Theorem Clinical Research

FDA

Novartis to open Center for Advanced Cellular Therapeutics at University of Pennsylvania

Monday, September 15, 2014 12:29 PM

The University of Pennsylvania’s alliance with Novartis has unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

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Cellerant awarded $47.5M for development of CLT-008 for acute radiation syndrome

Friday, September 12, 2014 01:16 PM

Cellerant Therapeutics, a California biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, has been awarded $47.5 million under a second 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.

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PhRMA: 44 medicines and vaccines in development for HIV/AIDS

Friday, September 12, 2014 01:13 PM

America’s biopharmaceutical research companies currently are developing 44 medicines and vaccines for HIV/AIDS treatment and prevention, according to the latest Medicines in Development report by the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA). A second report, The Value of Innovation in HIV/AIDS Therapy, a PhRMA-sponsored white paper by Boston Healthcare Associates (BHA), highlights the progress in HIV/AIDS treatment and its impact on patients afflicted with the disease. 

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FDA approves weight-management drug Contrave

Friday, September 12, 2014 12:49 PM

The FDA has approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

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Louis J. DeGennaro named president and CEO of the Leukemia & Lymphoma Society

Thursday, September 11, 2014 03:33 PM

The Leukemia & Lymphoma Society (LLS) has appointed Louis J. DeGennaro, Ph.D., president and CEO, effective immediately.

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VentiRx Pharmaceuticals receives Fast Track designation for Motolimod (VTX-2337)

Friday, September 5, 2014 10:59 AM

The FDA has granted Fast Track designation to VentiRx Pharmaceuticals’ motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled, phase II trials.

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Frost & Sullivan honors Clinical Ink for eSource platform that streamlines clinical development

Friday, September 5, 2014 10:56 AM

Based on its recent analysis of the eClinical solutions market, Frost & Sullivan recognizes Clinical Ink with the 2014 North American eClinical Solutions Award for Entrepreneurial Company of the Year. The award recognizes Clinical Ink's innovative SureSource platform—the first purpose-built eSource solution that captures data electronically at the point of care.

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Debiopharm Group's antibiotic Debio 1450 receives QIDP designation from the FDA

Friday, September 5, 2014 09:40 AM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, has announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

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HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

Thursday, September 4, 2014 12:22 PM

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

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NIH releases new priority list of drugs it wants tested in children

Thursday, August 28, 2014 01:09 PM

The NIH has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

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CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

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

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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