On January 31, 2018 Astellas reported that it has Appointed Kenji Yasukawa as President and CEO (Press release, Astellas, JAN 30, 2018, View Source [SID1234523647]).

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On January 30, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer reported that it is hosting an analyst and investor event to present Phase 2 results from its HS-110 (viagenpumatucel-L) study in combination with the Bristol-Myers Squibb checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers have progressed after treatment with one or more lines of therapy (Press release, Heat Biologics, JAN 30, 2018, View Source [SID1234523629]).

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The presentation will take place at 8 a.m., Wednesday, Feb. 28, 2018, in New York City. A live webcast will be available for those who cannot attend. The event will follow the first formalized Independent Data Monitoring Committee ("IDMC") meeting review of the most recent Phase 2 interim data from the trial.

"We are looking forward to concluding our first IDMC data review and presenting our initial Phase 2 results," said Jeff Wolf, CEO of Heat. "Our presentation will focus on clinical observations, which will help inform the best pathway to advance HS-110 through a registrational trial."

The presentation will include data generated from the first 35 patients enrolled in the study; specifically:

Clinical efficacy measures of treatment response
The correlation of immune response from blood samples with positive clinical outcome
Safety data evaluation and analysis
Key opinion leaders will also provide an overview of NSCLC and the need for combination therapies in this setting, while management will discuss company milestones for 2018 and beyond. Further, management will provide an outline of Heat’s planned development strategy for HS-110 based on the recent outcome of its Type C meeting with the FDA.

Additional details such as location, speakers and webcast information will be provided prior to the event.

On January 30, 2018 Consolidated Financial Statements for the Third Quarter Ended December 31, 2017 (Presentation, Takara Bio, JAN 30, 2018, View Source [SID1234524044]).

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On January 30, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501 have been placed on a clinical hold following three cases of encephalopathy deemed as possibly related to BPX-501 (Press release, Bellicum Pharmaceuticals, JAN 30, 2018, View Source [SID1234523650]).

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Bellicum is awaiting formal communications from the FDA to determine the requirements for resuming studies, and will be working closely with the FDA to address their questions. The FDA clinical hold does not affect the ongoing BP-004 registration trial in Europe.

Encephalopathy has been reported in the allogeneic stem cell transplant literature. Risk factors for encephalitis/encephalopathy after allogeneic stem cell transplants include prolonged immunodeficiency, selected medications, infections, and inflammatory processes such as graft versus host disease. Bellicum has treated more than 240 patients with BPX-501 cells on three allogeneic haploidentical stem cell transplantation protocols. These three cases are complex, with a number of potential confounding factors—including, in certain of the cases, prior failed transplants, prior history of immunodeficiency, concurrent infection, and administration of rimiducid in combination with other medications. Bellicum is working with FDA to evaluate the risk of encephalopathy in patients receiving BPX-501.

On January 30, 2018 Varian Medical Systems, Inc. reported Presentation: Acquisition of Sirtex (Press release, Varian Medical Systems, JAN 30, 2018, View Source [SID1234523637]).

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