DIA Biosimilars 2013

National Cancer Institute

Chrysalis BioTherapeutics receives $1.5m from the National Cancer Institute

Wednesday, September 25, 2013 12:33 PM

Chrysalis BioTherapeutics has announced receipt of a $1.5 million contract from the National Cancer Institute (NCI) to continue its development of Chrysalin to mitigate radiotherapy-induced damage to normal brain tissue.

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Cenduit: Now with Patient Reminders

Idera Pharmaceuticals, NCI collaborate

Friday, August 30, 2013 02:25 PM

Idera Pharmaceuticals entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Cancer Institute (NCI) to evaluate the company’s Toll-like receptor (TLR) antagonists as a potential approach to the treatment of certain genetically defined B-cell lymphomas.

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CRF Health – eCOA Forum

Northwestern Medicine enrolls first participant in brain tumor trial

Wednesday, August 28, 2013 02:47 PM

Northwestern Medicine recently joined a clinical trial to investigate if a vaccine made from a patient's own brain tumor is effective in slowing tumor progression and extending survival. The randomized, phase II trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).

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Arisaph awarded phase I STTR grant

Tuesday, August 6, 2013 11:06 AM

Arisaph Pharmaceuticals, a privately held drug discovery and development biopharmaceutical company focused on developing novel therapies for cardiometabolic diseases and cancer, has been awarded a phase I Small Business Technology Transfer (STTR) award from the National Cancer Institute of the NIH. The award supports the R&D of Arisaph's small molecule immune modulators to stimulate tumor immunity following treatment with BRAF inhibitors in cancer.  

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TSRI awarded $1.4M for chronic leukemia research

Thursday, June 27, 2013 01:09 PM

Scientists from The Scripps Research Institute (TSRI) have been awarded more than $1.4 million from the National Cancer Institute of NIH to create a potential new drug to attack the malignant cells that cause chronic lymphocytic leukemia (CLL).

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Former FDA official Tim Cote joins Emmaus Medical as regulatory advisor

Friday, May 10, 2013 08:00 AM

Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has appointed Timothy Cote, M.D., MPH, former director of the Office of Orphan Product Development of the FDA, as its regulatory advisor. Cote will advise Emmaus on the regulatory pathway for the company's sickle cell disease treatment.

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C-Path names Martha Brumfield as CEO

Tuesday, February 26, 2013 11:58 AM

The board of directors of the Critical Path Institute (C-Path), an independent, nonprofit organization, have named Martha Brumfield, Ph.D., as interim president and CEO. Brumfield, C-Path’s former director of international and regulatory programs, will take over immediately for Carolyn Compton, M.D., Ph.D. who will be assuming a new position at Arizona State University (ASU).

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Lentigen receives Orphan Drug status for gene therapy for glioblastoma multiforme

Thursday, February 14, 2013 08:00 AM

Lentigen, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery products, announced that that the FDA has granted orphan drug status to LG631-CD34, P140K methylguanine methyltransferase (MGMT) transduced human CD34 cells, for bone marrow protection in the treatment of glioblastoma multiforme.

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FDA approves Gleevec for children with acute lymphoblastic leukemia

Monday, January 28, 2013 11:22 AM

The FDA has approved a new use for Novartis’ Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

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CDISC names additions to board of directors

Friday, January 25, 2013 12:27 PM

CDISC, a global, open, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata, has named five highly qualified individuals that will add invaluable expertise to the CDISC board of directors (BoD) for a three-year term beginning this month (2013–2016): Dr. Carolyn Compton, Michael Glickman, Dr. Douglas Peddicord, Stephen Pyke and John Speakman.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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