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GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma

In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
- Source: gsk
- 556
- November 3, 2017
inhibitor multiple myeloma New Approvals refractory relapsed
Australian researchers to use 3D implants for bone tumour surgery

Researchers combine 3D printing and robotic surgery with advanced manufacturing. Credit: 2017 Royal Melbourne Institute of Technology.
- Source: medicaldevice-network
- 447
- November 3, 2017
3D robotic surgery
Dicerna Could Pocket $201M in NASH R&D Deal With Boehringer Ingelheim

Dicerna Pharmaceuticals and Boehringer Ingelheim today announced a research collaboration and license agreement to discover and develop novel RNAi therapeutics for the treatment of chronic liver diseases. Dicerna can get up to $201 million in upfront and success-based development and commercialization milestones for an undisclosed target.
- Source: biospace
- 541
- November 3, 2017
chronic liver diseases Market Views RNAi
Bristol-Myers, J&J sink cash into a new $95M European biotech fund

A venture capital firm in the Netherlands — backed by some big names in Big Pharma — has raised $95 million in a new fund to fuel European biotech startups.
- Source: Endpts
- 617
- November 3, 2017
diagnostics funding Market Views medical device therapeutics
Cancer-detecting start-up Grail is seeking more funding, mere months after raising $900 million

Grail, the cancer detection start-up backed by tech giants Alphabet and Amazon, is already seeking new funding, mere months after it closed a $900 million round in March. The company had previously raised $100 million in 2016.
- Source: Cnbc
- 461
- November 2, 2017
cancer detection funding Market Views
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
- Source: news.abbvie
- 736
- November 2, 2017
antagonist biopharmaceutical GnRH New Approvals
Scientists discover 27 genes that could halt cancer

From an analysis of more than 2,000 tumors spanning 12 types of human cancer, scientists have identified 27 new genes that could stop the disease in its tracks.
- Source: medicalnewstoday
- 676
- November 2, 2017
cancer Researches suppressor genes tumor
Wearable Devices–A New Look For The Modern Clinical Trial

Clinical development has historically been a laborious and expensive process that stretches across all therapeutic areas. It is driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs. Depending on whose data you believe, getting a new drug to market can now cost upwards of $1 billion and take more than 10 years or research and development effort. Additionally, a complex and dynamic regulatory framework has made sponsors reluctant to introduce new technologies to facilitate the development process.
- Source: clinicalleader
- 988
- November 2, 2017
Artificial Intelligence Clinical machine learning Researches wearables
Flu Vax May Improve Outcomes in Other Illnesses

Even when the flu vaccine doesn't prevent disease, it can ease some of the consequences, researchers said here.
- Source: medpagetoday
- 835
- November 2, 2017
disease flu Researches vaccine
Joining ICH–Opportunity or Challenge?

Ddu has gradually made its way through Europe by attending the CPhI Worldwide 2017 in Frankfurt and Medica 2017 in Düsseldorf, Germany. During conversations with manufacturers, ICH was frequently mentioned. Since China was admitted as one of the regulatory members of ICH in June of last year, it was now placed at the forefront of the discussions.
- Source: drugdu
- 729
- November 2, 2017
Ddu College EC FDA ICH MHLW PMDA

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