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MedNess: bite-size biopharma and medtech news
11th June , 2019
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FDA authorizes the marketing of the first diagnostic test to detect prosthetic joint infection

“Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery. Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test, they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints.”
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”
FDA approves Emgality for the treatment of episodic cluster headache
“Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients.”
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Eli Lily expands its pain management portfolio by licensing Centrexion’s non-opioid pain drug
Eli Lily announced a licensing agreement with Centrexion Therapeutics for its program CNTX-0290 focused towards developing small molecule for chronic pain conditions. The small molecule targets the somatostatin receptor type 4 (SSTR4) agonist and is currently in phase 1 clinical testing.  The agreement includes an upfront payment of $47.5M with eligibility for up to additional $575M in potential development and regulatory milestones. If the drug is commercialized then Centrexion would be eligible for up to $375M in potential sales milestones and tiered royalties.
Thrive launches with $110M for early cancer detection in liquid biopsies

Thrive is launched with $110M raised in series A for early detection of cancer using the technology CancerSEEK developed at John Hopkins University. CancerSEEK analyzes eight tumor specific gene mutations in circulating tumor DNA and cancer associated protein biomarkers in blood that are common across multiple cancer types. Based on the findings published in Science in 2018, the test has shown greater than 99% specificity and sensitivity between 33% to 98% for breast cancers and ovarian cancers respectively. Thrive plans to draw upon the demographic and phenotypic information and use machine learning to develop cost-effective solutions by early detection of cancer.
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Editors' Desk
Richa Tewari, PhD
Oncology News
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
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Ananda Ghosh, PhD
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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