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Arena Pharmaceuticals to Present at the 19th Annual Needham Virtual Healthcare Conference on April 14

On April 10, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, the Company’s President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the 19th Annual Needham Healthcare Conference on Tuesday, April 14, at 10:40 AM ET (7:40 AM PT) (Press release, Arena Pharmaceuticals, APR 10, 2020, View Source [SID1234556248]).

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A live webcast of the presentation will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

GRAIL Appoints Sir Harpal Kumar as President of GRAIL Europe

On April 10, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported the appointment of Sir Harpal Kumar as President of GRAIL Europe (Press release, Grail, APR 10, 2020, View Source [SID1234556247]). In this new role, Sir Harpal will be responsible for leading GRAIL’s entry and growth in Europe.

"I am delighted to welcome Harpal to the GRAIL team. He is a passionate advocate for better outcomes in cancer, with a widely recognized appreciation of the challenges health systems face in battling the increasing burden of this disease," said Hans Bishop, Chief Executive Officer at GRAIL. "With Harpal’s leadership, we can build partnerships that will bring the benefits of early cancer detection to patients and providers in Europe.’’

"I’m thrilled to be joining GRAIL and to have the opportunity to transform cancer care through early detection," said Sir Harpal. "I look forward to leading the company’s partnerships with European medical and healthcare services and the broader innovation community to support our goal of decreasing the burden of cancer."

Sir Harpal joins GRAIL from Johnson & Johnson where he most recently served as Senior Vice President and Head of Innovation EMEA. There, he oversaw a portfolio of co-investments and collaborations across the region to grow Johnson & Johnson’s networks within the EMEA innovation community. Before joining Johnson & Johnson Innovation, Sir Harpal spent 15 years with Cancer Research UK, and served as the organization’s Chief Executive Officer from April 2007 until June 2018. Prior to this, he was Chief Operating Officer & Executive Director of Development at CRUK and served as Chief Executive of Cancer Research Technology (a subsidiary of CRUK). Before CRUK, he worked with McKinsey & Co, The Papworth Trust, and Nexan Group. Sir Harpal received a Masters in Chemical Engineering from the University of Cambridge, and an MBA as a Baker Scholar from Harvard Business School. He has been awarded Honorary Doctorates from the Universities of Manchester, Newcastle, and Glasgow, and the Institute of Cancer Research, and he is a Fellow of The Academy of Medical Sciences. In 2016, he was knighted by Her Majesty Queen Elizabeth II for services to cancer research.

Genetron Health Appoints Former FDA Senior Officer Dr. Yun-Fu Hu as Chief Medical Officer

On April 10, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company, reported the appointment of Dr. Yun-Fu Hu as Chief Medical Officer (Press release, Genetron Health Technologies, APR 10, 2020, View Source [SID1234556246]). A former deputy director with the US Food and Drug Administration (FDA), Dr. Hu will be tasked to steer the company forward in its in vitro diagnostic (IVD) devices registration and regulatory affairs as well as bio-pharmaceutical services business.

Dr. Hu has over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. During his tenure at FDA, he has led a team of staff in premarket reviews and post-market compliance of IVD products and laboratory-developed tests (LDTs) for genetic testing, molecular cancer diagnostics, companion diagnostics, radiodosimetry, digital pathology and artificial intelligence devices. Some of his notable authorizations include: the first next generation sequencing (NGS)-based LDT as companion diagnostics (CDx) (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). Dr. Hu and his team have also won over 10 FDA-level group awards for outstanding contributions in FDA authorization of many such first-of-its-kind devices.

Prior to joining FDA, Dr. Hu has more than 10 years of product development experience in diagnostic and pharmaceutical industries, leading his teams to achieve outstanding results in biomarker discovery and diagnostic development.

Sizhen Wang, Genetron Health’s co-founder and CEO, said, "Dr. Hu’s caliber and depth of experience in molecular cancer diagnostics and pharmaceutical R&D is nothing short of exceptional. Hailed with outstanding regulatory background and solid industry experience, he is a perfect hybrid talent in the global biopharmaceutical field. With Dr. Hu joining our leadership team, he will value-add to our molecular diagnostic business with international best practices in technical R&D, product design, clinical approval and policy and regulatory matters. I believe he will be an asset to Genetron Health and the industry in driving high quality and high efficiency clinical adoption of more innovative technologies."

Dr. Hu said, "China has a unique advantage in precision oncology clinical data. We have witnessed the emergence of many outstanding companies, related technologies and products in recent years. I am truly impressed with the global vision shown by the leadership at Genetron Health. I believe Genetron has massive growth potential, driven by the company’s continuous innovation capabilities. I am delighted to be part of this team and I look forward to assisting the clinical adoption of Genetron’s innovative technologies and the establishment of a global one-stop bio-pharmaceutical service platform. It is our hope to bring high quality China biotechnology to the world."

Entry into a Material Definitive Agreement

On April 10, 2020 Pelican Therapeutics, Inc. ("Pelican"), reported that it was awarded $15.2 million to fund preclinical and certain clinical activities from Cancer Prevention Institute of Texas (CPRIT) grant (the "CPRIT Grant") (Filing, 8-K, Heat Biologics, APR 10, 2020, View Source [SID1234556244]). The CPRIT Grant is subject to customary CPRIT funding conditions.

The CPRIT Grant initially covered a three-year period from June 1, 2017 through May 31, 2019. On April 12, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 31, 2019 to November 30, 2019. On November 20, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from November 30, 2019 to May 30, 2020. On April 9, 2020, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 30, 2020 to November 30, 2020. All other terms and conditions of the CPRIT arrangement remained the same.

Athenex Provides an Update on Oral Paclitaxel FDA Meeting

On April 9, 2020 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 recently participated in a constructive meeting with the U.S. Food and Drug Administration (FDA) as scheduled, to discuss the clinical section of the New Drug Application (NDA) for oral paclitaxel and encequidar for the treatment of metastatic breast cancer (Press release, Athenex, APR 9, 2020, View Source [SID1234573880]). The Company is on track to submit the NDA in accordance with the FDA’s guidance, and will provide a further update when the FDA’s official response to the filing becomes available.