United States

CAP-ASCCP make recommendations to stadardize histopathologic terminology, guide optimal biomarker use

Monday, September 10, 2012 10:17 AM

A working group from the Lower Anogenital Squamous Terminology (LAST) Standardization Project, an interdisciplinary project led by the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP), has published consensus recommendations to standardize the histopathologic terminology for squamous epithelial lesions of the lower anogenital tract associated with human papillomavirus and to guide optimal biomarker use, according to Ventana Medical Systems, a member of the Roche Group.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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Orexo submits NDA for Zubsolv for opiod dependence

Friday, September 7, 2012 01:41 PM

Orexo, an emerging specialty pharmaceutical company, has submited a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

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Charles River opens new biomedical diagnostic facility

Friday, September 7, 2012 12:30 PM

Charles River Laboratories, a global preclinical CRO, has opened its new biomedical diagnostic testing facility in Wilmington, Mass.

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Galenea receives $3M to develop translational EEG biomarkers for schizophrenia

Friday, September 7, 2012 12:22 PM

Researchers at Galenea, based in Cambridge, Mass., and collaborator Dr. Kevin Spencer of the VA Boston Healthcare System and Harvard Medical School, have been awarded a five-year, $3 million grant from the National Institute of Mental Health (NIMH).

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Spectrum completes acquisition of Allos

Friday, September 7, 2012 10:59 AM

Spectrum Pharmaceuticals (SPPI), an Irvine, Calif.-based biotech focused on hematology and oncology, has completed its acquisition of Allos Therapeutics, a Westminster, Colo.-based developer of small molecule drugs.

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Pulmatrix appoints Robert Clarke as CEO

Thursday, September 6, 2012 08:28 AM

Pulmatrix, a Lexington, Mass.-based clinical stage biotechnology company, has promoted Robert Clarke, Ph.D., to the position of CEO and to the board of directors.

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FDA approves Pfizer’s new orphan drug for chronic myelogenous leukemia

Thursday, September 6, 2012 08:25 AM

The FDA has approved Pfizer’s Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.

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Cellerant awarded $36.4M to develop CLT-008 for acute radiation syndrome

Thursday, September 6, 2012 07:48 AM

Cellerant Therapeutics, a biotech developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, has been awarded $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the office of the assistant secretary for preparedness and response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of acute radiation syndrome (ARS).

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Janssen R&D gains FDA priority review for TB drug

Wednesday, September 5, 2012 11:32 AM

The FDA has granted Janssen Research & Development priority review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

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