Dec 16, 2015, 13:15 by Michael Croft

NPR.org |  Clinical trials are too white, with less than 2 percent of cancer studies including enough minority people to provide information that could be useful for health, a study finds.

Dec 15, 2015, 12:35 by Michael Croft

Clinical Informatics News | PerkinElmer announced a new analytics solution yesterday built with TIBCO Spotfire designed to help review teams, biostaticians, data managers, pharmacologists and others overcome clinical data review challenges.

Dec 14, 2015, 10:49 by Michael Croft

STAT |  A STAT analysis has found that many of the nation's top research institutions are not reporting clinical trial results as required by law.

Dec 11, 2015, 11:25 by Michael Croft

Wall Street Journal |  Novo Nordisk is teaming up with IBM Watson Health, a division of IBM, to create a "virtual doctor" for diabetes patients that could dispense treatment advice such as insulin dosage.

Dec 11, 2015, 11:22 by Michael Croft

ProPublica |  Breaches that expose the health details of just a patient or two are proliferating nationwide. Regulators focus on larger privacy violations and rarely take action on small ones, despite the harm.

Dec 9, 2015, 13:01 by Michael Croft

Clinical Leader |  As social media becomes a permanent fixture in patients' lives and pharmaceutical companies' business strategies, companies are turning to social media to recruit patients. Here's what a social media recruitment strategy should include.

Dec 8, 2015, 15:43 by Michael Croft

STAT |  A 21st Century Cures Act provision allowing more medicines to receive orphan drug status will cost consumers billions of dollars, an analysis says.

Dec 8, 2015, 08:50 by Michael Croft

PRINCETON, NJ - Dec 8, 2015 - Certara®, the global biosimulation technology-enabled drug development company, today announced the release of version 15 of its Simcyp® Population-based Simulator

Dec 7, 2015, 11:19 by Michael Croft

SANTA ROSA, CA, UNITED STATES - Dec 7, 2015 - Advera Health Analytics, Inc. will present their comparison Type 2 Diabetes Study titled “Comparisons and Cost Analysis of Post-Marketing Adverse Drug Reactions for GLP-1, DPP-4, and SGLT2 Type 2 Diabetes Medications” at the American Society of Health-Systems Pharmacists (ASHP) 2015 in New Orleans on December 6

Dec 7, 2015, 10:10 by Michael Croft

Clinical Informatics News | Last year was the first time that all of the orphan drugs approved by FDA—17 total—took advantage of the Priority Review option. But Priority Review is only one of four options available to developers of orphan compounds for expedited FDA review. In a paper published in September in The Journal of Rare Disorders, authors posit that this indicates that the options are neither fully understood by orphan drug companies nor are not being used optimally by them.

Dec 7, 2015, 09:07 by Michael Croft

RAPS |  Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of new best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.

Dec 4, 2015, 17:13 by Michael Croft

Nature News & Comment |  Geneticist Charles Danko turned to Twitter this week for help in convincing his IRB at Cornell that he should be allowed to let his study participants download their genetic information

Dec 4, 2015, 13:33 by Michael Croft

New Scientist |  Sangamo BioSciences' gene editing therapy for hemophilia B, based on zinc finger nuclease technology, can go forward in the first study of such a therapy in humans.

Dec 4, 2015, 13:27 by Michael Croft

The New Yorker |  As care providers roll out ICD-10 codes for health problems, the lengthy and highly specific list is cause for both mirth and contemplation.

Dec 3, 2015, 15:50 by Michael Croft

Clinical Informatics News | News and product launches from around the industry, including a cancer genomics project in San Antonio, and autism research in the Illumina cloud.

Dec 3, 2015, 15:30 by Michael Croft

Clinical Informatics News | With a new web portal for connecting researchers and funding sources, Cures Within Reach is doubling down on enabling successful drug repurposing research. The new 100 Projects in 100 Days initiative hopes to gather 100 proposed drug repurposing projects before mid-February, partly to prove the richness of the opportunity.

Dec 1, 2015, 09:22 by Michael Croft

PRINCETON, NJ - Dec 1, 2015 - Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Professor Piet van der Graaf, PharmD, PhD, as its vice president of quantitative systems pharmacology (QSP) and the head of its new Simcyp® QSP organization

Dec 1, 2015, 09:18 by Michael Croft

PRINCETON, NJ - Dec 1, 2015 - Certara®, the global biosimulation technology-enabled drug development company, today announced that it has acquired XenologiQ, a UK-based quantitative systems pharmacology (QSP) consultancy

Nov 30, 2015, 11:02 by Michael Croft

STAT |  The US government tried to incentivize drug makers to produce new and effective treatments for neglected diseases, but the approach hasn't gone according to plan.

Nov 30, 2015, 05:29 by Michael Croft

ONGAR, UNITED KINGDOM - Nov 30, 2015 - Scientists from the University of Edinburgh, working with Selcia, an international life sciences contract research organisation, have successfully passed the 20-month milestone targets of a 30-month Wellcome Trust SDDi £2