• FDA Officials: There Was “No Scientific Basis” For Duchenne Drug OK As Sarepta Complained Of “Dire Financial” Condition

    Endpoints News |  Two senior FDA officials mounted a vehement assault on Janet Woodcock's decision to push through an approval of Sarepta's Duchenne muscular dystrophy drug Exondys 51. New documents posted by the FDA, including a round of memos on the issue in September, warned FDA Commissioner Robert Califf that he was allowing an approval even though Woodcock had not considered all the analysis they had done to underscore the company's weak case, adding that there was no scientific basis to conclude that the drug was reasonably likely to benefit patients.

    Nov 4, 2016

  • What clinical trial results? Now you can see who isnt sharing their findings

    STAT |  A tracker was launched by a group of researchers and medical journals that has been pushing the pharma industry to do a better job of disclosing trial data.

    Nov 3, 2016

  • Why The Approach To Drug Pricing Has To Change Now

    Forbes |  As an industry, we must shift to a model that focuses on value and outcomes delivered, both to patients and to health systems.

    Nov 2, 2016

  • Litmus Health Seeks Alternative In Data Gathering For Clinical Trials

    Clinical Informatics News | Litmus Health recently launched into public beta at the University of Chicago. The data science platform has ambitions to make “the entire world will be one big clinical trial.”

    Nov 2, 2016

  • Cures Bill in Jeopardy Amid Drug Pricing Push

    The Hill |  A coalition of liberal groups has come out against passage of the measure this year, further putting its future in doubt.

    Nov 1, 2016

  • In Defense of Data Sharing But Done In The Right Way

    STAT |  If data are collected using standards that are compatible with each other, they will be more easily shared and provide the greatest return.

    Oct 31, 2016

  • Large Molecule Clinical Trials Taking Longer, Costing More

    Outsourcing-Pharma |  Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.

    Oct 31, 2016

  • 23andMe Reaches Enrollment Goal for Lupus Research

    23andMe |  23andMe and Pfizer are collaborating on a lupus trial. The two have enrolled 5,000 people with autoimmune disease, and hope to use genetic and survey data to learn more about the genetics of lupus.

    Oct 28, 2016

  • Comparing Drug And Medical Device Clinical Trials

    MassDevice |  Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

    Oct 28, 2016

  • Veeva, Quanticate, The Forerunner Group, and more: News from October 2016

    Clinical Informatics News Briefs | New partnerships and products from BBK Worldwide, Emulate, Veeva, and more.

    Oct 28, 2016

  • Better Together: Unified Clinical Systems & Processes

    Clinical Informatics News | Typically, sharing information in the life sciences industry has proven more challenging primarily because of siloes in place between not only companies, but also functional areas within an organization. A unified clinical technology landscape can have a positive impact that ripples throughout the entire organization. 

    Oct 27, 2016

  • EpiPen Prescriptions Continue To Climb But Market Share Dropped

    STAT |  New data indicates prescriptions for the allergy emergency device are outpacing last year's figures. Overall, the number of prescriptions for EpiPen is up 14% through September, compared with the same period in 2015. In fact, there were 40% more prescriptions written in the first nine months of this year compared with 2013, even as the price for EpiPen was rising.

    Oct 25, 2016

  • Dell Technologies Announces Availability of EMC Documentum for Life Sciences 4.2

    Clinical Informatics News Brief | Dell Technologies Enterprise Content Division (ECD) announced the general availability of EMC Documentum for Life Sciences 4.2.
The EMC Documentum for Life Sciences solution suite is designed to break down information silos to transform how organizations access, manage, and share regulated content.

    Oct 24, 2016

  • UK Aims To Cut Four Years From Drug Development Process

    Pharmaphorum |  The UK government has published its long-awaited Accelerated Access Review, a report that aims to cut up to four years from the process that gets a drug from the lab to use on England's National Health Service.

    Oct 24, 2016

  • FDA Official Warns Other Drug Makers Not to Copy Sarepta

    STAT |  An FDA official said this week that Sarepta's approach in winning approval for its DMD drug should not be copied by other drug firms.

    Oct 21, 2016