Merck & Co

Merck to acquire Rigontec

Wednesday, September 6, 2017

Merck, known as MSD outside the U.S. and Canada, will acquire Rigontec. Rigontec is a pioneer in accessing the retinoic acid-inducible gene I (RIG-I) pathway, part of the innate immune system, as a novel and distinct approach in cancer immunotherapy to induce both immediate and long-term anti-tumor immunity. Rigontec’s lead candidate, RGT100, is currently in phase I development evaluating treatment in patients with various tumors. Under the terms of the agreement, Merck, through a subsidiary, will make an upfront cash payment of €115 million to Rigontec’s shareholders; based on the attainment of certain clinical, development, regulatory and commercial milestones, Merck may make additional contingent payments of up to €349 million. The transaction is subject to certain closing conditions.

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FDA halts two multiple myeloma Keytruda trials

Tuesday, September 5, 2017

Based on data from two recently halted clinical trials, the FDA is issuing this statement to inform the public, healthcare professionals and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

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Merck receives FDA approval of new HIV-1 treatment

Tuesday, May 30, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.

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Three Questions: Dawn M. Furey, Merck & Co.

Tuesday, February 21, 2017

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Barbara M. Bolten spoke with Dawn M. Furey, executive director, head of Global Operations, Global Clinical Trial Operations, Merck & Co. Furey leads the global alignment of strategies for implementation of clinical trial operations with a focus on trial feasibility and allocation, trial site documentation, enrollment/retention planning and support of project delivery. She also led the implementation of a cloud-based electronic trial master file solution, Veeva Vault eTMF.

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Report: API market size worth $239.8B by 2025

Tuesday, January 24, 2017

The global active pharmaceutical ingredients (API) market is expected to reach a value of $239.8 billion by 2025, based on a new report by Grand View Research. The rising prevalence of lifestyle-induced & age-related diseases and cancer is projected to drive the market over the forecast period. Advancements in recombinant molecular technologies and high capitalization for development of novel drugs are also estimated to boost growth. 

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Sanofi Pasteur, Merck & Co end joint vaccines business in Europe

Thursday, January 5, 2017

Sanofi and its vaccines global business unit Sanofi Pasteur confirmed the end of their vaccine joint-venture with MSD (known as Merck & Co., in the United States and Canada), Sanofi Pasteur MSD (SPMSD). Sanofi Pasteur and MSD will separately pursue their own vaccine strategies in Europe, integrating their respective European vaccines business into their operations. The change in operations took effect January 1, 2017.

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Agilent Technologies receives expanded FDA approval to inform treatment in non-small cell lung cancer (NSCLC)

Thursday, October 27, 2016

Agilent Technologies Inc. announced that its Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration (FDA) for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer (NSCLC) with KEYTRUDA® (pembrolizumab). This expanded intended use now allows the PD-L1 IHC 22C3 pharmDx test to detect PD-L1 expression in a broader range of patients–those with a PD-L1 tumor proportion score (TPS) of 1 percent or more.

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Advaxis initiates combination portion of phase I/II study with Merck & Co.

Monday, October 24, 2016

Advaxis, clinical stage biotechnology company developing cancer immunotherapies, has announced the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis’ Lm immunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). In Part A of the phase I/II study, 14 patients were treated with ADXS-PSA monotherapy across three dose levels, with no dose limiting toxicities, paving the way for initiating Part B of the study.

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NIH award expands landmark Alzheimer’s biomarker study

Tuesday, September 13, 2016

The Alzheimer’s Disease Neuroimaging Initiative (ADNI)—the long-running NIH-supported study investigating brain and fluid biomarkers of the disease—enters a new phase of discovery with the launch of ADNI3. With the recent NIH award of approximately $40 million over the next five years—coupled with anticipated private sector contributions of $20 million through the Foundation for the National Institutes of Health (FNIH)—ADNI3 will use cutting-edge technologies in brain imaging as it recruits hundreds of new volunteers. Expansion of the groundbreaking study, now in its 12th year, will further develop ways to speed clinical trials by providing researchers the biomarkers needed to detect the onset and track the progression of Alzheimer’s disease.

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