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CHMP suggests AstraZeneca and Merck’s selumetinib for paediatric patients
pharmaceutical-technology
April 28, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended AstraZeneca and Merck’s (MSD) selumetinib for conditional marketing authorisation in the EU for treating children aged three years and ...
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Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS
americanpharmaceuticalreview
April 19, 2021
Merck, a leading science and technology company, will present data from a Phase II placebo-controlled randomized trial at the 2021 American Academy of Neurology (AAN) Annual Meeting showing that the investigational Bruton’s tyrosine kinase (BTK) ...
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Merck KGaA Selects PRA’s Remote Patient Monitoring Platform
contractpharma
April 09, 2021
Merck KGaA, Darmstadt, Germany, known in the U.S. as EMD Serono, has selected PRA Health Sciences’ remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system.
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Alkermes, Merck Enter Clinical Trial and Supply Agreement
contractpharma
April 08, 2021
To evaluate nemvaleukin alfa in combination with Keytruda in patients with platinum-resistant ovarian cancer.
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USFDA sends CRL to Merck’s sBLA regarding KEYTRUDA
pharmaceutical-business-review
April 02, 2021
Merck has announced that the US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) for the approval of KEYTRUDA.
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UCLA-led study identifies potential drug for Covid-19 treatment
pharmaceutical-technology
March 26, 2021
Researchers from the University of California, Los Angeles (UCLA) and universities in California, Delaware and Germany, as well as German company Merck, have identified a compound, berzosertib, which demonstrated potential in treating SARS-CoV-2 virus ...
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EMA advises against ivermectin use for Covid-19 outside clinical trials
pharmaceutical-technology
March 24, 2021
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasite drug ivermectin for the prevention or treatment of Covid-19 outside randomised clinical trials.
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Merck KGaA, Darmstadt, Germany, Reports Topline Data for Bintrafusp Alfa for Biliary Tract Cancer
americanpharmaceuticalreview
March 23, 2021
Merck KGaA, Darmstadt, Germany has announced topline data from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who ...
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Merck adds assembly production unit in France for Covid-19 vaccines
pharmaceutical-technology
March 19, 2021
Merck is adding a €25m, single-use assembly production unit at its Life Science Center (LSC) in Molsheim, France, to manufacture Covid-19 vaccines and other therapies.
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USFDA grants priority review to Merck’s NDA for HIF-2α inhibitor Belzutifan
pharmaceutical-business-review
March 17, 2021
The US Food and Drug Administration (FDA) has granted priority review for Merck’s New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan.