Thermo Fisher Scientific to Present at the Baird 2018 Global Industrial Conference on November 7, 2018

On October 29, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Dan Shine, senior vice president and president, Analytical Instruments, will present at the Baird 2018 Global Industrial Conference on Wednesday, November 7, 2018, at 12:30 p.m. (CST) at the Four Seasons Hotel, Chicago, Ill (Press release, Thermo Fisher Scientific, OCT 29, 2018, View Source [SID1234530300]).

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You can access the live webcast of the presentation in the Investors section of our website, www.thermofisher.com.

Fate Therapeutics to Webcast Conference Call Reporting Third Quarter 2018 Financial Results

On October 29, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Thursday, November 1, 2018 at 5:00 p.m. ET to report its third quarter 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, OCT 29, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-third-4 [SID1234530298]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6998539. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event

TESARO Announces Achievement of ZEJULA Prostate Cancer Development Milestones by Janssen

On October 29, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc. (Janssen) (Press release, TESARO, OCT 29, 2018, View Source [SID1234530297]). The milestones are related to Janssen’s ongoing GALAHAD trial, which is assessing niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. Data from the trial are anticipated to support global regulatory filings in 2019.

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In addition, data from the Phase 1b BEDIVERE trial were recently presented at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) and demonstrated the safety and tolerability of combining niraparib with abiraterone acetate + prednisone (AA-P) in men with mCRPC. Data from the BEDIVERE trial will be used to inform the dosing regimen in a future Phase 3 trial that will assess the clinical benefit of niraparib in combination with AA-P in mCRPC patients.

TESARO entered into a global prostate collaboration and license agreement with Janssen in 2016, through which Janssen received rights to develop and commercialize niraparib for patients with prostate cancer worldwide, except Japan. Under the terms of the agreement, TESARO is eligible to receive development, regulatory and commercial milestones, in addition to royalty payments.

About the Janssen GALAHAD Clinical Trial
GALAHAD is an ongoing Phase 2, open-label, single arm trial designed to evaluate the safety and efficacy of niraparib monotherapy (300mg daily) in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies progressing on/after taxane-based chemotherapy and androgen receptor targeted therapy. Patients are enrolled in the study based on their DNA-repair deficiency status.

About the Janssen BEDIVERE Clinical Trial
BEDIVERE is an ongoing Phase 1b, open-label, dose-selection study with dose expansion designed to evaluate the safety of niraparib in combination with AA-P in men with metastatic castration-resistant prostate cancer (mCRPC) who may or may not have had DNA-repair anomalies.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

Protalix BioTherapeutics to Hold Third Quarter 2018 Financial Results and Corporate Update Conference Call on November 7, 2018

On October 29, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report third quarter 2018 financial results and provide a corporate update on Wednesday, November 7, 2018 at 8:30 am ET (Press release, Protalix, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373839 [SID1234530296]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8567317.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Principia Biopharma Appoints Dolca Thomas, M.D. as Chief Medical Officer

On October 29, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported the appointment of industry veteran Dolca Thomas, M.D. as its Chief Medical Officer (Press release, Principia Biopharma, OCT 29, 2018, View Source [SID1234530295]). Dr. Thomas joins Principia from Roche, where she was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease. She brings approximately 15 years of industry and medical experience to Principia. Steve Gourlay, MBBS, FRACP, Ph.D. will remain with the company as a senior medical advisor through mid-year 2019.

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"We are very excited with the addition of Dolca to the Principia team, particularly as we pursue an expanding scope of clinical development activities including initiating our pivotal Phase 3 trial for PRN1008 in patients with pemphigus. Dolca is a seasoned pharma executive with broad and successful experience in executing late stage programs, specifically in immunology," said Martin Babler, Chief Executive Officer of Principia. "I also want to thank Steve for his leadership, dedication and contributions to Principia over the past five years. Steve led the clinical development of three different molecules, including taking PRN1008 from its first-in-human trial through design and preparation for Phase 3. We are pleased that he will continue to support the company as a senior medical advisor through the first half of next year."

"I am impressed with Principia’s approach to BTK inhibition in autoimmune disease and believe that application of the company’s proprietary Tailored Covalency platform may be applicable across a wide range of autoimmune and inflammatory conditions," said Dr. Thomas. "I have been involved in more than a dozen immunology product candidates, and I look forward to contributing to the potential success of Principia’s pipeline assets and moving the company towards late-stage clinical development."

Dr. Thomas brings 15 years of industry and medical experience with strategic and operational responsibility for clinical development, pharmacovigilance, and safety and medical affairs of approximately two dozen pharmaceutical products. Most recently, Dr. Thomas was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease at Roche, where she was responsible for advancing multiple product candidates through clinical development. Prior to Roche, Dr. Thomas held roles of increasing responsibility at Pfizer, including Vice President of Clinical Development and Clinical Immunophenotyping, and Vice President and Chief Development Officer of the Biosimilars Research and Development Unit where she was responsible for all stages of development of multiple assets. Dr. Thomas began her industry career at Bristol-Myers Squibb as Director of Global Clinical Development in Immunology, where she was involved in the development and approval of belatacept.

Dr. Thomas has a B.A. in sociology from Cornell University, and received her M.D. degree from Cornell University. Dr. Thomas completed her residency in internal medicine, in addition to her post-doctoral training in nephrology and transplantation, at New York- Presbyterian Hospital, Weill Cornell Medical Center.

Dr. Thomas represented both Bristol-Myers Squibb and Pfizer on the Board of Directors of the Progressive Multifocal Leukoencephalopathy (PML) Consortium, a cross-industry consortium aimed at identifying more effective methods of predicting, preventing, and developing future treatments for PML. Dr. Thomas has many past collaborations with the Juvenile Diabetes Research Foundation (JDRF) where she has been the recipient of multiple JDRF research grants and awards. In addition, she served on Board of Directors for the NYC JDRF chapter.