On February 26, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its 6-month study on storage of the frozen encapsulated cells necessary for the determination of an "initial shelf life" has been successfully completed by Austrianova (Press release, PharmaCyte Biotech, FEB 26, 2018, View Source [SID1234524167]). This work involved the removal of samples of encapsulated cells from -80o Celsius (C) storage at various intervals up to six months, thawing the encapsulated cells and testing them for various functional parameters as well as for sterility.

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Regulatory agencies, including the U.S. Food and Drug Administration (FDA), require that studies be conducted to determine an initial shelf life for a medicinal product before an advanced phase clinical trial can begin. This shelf life can then be extended with further testing as the product is being used in the clinical trial. Austrianova Singapore already has data demonstrating storage life of frozen encapsulated cells for over six years; however, these studies were done with a slightly different cell line than the cell line that will be used for PharmaCyte’s planned clinical trial. The current completed study uses the Research Bank of cells that will be used in the final product for PharmaCyte’s trial and from which Eurofins has already generated PharmaCyte’s Master Cell Bank.

The stability test results show that there are no significant changes in the viability or the enzymatic activity of the cells upon thawing after a 6-month storage period at -80oC. These results will allow an initial shelf life of six months to be set for the product; this will be extended as the product is tested further.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We are pleased with this significant result which will enable us to apply to the FDA for an initial shelf life of six months. This study, one of many being performed for us by Austrianova, is an essential part of the Investigational New Drug Application (IND) that we will be submitting to the FDA."

PharmaCyte is working on an IND to submit to the FDA so that it can begin a clinical trial involving locally advanced, inoperable, non-metastatic pancreatic cancer and expects to submit its IND later this year.

On February 26, 2018 AbbVie (NYSE: ABBV) reported that it will participate in the Barclays Global Healthcare Conference on Thursday, March 15, 2018. Bill Chase, executive vice president and chief financial officer, will present at 8 a.m. Central time (Press release, AbbVie, FEB 26, 2018, View Source [SID1234524160]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 26, 2018 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that Reshma Kewalramani, M.D., has been appointed Chief Medical Officer and Executive Vice President, Global Medicines Development and Medical Affairs, effective April 1, 2018 (Press release, Vertex Pharmaceuticals, FEB 26, 2018, View Source [SID1234524171]). Dr. Kewalramani currently serves as Senior Vice President, Clinical Development and Medical Affairs at Vertex and will succeed Jeffrey A. Chodakewitz, M.D., who is retiring from his role as Chief Medical Officer and Executive Vice President, Global Medicines Development and Medical Affairs. Dr. Chodakewitz will remain with Vertex as a senior advisor through early 2019.

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Since joining Vertex in 2014, Dr. Chodakewitz has been an inspirational senior medical leader and has played an instrumental part in the company’s advances in cystic fibrosis (CF) and in expanding Vertex’s development pipeline. Prior to Vertex, Dr. Chodakewitz had an outstanding 20-year career at Merck, where he led the successful development of multiple medicines and vaccines across a number of therapeutic areas.

"I would like to personally thank Jeff for his leadership and dedication to improving the lives of people with cystic fibrosis and other serious and life-threatening diseases," said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. "He has played a critical role in leading multiple successful clinical development efforts at Vertex, and I’m pleased that we will continue to benefit from his guidance as a senior advisor over the next year as he transitions to retirement. I’m also delighted that Reshma has agreed to succeed Jeff as our Chief Medical Officer. Reshma’s depth of medical knowledge, paired with her experience and proven track record as a clinical leader at Vertex, makes her an ideal successor to Jeff. I look forward to working with Reshma to continue to advance our clinical development pipeline in cystic fibrosis and other serious diseases."

"It has been an honor to lead Vertex’s clinical development efforts and to be a part of the significant advancement in treatments for cystic fibrosis patients over the last four years," said Dr. Chodakewitz. "I have enjoyed working closely with Reshma since she joined the Company last year and am confident that Vertex will continue its success in pursuing innovative therapies under her leadership."

"It’s a privilege to work at a company with such a relentless focus on science and deep commitment to improving the lives of patients and their families," said Dr. Kewalramani. "I am excited to assume the role of CMO and continue our important work to help more people with cystic fibrosis and other serious diseases alongside the talented team at Vertex."

Dr. Kewalramani is an accomplished leader and physician who has a track record of building strong teams, putting patients first, leading change and delivering results. Prior to joining Vertex in February 2017, Dr. Kewalramani spent over 12 years at Amgen where she most recently served as Vice President and Head of the U.S. Medical Organization. During her tenure at Amgen, Dr. Kewalramani held roles with increasing responsibility across Clinical Development and Medical Affairs and served in leadership positions involving research and development and commercialization activities across a variety of therapeutic areas. Dr. Kewalramani is the industry representative to the Food and Drug Administration (FDA) Endocrine and Metabolic Drug Advisory Committee and was on the inaugural Board of Directors of the Kidney Health Initiative. She completed her internship and residency in Internal Medicine at the Massachusetts General Hospital and her fellowship in Nephrology at the Massachusetts General Hospital and Brigham and Women’s Hospital combined program. Dr. Kewalramani received her medical degree, with honors, from the Boston University School of Medicine and is also an alumnus of the Harvard Business School.

Eagle Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Eagle Pharmaceuticals, 2018, FEB 26, 2018, View Source [SID1234524203]).

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On February 26, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release fourth quarter and full year 2017 earnings results on March 26, 2018 (Press release, Athenex, FEB 26, 2018, View Source;p=RssLanding&cat=news&id=2334562 [SID1234524161]). The Company will host a conference call and audio webcast on Monday, March 26, 2018 at 9:00 a.m. Eastern Time.

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To participate in the call, dial (855) 227-0567 (domestic) or (612) 979-9912 (international) fifteen minutes before the conference call begins and reference the conference passcode 4156727. A replay will be available approximately one hour after the recording through Monday, April 2, 2018 and can be accessed by dialing (855) 859-2056. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until April 26, 2018.