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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

GvHD is a potentially life-threatening medical complication, which can affect patients receiving such transplants to treat certain genetic diseases and haematologic cancers. Orencia is an immunomodulator that disturbs

The post Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD appeared first on Pharmaceutical Business review.

AWS announces strategic collaboration with Novartis to accelerate digital transformation of its business operations

This enterprise-wide data and analytics platform is expected to form the foundation for custom solutions powered by AWS AI and ML services to help drive agility, innovation, and

The post AWS announces strategic collaboration with Novartis to accelerate digital transformation of its business operations appeared first on Pharmaceutical Business review.

Gatehouse Bio collaborates with AstraZeneca to accelerate new drug discovery

Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways correlated to and potentially driving disease. “Our annotation library of over 1.4M small RNA

The post Gatehouse Bio collaborates with AstraZeneca to accelerate new drug discovery appeared first on Pharmaceutical Business review.

Irish growth opportunities highlighted at Medtech Rising
Published: 5 Dec 2019 | 14:34 UTC

The Irish Medtech Association, the Ibec group that represents the medtech sector, Enterprise Ireland and IDA Ireland has highlighted global growth opportunities for the Irish medtech industry at Medtech Rising: The Irish Medtech CEO Conference.

Medical device industry sees 12.7% rise in deal activity - GlobalData
Published: 5 Dec 2019 | 10:07 UTC

Europe’s medical devices industry saw a rise of 12.7% in overall deal activity during Q3 2019, when compared to the four-quarter average, according to GlobalData’s deals database.

Collaboration established to deliver federated learning in life sciences
Published: 5 Dec 2019 | 9:34 UTC

Owkin, which is developing federated learning and AI technologies to advance medical research, has announced a collaboration with technology firm NVIDIA and King’s College London (KCL) to deliver federated learning in healthcare and life sciences.

Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder
Published: 5 Dec 2019 | 1:12 UTC

TARRYTOWN, N.Y., Dec. 5, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced topline data from the pozelimab (REGN3918) Phase 2 clinical program in paroxysmal nocturnal hemoglobinuria (PNH),...

US Pharmaceutical Industry Continues to Shine According to CPhI 2019 Annual Report
Published: 5 Dec 2019 | 0:00 UTC

Survey Results Highlight Continuing Strength of US Sector Along with Advances by Emerging Market Competitors

Announcement of collaborative research agreement with National Cancer Center on analysis of gut bacteria related to cancer
Published: 5 Dec 2019 | 0:00 UTC

bitBiome, Inc. and National Cancer Center of Japan have signed a collaborative research agreement on the analysis of gut bacteria related to cancer on November 22nd..

Global Esophageal Cancer Drugs Market 2019-2023 | Evolving Opportunities with Eli Lilly and Company and Sanofi | Technavio
Published: 5 Dec 2019 | 0:00 UTC

Technavio has announced its latest market research report titled global esophageal cancer drugs market 2019-2023

Cymerus™ MSCs Effective in Preclinical Model of Sepsis
Published: 5 Dec 2019 | 0:00 UTC

Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has received positive efficacy data from preclinical studies of its Cymerus™ mesenchymal stem cells (MSCs) in a model of sepsis.

U.S. Tops List of Trial Startups With China Making Progress in Phase 1
Published: 4 Dec 2019 | 22:56 UTC

China is rapidly making headway in phase 1 clinical trials, although the U.S. remains the world leader in phase 1 through 3 trials overall.

Nordic Nanovector: New preclinical Data Offer Insights Into Enhancing Betalutin®-Based Therapies in NHL
Published: 4 Dec 2019 | 0:00 UTC

Nordic Nanovector ASA announces that new data from preclinical studies investigating the effect of Betalutin® on non-Hodgkin's lymphoma cell lines will be presented in a poster at the 61st American Society of Hematology Annual Meeting & Exposition.

FDA collaborates with Elsevier on drug-induced liver injury (DILI) tool
Published: 3 Dec 2019 | 8:30 UTC

A leading cause of attrition of compounds in drug development, drug-induced liver injury (DILI) is also one of the top causes of drug withdrawals, restrictions and project terminations. DILI results when reactive metabolites – formed when certain orally administered drugs are metabolized in the liver – end up binding to cellular proteins and damaging liver cells.

While there is not yet a reliable in vitro, animal or computational model that can effectively predict DILI, we are hoping that a promising new partnership between Elsevier and the National Center for Toxicological Research (NCTR) at the FDA could eventually help lead to one. The two entered into a Collaborative Research and Development Agreement (CRADA), and have been working together since October 8, 2019.

