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In a medical first, drugs have reversed an inherited disorder in the womb

Doctors in Germany successfully treated twins in utero using a biotech drug, pointing to a new way to eliminate disease.
- Source: TechnologyReview
- 424
- April 28, 2018
digital health medtech Researches
FDA plans to launch ‘Pre Cert 1.0’ by the end of 2018, issues working model for digital health regulation

The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year.
- Source: FiercePharma
- 629
- April 28, 2018
digital health FDA Policies
Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
- Source: nvestors.foundationmedicine
- 596
- April 27, 2018
FDA liquid biopsy assay microsatellite instability
Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
- Source: us.gsk
- 652
- April 27, 2018
Company Insights COPD FDA GSK
AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
- Source: prnewswire
- 659
- April 27, 2018
AbbVie FDA New Approvals plaque psoriasis
Zymeworks and Celgene Expand Bispecific Antibody Collaboration

Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that Celgene Corporation has exercised its right to expand its collaboration agreement for the research, development, and commercialization of bispecific antibody therapeutics using Zymeworks’ Azymetric™ platform.
- Source: ir.zymeworks
- 660
- April 27, 2018
bispecific antibody therapeutics Celgene Market Views
Nvidia looks to AI for the future of medical imaging technologies

The name Nvidia usually creates a synapse to the video game industry — or more recently the self-driving car business. But now the computer hardware company is looking to get a foothold in the healthcare industry.
- Source: MobiHealthNews
- 532
- April 27, 2018
AI Company Insights digital health
mHealth app for clinical decision support improves diagnosis time, test ordering

Mobile health (mHealth) applications for clinical decision support could improve physicians’ test ordering and diagnosis decisions, according to a study published April 20 in the Journal of Informatics in Health and Biomedicine.
- Source: Clinical Innovation
- 635
- April 27, 2018
Clinical mHealth Researches
As FDA’s Pre-Cert plan takes shape, worries emerge about overreach

Yesterday morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
- Source: MobiHealthNews
- 628
- April 27, 2018
FDA medical device products Policies
Third Rock Ventures Launches Cedilla Therapeutics with $56 Million Investment to Target Protein Stability Using Small Molecule Therapeutics

Company is targeting upstream aspects of native protein degradation pathways to develop new therapies for cancer
- Source: drugdu
- 712
- April 26, 2018
Market Views Series small molecule

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