Jan 5, 2017, 09:20 by Michael Croft

Clinical Informatics News | A recent short-lived trial testing inflammatory breast cancer has helped shed new light on the implications of genomic evolution in clinical trials, especially as it pertains to trial design.

Jan 4, 2017, 15:20 by Michael Croft

Forbes |  Technology is vital if the healthcare industry wants to continue to improve the quality of its services.

Jan 4, 2017, 15:20 by Michael Croft

RAPS |  If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. But maybe that's not all bad.

Jan 3, 2017, 10:42 by Michael Croft

FDA Law Blog |  This post focuses on only one section of the new law: Section 3060, "Clarifying Medical Software Regulation."

Dec 29, 2016, 14:36 by Michael Croft

Xconomy |  Intarcia Therapeutics, a Boston biotech that's developing a tiny, implantable drug-delivery pump for type 2 diabetes, is now broadening its focus to HIV backed by as much as $140 million from the Bill & Melinda Gates Foundation.

Dec 29, 2016, 11:30 by Michael Croft

NPR.org |  The failure of an experimental drug that targets clumps of protein inside the brains of Alzheimer's patients called into question one of the leading theories about the cause of the dementia.

Dec 28, 2016, 11:42 by Michael Croft

Xconomy |  Seattle Genetics' work to develop a drug to treat a form of leukemia has hit a roadblock following the deaths of four patients in clinical trials. The FDA placed a clinical hold or partial holds on three early-stage trials evaluating the company's drug.

Dec 27, 2016, 09:30 by Michael Croft

Clinical Informatics News Contributed Commentary | The introduction of electronic informed consent (eConsent) solutions to communicate study information, while supporting the management of informed consent processes, offers huge improvements to participant on-boarding in today’s clinical trials.

Dec 22, 2016, 17:09 by Michael Croft

SAN DIEGO, CA, UNITED STATES - Dec 22, 2016 - Munich, Germany – Dec 22 2016 – Definiens, the leader in Tissue Phenomics® solutions from biomarker discovery to meaningful diagnostics, today announced a program collaboration with Takeda Pharmaceuticals to enable comprehensive tissue-based analysis in clinical trials

Dec 21, 2016, 13:30 by Michael Croft

Clinical Informatics News Briefs | News, products, and partnerships from around the clinical trial and healthcare community including news from Almac Clinical Technologies, Commonwealth Informatics, Linguamatics, and Centrexion Therapeutics.

Dec 20, 2016, 12:59 by Michael Croft

RAPS |  A team of officials at the FDA are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials. The officials made the call in a recent article in Clinical Cancer Research, where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those patients.

Dec 20, 2016, 09:07 by Michael Croft

MADISON, WI, UNITED STATES - Dec 20, 2016 - Nimblify, Inc., a clinical trials technology company, announces its free comparative analytics tool is rebranded to reflect the value it provides and meet the needs of the industryx

Dec 19, 2016, 11:30 by Michael Croft

Clinical informatics News | Clinical Informatics News will be attending the Summit for Clinical Ops Executives—SCOPE—in Miami, Fla. from January 24-26, 2017. Here’s some of what we have flagged so far.

Dec 13, 2016, 18:28 by Michael Croft

PALO ALTO, CA, UNITED STATES - Dec 13, 2016 - Bioz, Inc., developers of the world’s first search engine for life science experimentation, today highlighted six predictions for how the biotechnology industry will make strides in 2017 to advance health and drug discovery

Dec 13, 2016, 16:41 by Michael Croft

STAT |  President Obama signed the 21st Century Cures Act into law today. Surrounded by Vice President Joe Biden and the bipartisan lawmakers who helped push the bill through, Obama commented, "It's a good day to see us doing our jobs."

Dec 13, 2016, 09:45 by Michael Croft

Clinical Informatics News | As genomics continues to grow and evolve, the need to find a balance between scientific progress and patient protection is as great as ever. 

Dec 12, 2016, 09:43 by Michael Croft

GeekWire |  Immunotherapy is simple in theory, but endlessly complex in practice. The new Bezos Family Immunotherapy Clinic at the Fred Hutchinson Cancer Research Center is designed specifically to fuel the research of immunotherapy treatments.

Dec 12, 2016, 09:38 by Michael Croft

MIT Technology Review |  Finding telltale mutations in tumors and targeting those cancers with precisely selected drugs is the newest front in the war on cancer. Now researchers just have to figure out why it doesn't work for everyone.

Dec 9, 2016, 10:15 by Michael Croft

Clinical Informatics News Brief | An article published online on JAMA Oncology’s Patient Page yesterday proposes two types of clinical trial for testing precision medicine treatments of oncology.

Dec 8, 2016, 11:14 by Michael Croft

RAPS |  Fifteen top FDA officials published an article in the New England Journal of Medicine this morning attempting to clarify a definition for real-world evidence (RWE), and flagging areas of promise and concern.