Tag Archives: Merck KGaA

December, 2018

26 December
Merck KGaA and Pfizer to Terminate Late-Stage Avelumab Trial in Previously-Untreated Advanced Ovarian Cancer

Darmstadt, Germany, and New York, US, December 21, 2018 – Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab* did not support the study’s initial hypothesis, and therefore the alliance made …
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13 December
FDA Grants Orphan Drug Designation to Merck KGaA’s Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

DARMSTADT, Germany, December 10, 2018 /PRNewswire/ — FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer First regulatory designation for M7824 following recent presentation of first clinical data in BTC BTC is a group of rare, aggressive gastrointestinal cancers associated with limited treatment options and …
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19 November
Avelumab Fails to Meet Primary Endpoints in Late-Stage Platinum-Resistant/Refractory Ovarian Cancer Trial

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free …
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16 November
Immunicum Collaborates with Merck KGaA and Pfizer to Evaluate Ilixadencel in Combination with Avelumab in Multi-Indication Phase Ib/II Study

Immunicum AB (publ; IMMU.ST) announced today that it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate its lead product, ilixadencel, an off-the-shelf cell-based cancer immune primer, in combination with avelumab*, a human anti-PD-L1 monoclonal antibody, in a planned multi-indication Phase Ib/II clinical trial. …
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19 September
ITM and Merck KGaA Sign Research Evaluation and Option Agreement to Develop Folate Receptor Targeted Radionuclide Therapy

GARCHING, Germany–(BUSINESS WIRE)–Isotopen Technologien München AG (ITM), a group of specialized radiopharmaceutical companies, announced today that it has signed a Research Evaluation and Option Agreement for a worldwide exclusive license with Merck KGaA, Darmstadt, Germany. Merck KGaA is a global leader for the development and manufacturing of active pharmaceutical ingredients …
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27 December
HTG Molecular Diagnostics Expands Collaboration with Merck KGaA

TUCSON, Ariz. and DARMSTADT, Germany, Dec. 26, 2017 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents and services for molecular profiling applications today announced a new Master Collaboration Agreement for translational programs with Merck KGaA, Darmstadt, Germany, a leading science and technology company. The Master Collaboration …
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21 December
FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma

DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ — Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] Javelin Renal clinical development program is ongoing, including Phase III first-line study Merck and …
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28 November
Pfizer and Merck KGaA’s Avelumab Fails to Meet Primary Endpoint in Late-Stage Gastric Cancer Trial

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab* compared with physician’s choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable, recurrent …
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9 May
FDA Approves Pfizer’s Bavencio for Treatment of Patients with Advanced Bladder Cancer

ROCKLAND, Mass. and NEW YORK, May 9, 2017 /PRNewswire/ — EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of patients …
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3 April
Intrexon, Ziopharm and Merck KGaA Provide Update on the Development of their CAR-T Therapy

GERMANTOWN, Md. and BOSTON, April 03, 2017 (GLOBE NEWSWIRE) — Intrexon Corporation (NYSE:XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, ZIOPHARM Oncology (NASDAQ:ZIOP), a biopharmaceutical company focused on new immunotherapies, and Merck KGaA, Darmstadt, Germany, a leading …
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