As the press release notes, “NCTR and Elsevier began collaborating on a project to conduct research for the development of a predictive drug-induced liver injury (DILI) algorithm by integrating the rule-of-two model and preclinical data from the literature and the summary basis of FDA and European Medicines Agency (EMA) approval documents collected in Elsevier’s PharmaPendium database.”

With its status as a leading cause of liver failure, DILI poses a significant danger to patients. It also presents major problems for pharmaceutical companies that can lose billions of dollars in development costs and future earnings when DILI leads to late-stage failures. The development of a predictive model would enable pharma businesses and regulators to make more informed decisions earlier, optimize R&D efficiency, reduce costs and, most critically, improve patient safety.

It is a tribute to the high quality of PharmaPendium’s safety data that the FDA, the world’s most authoritative regulatory body, has signed on to this collaborative agreement. It also points to Elsevier’s growing reputation as a trusted predictive analytics company that is relied upon in the industry for its unique expertise.

Read the full press release here.

Aurinia to Present Preclinical Voclosporin Data at 2020 Keystone Symposia Conference
Published: 3 Dec 2019 | 0:00 UTC

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced that an abstract has been accepted for presentation at the Keystone Symposia Conference on Islet Biology: From Gene to Cell to Micro-Organ in Santa Fe, New Mexico from January 27-31, 2020.

Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine
Published: 1 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 1, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of...

The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing
Published: 29 Nov 2019 | 2:11 UTC

November 18, 2019 -- The Medicines Company (NASDAQ: MDCO) today announced detailed results from ORION-9, the last of three pivotal 18-month low-density lipoprotein cholesterol (LDL-C) lowering Phase 3 clinical studies of inclisiran, an...

Novartis Retains Top Spot in CNS Summit Innovation Index
Published: 23 Nov 2019 | 20:25 UTC

For the second year in a row Novartis has been named the most innovative pharma company in the industry by the Innovation Index, a collaboration between CNS Summit and IDEA Pharma.

Pipeline Extra: Mastering the Microbiome
Published: 18 Nov 2019 | 0:00 UTC

Over the last couple of years, personal care brand Dove has been promoting its body wash products as microbiome friendly. This being a largely unfamiliar term to the casual consumer of skincare lotions, Dove s marketing campaign adopted an explanatory tone, explaining how our skin microbiome c

Pharm Exec   s 2020 Pipeline Report
Published: 17 Nov 2019 | 0:00 UTC

From Promise to Progress Pharm Exec s 16th Annual Pipeline Report examines six key areas of biopharma R&D a mix of emerging and maturing where, for some, promising research efforts are now beginning to pay dividends, as novel advances in science usher in new treatment approac

HHS to Support Development of Infection Diagnostic Technology
Published: 14 Nov 2019 | 18:37 UTC

HHS will provide support under a 14-month, $6 million contract, which can be extended up to almost $65 million through 2027.

Elsevier uses machine learning to benefit pharmacovigilance
Published: 7 Nov 2019 | 8:30 UTC

Monitoring the scientific literature for adverse drug reactions (ADRs) is critical to maintaining drug safety, and there is no room for error. As regulations tighten, pharmacovigilance teams are seeking better strategies and methods for ensuring that all ADRs are identified in the most effective and efficient way possible.

Elsevier is providing leadership in this area in many ways, including efforts to use AI and natural language processing (NLP) technology to monitor the literature. Umesh Nandal, an Elsevier scientist who specializes in machine learning and NLP, and his team has been doing great work on the automated extraction of ADRs from biomedical literature and FDA drug labels. As a part of our outreach to the global pharmacovigilance community, I will be presenting on this work at the China Pharmacovigilance Conference in Guangzhou this month.

The presentation, which touches on the future of AI and how Elsevier is utilizing machine learning with its various information solutions, will focus on explaining various approaches for extracting ADRs and highlight a few particular projects where Elsevier is applying AI.

We are excited to be at the forefront of these developments in the use of state-of-the-art technology to meet the needs of pharmacovigilance professionals.

Closing the Science and Manufacturing Divide
Published: 7 Nov 2019 | 0:00 UTC

With pursuits of complex therapies more routine, platform companies are tasked with aligning their science with process and manufacturing proficiency to stand out in an increasingly competitive investment market When it comes to platforms, there is no separating the science fr

How to digitize the quality process and gain new insights
Published: 5 Nov 2019 | 12:20 UTC

Daniela Jansen, BIOVIA Brand Marketing Director, Dassault Systèmes, shares six steps organizations can take to improve data integrity, data quality and digitalize processes

Neural Analytics Enrolls First Subjects in Robotic Technology Trial
Published: 4 Nov 2019 | 17:03 UTC

The ultrasound device is intended to be used as an adjunct to standard clinical practices.

