BAVENCIO® (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

15-May-2019

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a ...

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20-Dec-2018

GlaxoSmithKline plc has reached agreement with Pfizer Inc to combine their consumer health businesses into a new Joint Venture, with combined sales of approximately £9.8 billion ($12.7 billion). GSK will have a majority controlling equity interest of 68% and Pfizer will have an equity interest of ...

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Initial launches planned in Germany and the UK

22-Sep-2017

Merck and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing ...

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Decision by the EC is expected in the third quarter of 2017

25-Jul-2017

Merck and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab (BAVENCIO®) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and ...

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21-Jul-2017

Merck & Co., Pfizer and Corning Incorporated announced collaborations that have enabled the modernization of pharmaceutical packaging with the introduction ofCorning Valor™ Glass. This revolutionary pharmaceutical glass packaging solution enhances the storage and delivery of today’s drug ...

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First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma

24-Mar-2017

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved ...

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Avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma

30-Nov-2016

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab, which was submitted by EMD Serono, the biopharmaceutical business of Merck in the US and Canada. This review relates to avelumab’s ...

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Approval for adults age 18 through 49

14-Jul-2016

Pfizer Inc. announced that Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for ...

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08-Jul-2016

Merck and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III ...

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Data featured contributes to growing understanding of the potential role of avelumab in treating a broad range of cancers

20-May-2016

Merck and Pfizer announced that avelumab presentations across seven different tumor types, including two oral presentations, will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting. The avelumab presentations, from the rapidly accelerating JAVELIN clinical development ...

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