Theorem Clinical Research

Centers for Disease Control and Prevention

Johnson & Johnson to speed Ebola vaccine development, expand production

Thursday, October 23, 2014 01:03 PM

Johnson & Johnson has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), as well as other key stakeholders, governments and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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Tekmira joins consortium conducting Ebola virus trials in West Africa

Wednesday, September 24, 2014 01:22 PM

Tekmira Pharmaceuticals, a British Columbia-based developer of RNA interference (RNAi) therapeutics, is collaborating with an international consortium to provide an RNAi-based investigational therapeutic for expedited clinical studies in West Africa.

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Gates Foundation commits $50M to support emergency response to Ebola

Friday, September 12, 2014 01:13 PM

The Bill & Melinda Gates Foundation plans to commit $50 million to support the scale up of emergency efforts to contain the Ebola outbreak in West Africa and interrupt transmission of the virus.

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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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Johnson & Johnson to accelerate Ebola vaccine program in collaboration with NIH

Thursday, September 4, 2014 12:29 PM

Johnson & Johnson has committed to accelerate its Ebola vaccine program in collaboration with the NIH. J&J will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate to deliver immediate relief aid to address the current Ebola outbreak.

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23andMe, Pfizer to research genetics of inflammatory bowel disease

Wednesday, August 13, 2014 01:15 PM

23andMe, a California-based personal genetics company, and Pfizer have inked a research agreement in which the companies aim to enroll 10,000 people with inflammatory bowel disease (IBD) in a research initiative designed to explore the genetic factors associated with the onset, progression, severity and response to treatments for IBD.

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CDC awards Leidos $44 million contract

Thursday, July 31, 2014 12:37 PM

Leidos, a national security, health and engineering solutions company, was awarded a prime task order by the Centers for Disease Control and Prevention (CDC) to provide development, support and maintenance of the National Healthcare Safety Network (NHSN).

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Human Longevity hires for clinical, regulatory/scientific and informatics

Thursday, May 22, 2014 10:43 AM

Human Longevity (HLI), a genomics and cell therapy-based diagnostic and therapeutic company, has announced three senior appointments to help build the company's business and technology platforms.

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Rutgers receives $26M antibiotics grant from NIH

Wednesday, April 30, 2014 11:26 AM

The National Institute of Allergy and Infectious Diseases (NIAID) of the NIH has selected infectious disease expert David Perlin, executive director of the Public Health Research Institute at Rutgers New Jersey Medical School, to lead a major research effort aimed at developing new forms of antibiotics to regain the upper hand over deadly bacteria that have become resistant to current treatments.  

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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