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Merck ’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study
Dateline City: KENILWORTH, N.J. Results to be Presented at Future Medical Meeting, and Regulatory Submissions Planned for 2016 KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced top-line results from the company ’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS ® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. Language: English Contact: For Mer...
Source: Merck.com - Research and Development News - February 22, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK ISENTRESS NYSE:MRK Source Type: news

Merck Animal Health Receives FDA Approval of BRAVECTO ® (fluralaner topical solution) for Cats and Dogs
Dateline City: MADISON, N.J. Topical Treatment for Fleas and Ticks Effective for up to 12 Weeks MADISON, N.J.--( BUSINESS WIRE )--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, today announced the U.S. Food and Drug Administration ’s approval of BRAVECTO ® (fluralaner topical solution) for both cats and dogs, a topical treatment for fleas and ticks effective for up to 12 weeks 1,2 following a single dose. Language: English Contact: Merck Animal Health Media: Kelly Goss, 913-558-6452 kelly.goss@merck.com or Pamela Eis...
Source: Merck.com - Corporate News - July 21, 2016 Category: Pharmaceuticals Tags: Corporate News Animal Health Latest News #Merck #MRK $MRK Bravecto Merck Animal Health MSD Source Type: news

Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile ( C. difficile ) infection recurrence. Language: English Contact: Merck Media: Pamela Eisele, 267-305-3558 Robert...
Source: Merck.com - Corporate News - July 21, 2016 Category: Pharmaceuticals Tags: Corporate News Latest News #Merck #MRK $MRK Bezlotoxumab MSD NYSE:MRK Source Type: news

Merck Receives CHMP Positive Opinion for KEYTRUDA ® (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Dateline City: KENILWORTH, N.J. Opinion Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival Compared to Chemotherapy in Previously-Treated Patients Whose Tumors Express PD-L1 KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), the company ’s anti-PD-1 therapy, for the treatment of locally advanced or ...
Source: Merck.com - Corporate News - June 27, 2016 Category: Pharmaceuticals Tags: Oncology Newsroom Corporate News Latest News #Merck #MRK $MRK Keytruda MSD NSCLC NYSE:MRK Source Type: news

Systematic Review of 58 Publications of Real-World Use of GARDASIL ® Presented at EUROGIN Congress
Dateline City: KENILWORTH, N.J. Studies Published over the Last 10 Years Report Reductions in Cervical Pre-cancers and Other HPV-related Diseases KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced today that in a systematic review conducted of the global impact and effectiveness of GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], substantial reductions were observed in HPV 6/11/16/18-related infection, genital warts, Pap abnormalities and cervical pre-cancers. Langu...
Source: Merck.com - Corporate News - June 16, 2016 Category: Pharmaceuticals Tags: Vaccine News Corporate News Latest News #Merck #MRK $MRK EUROGIN Gardasil MSD NYSE:MRK Source Type: news

Merck Receives Positive CHMP Opinion for ZEPATIER ™ (elbasvir and grazoprevir) in the European Union
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER ™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. The CHMP positive opinion will be reviewed by the European Commission. Language: Englis...
Source: Merck.com - Corporate News - May 27, 2016 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Corporate News Latest News #Merck #MRK $MRK MSD ZEPATIER Source Type: news

Blog: Are your patient re-using insulin pen device needles?
I must have been naive, not realising that so many are doing just this. Do they think they are saving the NHS money by re-using the needles on their insulin pen devices? Hide related content:   Show related content read more
Source: Nursing in Practice - July 22, 2016 Category: Nursing Authors: Kerrie Schofield Tags: Diabetes Blogs Source Type: news

Data for Merck ' s Investigational Once-Daily Formulation of ISENTRESS ® (raltegravir) Show That at Week 48, a Regimen Containing the Once-Daily Dosing Formulation...
Dateline City: KENILWORTH, N.J. Resulted in Non-Inferior Efficacy and Safety to a Regimen Containing the Approved Twice-Daily Formulation EMA Accepts File Application, Plans Underway to Submit for Licensure to FDA This Year KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced efficacy and safety data in previously untreated adults with HIV-1 infection for the company ’s investigational once-daily formulation of ISENTRESS ® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg), from the on...
Source: Merck.com - Research and Development News - July 22, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK HIV ISENTRESS MSD NYSE:MRK Source Type: news

Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced two regulatory milestones for the company ’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME ( PRI ority ME dicines) status. Language: English Contact: Merck Media: Pamela Eisele, 267-305-3558 Skip Irvine, 2...
Source: Merck.com - Corporate News - July 25, 2016 Category: Pharmaceuticals Tags: Ebola Newsroom Corporate News Latest News #Merck #MRK $MRK MSD Source Type: news

Merck Announces Fourth-Quarter 2016 Dividend
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has declared a quarterly dividend of $0.46 per share of the company ’s common stock for the fourth quarter of 2016. Payment will be made on Oct. 7, 2016 to shareholders of record at the close of business on Sept. 15, 2016. About Merck Language: English Contact: Merck Media: Lainie Keller, 908-236-5036 or Investors: Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Source: Merck.com - Corporate News - July 26, 2016 Category: Pharmaceuticals Tags: Corporate News Financial News Latest News #Merck #MRK $MRK Dividend MSD Source Type: news

Merck Announces Second-Quarter 2016 Financial Results
Dateline City: KENILWORTH, N.J. Second-Quarter 2016 Worldwide Sales Were $9.8 Billion, an Increase of 1 Percent, Including a 2 Percent Negative Impact from Foreign Exchange Second-Quarter 2016 GAAP EPS Was $0.43; Second-Quarter Non-GAAP EPS Was $0.93 Company Updates EPS Guidance: Full-Year 2016 GAAP EPS Range to be Between $1.98 and $2.08; Full-Year 2016 Non-GAAP EPS Range of $3.67 to $3.77 Advanced KEYTRUDA Development Program KEYTRUDA Demonstrated Superior Progression-Free Survival and Overall Survival Compared to Chemotherapy in Patients with Previous...
Source: Merck.com - Corporate News - July 29, 2016 Category: Pharmaceuticals Tags: Corporate News Financial News Latest News #Merck #MRK $MRK earnings MSD NYSE:MRK Source Type: news

Tablet Splitting of Antiepileptic Drugs in Pediatric Epilepsy: Potential Effect on Plasma Drug Concentrations.
CONCLUSIONS: Splitting adult-dosage formulations of AEDs results in patients not receiving the optimal dose. Plasma drug concentrations are also not optimal. Pediatric dosage formulations should be preferred to splitting adult-dosage formulations in pediatric epilepsy. PMID: 27704404 [PubMed - as supplied by publisher]
Source: Paediatric Drugs - October 4, 2016 Category: Pediatrics Authors: Nidanapu RP, Rajan S, Mahadevan S, Gitanjali B Tags: Paediatr Drugs Source Type: research

Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma.
CONCLUSIONS: An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P. PMID: 29247424 [PubMed - as supplied by publisher]
Source: Paediatric Drugs - December 15, 2017 Category: Pediatrics Authors: Yu Y, Jia L, Meng Y, Hu L, Liu Y, Nie X, Zhang M, Zhang X, Han S, Peng X, Wang X Tags: Paediatr Drugs Source Type: research

A Review of the New Antiepileptic Drugs for Focal-Onset Seizures in Pediatrics: Role of Extrapolation.
Abstract Most antiepileptic drugs (AEDs) receive regulatory approval for children years after the drug is available in adults, encouraging off-label use of the drug in children and hindering attempts to obtain quality pediatric data in controlled trials. Extrapolating adult efficacy data to pediatrics can reduce the time between approval in adults and that in children. To extrapolate efficacy from adults to children, several assumptions must be supported, such as (1) a similar disease progression and response to interventions in adults and children, and (2) similar exposure response in adults and children. The Ped...
Source: Paediatric Drugs - April 3, 2018 Category: Pediatrics Authors: Arzimanoglou A, D'Cruz O, Nordli D, Shinnar S, Holmes GL, Pediatric Epilepsy Academic Consortium for Extrapolation (PEACE) Tags: Paediatr Drugs Source Type: research

NIH gambles on recycled drugs
Nature 499, 7458 (2013). http://www.nature.com/doifinder/10.1038/499263a Author: Meredith Wadman Early success could bolster congressional support for agency’s translational science centre.
Source: Nature - July 17, 2013 Category: Research Authors: Meredith Wadman Tags: News Source Type: research