LivaNova Kicks Off Trial for Nerve Stimulation Therapy
Published: 1 Oct 2019 | 21:26 UTC

The FDA cleared LivaNova’s Symmetry VNS therapy system for adjunctive long-term treatment of chronic or recurrent depression in patients 18 and older.

FDA Gets Ready for ‘Data-Rich’ Future
Published: 27 Sep 2019 | 21:18 UTC

The agency aims to develop “a robust infrastructure, cloud-forward plans, clear and efficient external data interfaces, and a focus on cybersecurity.”

New Study Offers Insight into Alzheimer’s Disease Research Landscape
Published: 9 Sep 2019 | 8:30 UTC

The sixth leading cause of death in the U.S., and estimated to affect approximately 45 million people worldwide, Alzheimer’s is a progressive brain disease that causes memory loss and overall mental deterioration. Coinciding with World Alzheimer’s Month, Elsevier just released a report (which you can download here) analyzing Alzheimer’s research spanning the last 50 years in order to present a comprehensive overview of the research landscape for this irreversible condition.

Major takeaways from the report

A few key insights that came from this analysis, which we conducted using SciVal, Scopus, ScienceDirect, Pathway Studio and Elsevier Text Mining, include:

Trends in Alzheimer’s disease targets

Looking at the period from 1999 to 2018, the research on APP appears to dwarf all other protein studies. BACE1 (or β-secretase), which also appears among the top 5 protein targets studies in Alzheimer’s disease research, is involved in generation of amyloid-β peptides from APP. 

After APP, other major targets for research appear, including MAPT (microtubule-associated protein tau, which structurally stabilizes neurons), and PSEN1 and PSEN2 (subunits of γ secretase, which is involved in producing amyloid-β from APP), all of which have been posited to be involved in various aspect of Alzheimer’s disease. Other proteins in the top targets include those involved in immunity, DNA damage repair, cell death and protein modification.

What could the future of Alzheimer’s disease research look like?

Analyzing the research output over the last several decades offered a lot of insight about Alzheimer’s disease research, but what’s in store for the future?

It is my opinion that an increased focus on the molecular mechanisms involved in Alzheimer’s disease would provide immense insight. Understanding the pathological pathways involved in Alzheimer’s disease is fundamental in such a complex, multi-faceted disease. Many therapeutics are targeted at a single pathway that has a lower chance of success and is one of the reasons there are not yet any current drugs that halt, reverse or prevent Alzheimer’s disease.

Each year, more and more protein targets are implicated in Alzheimer’s disease, and without an understanding of these, it is hard to gain insight into the whole picture, which in turn could provide valuable information for drug development and treatment options.

Much of the damage caused by Alzheimer’s disease occurs before any signs or symptoms are presented by patients, so treating early or before diagnosis may be a potential avenue to explore. Looking at the disease from multiple angles (i.e. from basic science research all the way through to behavioral studies), and focusing on knowledge-sharing and lessons learned from all these fields of study, could provide the key breakthroughs needed to treat, prevent and cure this disease that devastates patients, family and friends, caregivers and society.

View Elsevier’s report Alzheimer’s disease research insights: impacts, trends, opportunities, and click here to learn more about Elsevier’s R&D Solutions for Pharma & Life Sciences.

An Effective Way to Apply AI to the Design of New Drug Lead Compounds
Published: 11 Jun 2019 | 9:45 UTC

Shahar Keinan, William J. Shipman & Ed Addison of Cloud Pharmaceuticals share their experience using AI for novel drug discovery

Is it a good time to be a data scientist in the pharmaceutical industry?
Published: 4 Jun 2019 | 11:35 UTC

We discuss how the role of data analytics is changing in the industry and what the real "value add" is

FDA Advises on Clinical Trials for Uncomplicated UTI Treatments
Published: 10 May 2018 | 17:35 UTC

Patients showing signs of systemic illness should be excluded, as well as patients being treated with other antibacterial drugs effective in treating uUTI.

FDA Advises on Clinical Trials for Uncomplicated UTI Treatments
Published: 9 May 2018 | 22:36 UTC

The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments.

Clinical Trial Management Systems Will Be $1.8 Billion Business by 2019: Report
Published: 18 Dec 2017 | 22:45 UTC

The market for clinical trial management system software is expected to be worth nearly $1.8 billion by 2019 with much of the double-digit growth taking place in developing countries, according to Persistence Market Research.

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