (MLSC). The grant will allow NSIV to expand its current laboratory facilities over the next three years and purchase advanced analytical instrumentation. This grant is part of a larger $5 million award to the Life Sciences Consortium of the North Shore (LSCNS), consisting of Endicott College, Gordon College, North Shore InnoVentures, North Shore Community College and Salem State University, that will fund major lab/facility and equipment upgrade projects at the member institutions and organizations.

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FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

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FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

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FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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

Lessons learned from medical device trials
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Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

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