Navidea Biopharmaceuticals Appoints Dr. Michael Rosol as Chief Medical Officer

On November 29, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the appointment of Michael Rosol, PhD as Chief Medical Officer of Navidea, effective December 17, 2018 (Press release, Navidea Biopharmaceuticals, NOV 29, 2018, View Source [SID1234531746]). Dr. Rosol brings to this position over 10 years of experience in biomedical imaging and commercialization.

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"We are pleased for Dr. Rosol to join Navidea and bring his deep insights into the needs of the industry for the development, validation and implementation of imaging biomarkers in clinical trials," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "He brings a wealth of knowledge and extensive experience to Navidea as we move forward with advancing our novel pipeline of imaging products and bringing products to market."

"I am excited to join Navidea as Chief Medical Officer at a key stage in the advancement of Navidea’s business," commented Dr. Rosol. "I look forward to working with the leadership team to develop innovative immunodiagnostic agents and immunotherapeutics that can meaningfully improve the lives of patients living with devastating conditions."

Prior to joining Navidea, Dr. Rosol served as Associate Director in the Clinical and Translational Imaging Group at Novartis Institutes for BioMedical Research from November 2016 to December 2018. Before that, he held positions as Senior Director of Business Development at Elucid Bioimaging, Inc. where he drove adoption of its Computer-Aided Phenotyping applications from May 2016 to November 2016, and as Chief Scientific Officer of MediLumine, Inc. from October 2015 to May 2016. Prior to those roles, he was the Head of the Translational Imaging Group at Novartis Pharmaceuticals Group from October 2012 to March 2015. His training and experience lie in the fields of biophysics, physiology, and biological/medical imaging, and his work has focused on cardiovascular imaging, preclinical and clinical imaging instrumentation and applications, animal models of human disease, pathophysiology, biomarkers, and imaging in toxicological and clinical trials. He has also served as faculty in Radiology and Director of two academic research imaging facilities. Dr. Rosol holds a PhD from Boston University School of Medicine.

Bristol-Myers Squibb to Take Part in Citi 2018 Global Healthcare Conference

On November 29, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Citi 2018 Global Healthcare Conference on Thursday, December 6, 2018 in New York (Press release, Bristol-Myers Squibb, NOV 29, 2018, View Source [SID1234531711]). Tom Lynch, chief scientific officer, will answer questions about the company at 2:10 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Innovent Announces Global Collaboration with Hutchison MediPharma to Evaluate Combination of Sintilimab and Fruquintinib in Solid Tumors

On November 29, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that it, through its wholly-owned subsidiary, Innovent Biologics (Suzhou) Co., Ltd, has entered into a global collaboration agreement with Hutchison China MediTech Limited (Chi-Med), through its Innovation Platform subsidiary Hutchison MediPharma Limited ("Hutchison MediPharma"), to evaluate the safety and tolerability of Innovent’s sintilimab in combination with Hutchison MediPharma’s fruquintinib in patients with advanced solid tumors (Press release, Innovent Biologics, NOV 29, 2018, View Source [SID1234531730]).

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Under the terms of the agreement, Innovent and Hutchison MediPharma will jointly explore potential application of this combination in solid tumors with global unmet medical needs through development efforts both in the US and in China.

"We are two leading China-based biopharmaceutical companies, one specialized in small molecules and another in large molecules; and we share the same vision of bringing China-originated mainstream anti-cancer therapies to global patients by combining our expertise and resources," said Dr. Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "There is strong scientific evidence supporting synergistic effects of PD-1 therapy when used in combination with VEGFR inhibitor. In addition, we hope to benefit from recent regulatory changes in China that allow for the recognition of foreign clinical trial data to possibly expedite the path to a China launch. We are very pleased to partner with Chi-Med to co-develop this novel combination therapy for global patients".

About Sintilimab

Sintilimab (IBI308) is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.

About Fruquintinib

Fruquintinib (brand name: Elunate) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. It was first approved for CRC in China in September 2018. It is in late-stage clinical trials, including in combination with paclitaxel (Taxol) in gastric cancer.

Elunate (fruquintinib capsules) is approved for use in China for the treatment of metastatic colorectal cancer ("CRC") with the approved dose in CRC being 5mg orally once per day, on a three-weeks-on / one-week-off cycle. It will be made available in the market in both 1mg and 5mg capsule packages. Pursuant to a collaboration agreement, Eli Lilly and Company ("Lilly") has full responsibility and authority for commercialization for Elunate in China.

Moleculin Announces New Data Further Supporting Its Lead Drug for Treating Pancreatic Cancer

On November 28, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that data from an independent test in animal models confirmed, as previously believed, that its immuno-stimulating STAT3 inhibitor achieves disproportionately high accumulation in the pancreas (Press release, Moleculin, NOV 28, 2018, View Source [SID1234531674]).

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"Our own sponsored research suggested that WP1732 might be an ideal candidate for treating pancreatic cancer," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "Now, we have independent testing with radiolabeled drug confirming this in animal models. The propensity for such enhanced pancreatic distribution could be highly beneficial for a new pancreatic cancer drug."

Walter Klemp, Moleculin’s Chairman and CEO added, "Published research shows that the growth and survival of pancreatic cancer requires activated STAT3 (p-STAT3) and our own research suggests that WP1732 may be one of the most effective inhibitors of p-STAT3 that has demonstrated activity in in vivo models. Confirming the disproportionately high accumumulation of WP1732 in the pancreas puts us one step closer to introducing an entirely new approach to treating pancreatic cancer. This is very encouraging and confirms the direction that Moleculin has taken with WP1732. We are heavily engaged in preparing the data necessary for an Investigational New Drug (IND) application with the FDA which we are targeted to file in 2019."

Amgen To Webcast Investor Call At ASH 2018

On November 28, 2018 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition on Monday, Dec. 3, 2018, at 8 p.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, together with other members of Amgen’s management team and a clinical investigator, will participate to discuss data presented at ASH (Free ASH Whitepaper) and the Company’s oncology program, including the bispecific T Cell engager (BiTE) immuno-oncology platform (Press release, Amgen, NOV 28, 2018, View Source;p=RssLanding&cat=news&id=2378592 [SID1234531714]).

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Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.