On November 21, 2017 Celgene Corporation (NASDAQ: CELG) reported that it plans to webcast an analyst and investor event being held at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Atlanta on December 10 (Press release, Celgene, NOV 21, 2017, View Source [SID1234522188]). The webcast will begin at 8pm ET and will be available in the Investor Relations section of the Company’s website at www.celgene.com.

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On November 21, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA) (Press release, Genmab, NOV 21, 2017, View Source [SID1234522194]). This application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX) to include use in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The submission of the application triggers milestone payments totaling USD 3 million to Genmab from Janssen. The milestone payments were included in Genmab’s financial guidance for 2017, which was published on November 14, 2017. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are very pleased about this submission, which marks the first application for the use of daratumumab for patients with newly diagnosed multiple myeloma. We look forward to working with both Janssen and the EMA so that daratumumab can potentially become available for a broader group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. This data will also be used as the basis for a potential regulatory submission to the U.S. Food and Drug Administration.

On November 21, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, NOV 21, 2017, View Source [SID1234522192]). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are extremely pleased that submissions have now been made in both the U.S. and Europe for daratumumab to treat patients with newly diagnosed multiple myeloma. We believe these submissions exemplify the further potential of daratumumab, and we look forward to working with both Janssen and the FDA to bring DARZALEX to a wider group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted within the next 60 days. If the FDA grants Priority Review, the review should be completed within 6 months from today.

The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. Janssen also submitted a Type II variation application for daratumumab in this indication to the European Medicines Agency (EMA).

On November 21, 2017 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Scott Wolchko, President and Chief Executive Officer, will present at the 2017 Piper Jaffray Healthcare Conference in New York on Tuesday, November 28, 2017 at 12:50 p.m. ET (Press release, Fate Therapeutics, NOV 21, 2017, View Source [SID1234522191]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcast, an archived replay will be available on the Company’s website.

On November 21, 2017 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that Ron Cohen, M.D., Acorda’s President and CEO, will present at the Piper Jaffray Healthcare Conference in New York on Tuesday, November 28, 2017 at 1:00 p.m. ET (Press release, Acorda Therapeutics, NOV 21, 2017, View Source [SID1234522190]).

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A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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