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Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes
2016-06-11 17:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. & NEW YORK Ongoing CV Outcomes Trial of Ertugliflozin Expanded to Test for Superiority in CV Risk Reduction KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints. The study results showed statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested (5 mg and 15 mg daily). Language: English Contact: Merck Media Contacts:Doris Li, 908-246-5701orKristen Drake, 908-334-4688orMerck Investor Contact:Justin Holko, 908-740-1879orPfizer Media Contact:Steve Danehy, 212-733-1538orPfizer Investor Contact:Ryan Crowe, 212-733-8160 Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: PFE Exchange: NYSE read more
Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
2016-06-09 23:04:32| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. Language: English read more
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H3 Biomedicine Receives FDA Acceptance For Investigational New Drug Application
2016-06-01 06:06:14| drugdiscoveryonline Home Page
H3 Biomedicine Inc., a biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of the Eisai Group, announced recently that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800
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Merck Announces FDA Accepts Samsung Bioepis Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
2016-05-24 01:50:08| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck KENILWORTH, N.J. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. Language: English read more
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Merck to Present Phase 3 Data on Investigational Medicines Ertugliflozin and MK-1293 at the 76th Scientific Sessions of the American Diabetes Association
2016-05-12 14:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Additional Analyses from the TECOS Cardiovascular Safety Trial of JANUVIA (sitagliptin) Also to Be Presented KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that researchers will present data from clinical trials of its investigational diabetes pipeline, JANUVIA (sitagliptin), and new real-world research in more than 20 scientific data presentations at the 76th Scientific Sessions of the American Diabetes Association (ADA) being held in New Orleans, June 10-14, 2016. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Kristen Drake, 908-236-4223orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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