AOP Orphan announces progress of its European Marketing Authorization Procedure of Ropeginterferon alfa-2b

On June 11, 2018 AOP Orphan´s reported that submission for marketing authorization of Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) in the European Union (EU) has resumed after clock-stop (Press release, AOP Orphan Pharmaceuticals, JUN 11, 2018, View Source [SID1234527280]). The conclusion of this centralized procedure is expected for Q4/2018.

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Interferons (IFNs) have been successfully applied in various hematological malignancies including PV, Chronic Myeloid Leukemia (CML) and other myeloproliferative neoplasms (MPNs) for about three decades, however no IFN has obtained regulatory approval in these indications yet.

Ropeginterferon alfa-2b is the first monopegylated IFN with an improved application of only once every two weeks (and only once per month in long-term maintenance treatment). The innovative pegylation technology and the molecule have been invented by PharmaEssentia Corporation (Taiwan Stock Exchange: 6446), a long-term partner of AOP Orphan.

In 2009, AOP Orphan has in-licensed from PharmaEssentia Corporation the exclusive rights to develop and commercialize Ropeginterferon alfa-2b in PV, CML and other MPNs for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

Since 2009, AOP Orphan´s Development Program in PV including the phase I/II trial PEGINVERA and the phase III trials PROUD-PV, PEN-PV and CONTINUATION-PV, have established high efficacy and favorable safety and tolerability of Ropeginterferon alfa-2b in PV. PharmaEssentia Corporation has invested in preparations for commercialization of the drug in its territory and in the capability for commercial manufacturing of the drug. The company´s world-class cGMP biologics facility in Taichung is certified by the Taiwan Food and Drug Administration (TFDA) and since 2018 also by EMA , and it is designed and operated to be compliant with all U.S. FDA requirements.

Commercial availability of Ropeginterferon alfa-2b is expected to fulfill an increasing need of patients and physicians for the long-term management of a yet incurable class of diseases.

Varian Announces Third Quarter Fiscal Year 2018 Earnings Release Date

On June 11, 2018 Varian (NYSE: VAR) reported that it will report results for the third quarter of fiscal year 2018 after market close on Wednesday, July 25, 2018 (Press release, Varian Medical Systems, JUN 11, 2018, View Source [SID1234527266]). The news release will be followed by a teleconference available to all interested at 2:00 p.m. Pacific Time. To access the teleconference call and replay:

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Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13680748. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, July 27, 2018.

Five Prime Therapeutics to Present at Goldman Sachs 39th Annual Global Healthcare Conference

On June 11, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the Goldman Sachs 39th Annual Global Healthcare Conference, June 14, 2018, at 8:00 am PT (Press release, Five Prime Therapeutics, JUN 11, 2018, View Source [SID1234527265]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

Clovis Oncology to Present at the Goldman Sachs 39th Annual Global Healthcare Conference 2018

On June 11, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the Goldman Sachs 39th Annual Global Healthcare Conference onTuesday, June 12, 2018 at 4:00 PM Pacific Time (Press release, Clovis Oncology, JUN 11, 2018, View Source [SID1234527264]). The conference will be held at the Terranea Resort in Rancho Palos Verdes, CA.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Bristol-Myers Squibb to Take Part in Goldman Sachs 39th Annual Global Healthcare Conference

On June 11, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in Goldman Sachs 39th Annual Global Healthcare Conference on Wednesday, June 13, 2018, in Rancho Palos Verdes, CA (Press release, Bristol-Myers Squibb, JUN 11, 2018, View Source [SID1234527263]). Johanna Mercier, Head of U.S. Commercial, and Fouad Namouni, Head of Oncology Development, will answer questions about the company at 6:20 p.m. ET (3:20 p.m. PT).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.