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AMAG Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application (sNDA) for Feraheme® (ferumoxytol injection)

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
- Source: Amagpharma
- 695
- February 8, 2018
chronic kidney disease FDA Feraheme New Approvals
De Rothschild raises €345M Europe-skewed life science fund

Edmond De Rothschild Investment Partners has raised €345 million ($430 million) for its latest fund. The haul makes BioDiscovery 5 the largest fund dedicated to biotechs and medical devices in Europe and tees up Edmond De Rothschild to invest in 15 to 17 companies.
- Source: FierceBiotech
- 578
- February 8, 2018
biotech Company Insight medical device
Has Health IT Adoption Improved Patient Outcomes?

It had been a few years since the last systematic literature review of the effect health information technology (HIT) has on patient outcomes, and much has changed since. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 encouraged widespread electronic health record (EHR) adoption, vaulting them to near-ubiquity.
- Source: HCANews
- 1,151
- February 8, 2018
health IT Market Views Researches
Amazon Wants to Disrupt Health Care in America. In China, Tech Giants Already Have

Amazon and two other American titans are trying to shake up health care by experimenting with their own employees’ coverage. By Chinese standards, they’re behind the curve.
- Source: New York Times
- 571
- February 8, 2018
digital health health IT Market Views
Pfizer vs J&J– Researchers are duking it out for the championship title in nonmetastatic prostate cancer

Pfizer $PFE and J&J $JNJ have come down to the wire with pivotal data on nonmetastatic prostate cancer. And there are billions of dollars in revenue on the line here.
- Source: Endpts
- 457
- February 7, 2018
Market Views prostate cancer
Heart Study app could be Apple’s first FDA-cleared product

The Apple Heart Study — which began enrollment at the end of November — has now begun data collection, with participants receiving prompts over the weekend to sign informed consent documents and initiate data collection. That document also reveals some new details about how Apple plans to use data collected during the study.
- Source: MobiHealthNews
- 1,037
- February 7, 2018
App Apple Company Insight FDA mHealth
Medial EarlySign’s AI scans medical records for diabetes warning signs

A machine learning technology developed to spot dangerous medical conditions before they worsen has shown its value in a trial.
- Source: PharmaPhorum
- 584
- February 7, 2018
AI diabetes NHS Researches
Philippines’ launches legal action after Sanofi refuses to refund over dengue vaccine damages

Sanofi has refused both requests from the Government of the Philippines to refund used doses of its Dengvaxia vaccine as well as the costs of medical treatment of first-time dengue patients who were harmed after its use in the nation’s vaccination programme of 837,000 children.
- Source: Pharmafile
- 546
- February 7, 2018
Company Insight dengue
Scientists see positive results from 1st ever gene editing therapy

A second patient has been treated in a historic gene editing study in California, and no major side effects or safety issues have emerged from the first man’s treatment nearly three months ago, doctors revealed Tuesday.
- Source: NYPost
- 498
- February 7, 2018
gene editing Gene therapy New Approvals
BMS’ Opdivo and Yervoy combo better than chemo in halting lung cancer progression

Bristol-Myers Squibb has revealed promising data from its ongoing Phase 3 study investigating the efficacy of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients whose cancers have a high tumour mutation burden (TMB), regardless of PD-L1 expression.
- Source: pharmafile
- 556
- February 7, 2018
BMS Chemotherapy NSCLC Opdivo TMB Yervoy

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