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Why Leveraging Technology Is The Key To Improving Healthcare
Forbes | Technology is vital if the healthcare industry wants to continue to improve the quality of its services.
Jan 4, 2017
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New FDA Drug Approvals Breaking Down the Numbers
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 4, 2017
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21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used In Healthcare
FDA Law Blog | This post focuses on only one section of the new law: Section 3060, "Clarifying Medical Software Regulation."
Jan 3, 2017
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Gates Foundation Sends $140M to Intarcia for HIV Version of Pump
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
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Amyloid Hypothesis For Alzheimers In Doubt After Lillys Drug Failure
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 29, 2016
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Liver Damage Patient Deaths Lead FDA to Halt SeaGen Leukemia Trials
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 28, 2016
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The Case For eConsent Integration
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 27, 2016
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Almac Clinical Technologies, Commonwealth Informatics, Linguamatics, And Centrexion Therapeutics: News From December 2016
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 21, 2016
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FDA Officials Call for Including Adolescents in Adult Oncology Trials
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
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SCOPE Preview: Clinical Data Strategy, Real World Data, And Precision Medicine
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 19, 2016
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Obama Signs 21st Century Cures Act Into Law
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
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Complexities of Consent
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 13, 2016
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Fred Hutch's New Bezos Family Immunotherapy Clinic Could Change the Game for Cancer Treatment
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
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The Cancer Lottery
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 12, 2016
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Baskets and Umbrellas: Trial Design for Precision Oncology
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 9, 2016
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FDA Says Real-World Evidence Could Generate Incorrect or Unreliable Conclusions
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.
Dec 8, 2016
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ERT Acquires Exco InTouch
Clinical Informatics News Brief | ERT announced this morning that it has acquired Exco InTouch. Financial terms of the transaction were not disclosed.
Dec 8, 2016
