DIA Biosimilars 2013

United States

PPD names VP for global product development

Monday, September 23, 2013 01:30 PM

CRO PPD has appointed Gregory Dennis, M.D., vice president of global product development. Dennis will be therapeutic area head, providing medical and scientific expertise for rheumatology, immunology and inflammatory diseases.

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Cenduit: Now with Patient Reminders

Perrigo appoints Keith Webber head of regulatory review

Monday, September 23, 2013 09:46 AM

Perrigo has appointed Keith Webber head of regulatory review, effective Oct. 21. This new role will have responsibility for advancing the approval of all of Perrigo's Consumer Healthcare (CHC) and Prescription Pharmaceutical (Rx) regulatory applications pending with the FDA, providing guidance on scientific and regulatory strategy for new CHC and Rx pipeline products under development and continuously advancing the quality of new regulatory applications. 

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CRF Health – eCOA Forum

GSK inks agreement with BARDA to supply anthrax treatment

Friday, September 20, 2013 11:32 AM

GlaxoSmithKline has signed a new four-year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), for the provision of its inhalation anthrax treatment, raxibacumab. The U.S. government is purchasing the medicine as a counter measure against a potential bioterrorist attack.

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NIH awards $33m grant to Banner Alzheimer's Institute, study planned

Friday, September 20, 2013 11:14 AM

Banner Alzheimer's Institute (BAI) has announced a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer's disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

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NYSCF an associate member of NYGC

Friday, September 20, 2013 11:07 AM

The New York Stem Cell Foundation (NYSCF) has become an associate member of The New York Genome Center (NYGC), joining NYGC's growing consortium of 16 research and clinical institutions, all working together in new ways to utilize genomic data for better detection, treatment, and prevention of disease.

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BioTime, Jade Therapeutics ink deal

Friday, September 20, 2013 10:52 AM

BioTime, a biotechnology company that develops and markets products in regenerative medicine, has signed an exclusive sublicense agreement with Jade Therapeutics, a Salt Lake City, Utah-based developer of ophthalmic sustained-release drug delivery platforms. This new agreement supersedes the previously announced sublicense and supply agreements and expands the licensed field of use to include certain additional uses, such as BioTime’s HyStem hydrogel technology for the delivery of all potential therapeutic molecules to the human eye. Excluded from the licensed field of use is the HyStem technology for the delivery of cells with or without any molecules necessary for the therapeutic benefit of those cells, for use in making punctal plugs, for diagnostic and research reagents and for non-human applications.

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Texas Heart Institute, TAMU receive $3m for biotechnology center

Wednesday, September 18, 2013 11:04 AM

The Texas Heart Institute (THI) and Texas A&M University (TAMU) College of Veterinary Medicine and Biomedical Sciences have received a $3 million grant through the Texas Emerging Technology Fund (TETF) to create the Center for Cell and Organ Biotechnology

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Report: More than 270 vaccines in biopharmaceutical pipelines

Wednesday, September 18, 2013 11:01 AM

America’s biopharmaceutical companies are currently developing 271 vaccines to prevent and treat conditions including infectious diseases, cancer and neurological disorders, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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MIT awarded $25m for human computer development

Wednesday, September 18, 2013 10:42 AM

The National Science Foundation (NSF) has awarded $25 million to establish a Center for Brains, Minds and Machines at the Massachusetts Institute of Technology (MIT). The center is one of three new research centers funded this year through NSF's Science and Technology Centers: Integrative Partnerships program.

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Boehringer Ingelheim collaborates with Presidio Pharmaceuticals

Monday, September 16, 2013 03:12 PM

Boehringer Ingelheim has completed patient enrollment for a phase IIa clinical trial (NCT01859962) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. This trial is conducted in collaboration with Presidio Pharmaceuticals and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

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CWWeekly

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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