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Drug Safety Communication – Boxed Warning Added To Highlight Correct Dosing

FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.
- Source: fda
- 568
- February 6, 2018
Boxed Warning FDA liver disease Ocaliva PBC
Insightec closes $150m Series E

HAIFA, Israel and MIAMI, Florida – INSIGHTEC®, a commercial-stage medical technology company revolutionizing surgery with incisionless MRI-guided focused ultrasound (MRgFUS) announced today the closing of a $150 million Series E private equity investment round. Koch Disruptive Technologies (KDT), a subsidiary of Koch Industries, focused on finding and funding innovative and emerging companies, led the round with a $100 million investment.
- Source: drugdu
- 517
- February 6, 2018
Market Views MRgFUS non-invasive treatments
Why healthcare cybersecurity spending will exceed $65B over the next 5 years

Hospitals and healthcare providers remain under cyber attack, causing organizations to spend more to protect their systems and patient data.
- Source: CSO Online
- 558
- February 6, 2018
cybersecurity digital health Market Views
Hospitals turn to mobile devices to cut costs, study shows

More than nine in 10 nurse managers see voice recognition and telehealth technologies intensifying over the next five years, while secure text messaging, voice communication and photographing wounds and skin conditions will be nearly universal. Major growth is expected in areas like remote patient monitoring.
- Source: Healthcare Dive
- 736
- February 5, 2018
digital health Market Views medical device
Preview — Global Pharmaceutical & Medical Device Exhibitions in February, 2018

Have you made your schedule for 2018? Take some time to consider your options and see what Ddu has planned this February!
- Source: Ddu
- 1,188
- February 2, 2018
Exhibitions & Activities medical device pharmaceutical
Digital health had record funding year, but noticeable drop in exits

In many ways, 2017 was a banner year for digital health funding, according to Rock Health's annual report, which puts funding for the year at a record $5.8 billion.
- Source: Mobi Health News
- 476
- February 2, 2018
digital health investment Market Views
NICE becomes latest champion for digital health

NICE has become the latest organisation to champion digital health, recommending that the NHS should trial an online and mobile programme to treat depression.
- Source: Pharma Phorum
- 745
- February 1, 2018
Company Insight digital health EHR NICE
Adverum Biotechnologies and Editas Medicine Extend Research Collaboration

Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, announced today an extension of its collaboration agreement with Editas Medicine, Inc. (Nasdaq:EDIT). The companies established this collaboration to explore the delivery of genome editing medicines to treat up to five inherited retinal diseases.
- Source: investors.adverum
- 467
- January 31, 2018
genome editing Market Views retinal diseases
Berkshire Hathaway, Amazon, chase partner to create healthcare company

It’s no secret Jeff Bezos has been looking to crack healthcare. But no one expected him to pull in Warren Buffett and Jamie Dimon, too.
- Source: Digital Insurance
- 433
- January 31, 2018
Company Insight healthcare
TriNetX buffs Sanofi’s digital trials and other digital health deals

Sanofi has found yet another partner to help digitize its clinical trial processes. In a statement, TriNetX announced that it will be assisting the pharmaceutical company by using patient EHRs to optimize recruitment, streamline trial investigators’ workflows, and otherwise impact the design of investigational drug trials. Sanofi has made similar arrangements to bolster its clinical trials with Science 37 and Evidation in March and July of last year, respectively.
- Source: MobiHealthNews
- 702
- January 30, 2018
Clinical Trials Company Insight EHR Sanofi

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