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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

22 Jul 2016
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Latest Key Developments (Source: Significant Developments)

MacroGenics Inc and Merck to collaborate on Immuno-Oncology study
Thursday, 22 Oct 2015 07:30am EDT 

MacroGenics Inc and Merck:Says collaboration to evaluate the combination of MacroGenics' anti-HER2 product candidate, margetuximab, with Merck's anti-PD-1 therapy, KEYTRUDA, in a Phase 1b/2 clinical trial in patients with advanced gastric cancer.Says agreement is between MacroGenics and Merck, through a subsidiary.Additional details were not disclosed.  Full Article

OBI Pharma, Inc. enters exclusive agreement with Merck for rights to DIFICID (fidaxomicin) in Taiwan
Sunday, 4 Oct 2015 05:58am EDT 

OBI Pharma, Inc:Says an agreement with MSD, known as Merck in the United States and Canada, through a subsidiary transferring exclusive rights to develop and commercialize Dificid (fidaxomicin) in Taiwan to MSD.Says this agreement will enable the launch of Dificid in Taiwan utilizing MSD's extensive market expertise and knowledge, with the potential to benefit patients in Taiwan suffering from Clostridium Difficile- Associated Diarrhea (CDAD).Under the terms of the agreement, OBI Pharma will receive an initial up-front payment of US$3.0 million from MSD and is eligible to receive royalties and payments associated with the completion of certain undisclosed milestones.MSD will be responsible for all future costs associated with commercialization, development, and manufacturing of DIFICID in Taiwan.  Full Article

Merck & Co Inc says FDA approves KEYTRUDA for treatment of patients with metastatic non-small cell lung cancer
Friday, 2 Oct 2015 02:49pm EDT 

Merck & Co Inc:FDA approves KEYTRUDA for treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy.  Full Article

Merck & Co Inc and DNAtrix announce phase 2 immuno-oncology collaboration in patients with aggressive form of brain cancer
Thursday, 1 Oct 2015 08:00am EDT 

Merck & Co Inc and DNAtrix:Enters into oncology clinical study collaboration to evaluate the efficacy and safety of DNX-2401, DNAtrix's oncolytic immunotherapy, in combination with KEYTRUDA(reg) (pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 2, multi-centered study of patients with recurrent glioblastoma.  Full Article

Merck & Co Inc's MARIZEV (Omarigliptin), Merck's Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan
Monday, 28 Sep 2015 07:30am EDT 

Merck & Co Inc:Announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved MARIZEV((reg))(omarigliptin) 25 mg and 12.5 mg tablets, an oral, once-weekly DPP-4 inhibitor indicated for the treatment of adults with type 2 diabetes. Japan is the first country to have approved omarigliptin.  Full Article

Merck & Co Inc says results of Phase 2 Study of Merck's Investigational Beta-Lactamase Inhibitor Relebactam Presented at ICAAC/ICC 2015
Friday, 18 Sep 2015 03:00pm EDT 

Merck & Co Inc:Says Phase 2 study of relebactam, company's investigational beta-lactamase inhibitor for treatment, in combination with imipenem/cilastatin of complicated intra-abdominal infections, met its primary endpoint that Merck is now initiating pivotal Phase 3 studies.Says in Phase 2 study, relebactam in combination with imipenem/cilastatin demonstrated noninferiority in percentage of microbiologically evaluable patients with favorable clinical response at end of intravenous therapy compared to imipenem/cilastatin alone.Says planning to initiate two pivotal Phase 3 clinical studies of relebactam with imipenem/cilastatin given as a fixed-dose combination.  Full Article

Merck & Co Inc announces approval of Brenzys in Korea
Tuesday, 8 Sep 2015 08:30am EDT 

Merck & Co Inc:Samsung bioepis announces approval of Brenzys(TM) (etanercept), a biosimilar of enbrel, in Korea.Says Merck plans to launch brenzys in South Korea by the end of this year or early next year.Says additional regulatory filings for each of five biosimilar candidates are expected to occur in the 2015-2016 timeframe.  Full Article

Merck & Co Inc raises FY 2015 EPS outlook; raises low end of prior FY 2015 revenue guidance to a range in line with analysts' estimates
Tuesday, 28 Jul 2015 07:00am EDT 

Merck & Co Inc:Says that it has narrowed and raised its FY 2015 non-GAAP EPS range to be between $3.45 and $3.55, including a negative impact from foreign exchange.Lowered its FY 2015 GAAP EPS range to be between $1.52 and $1.71.Says change in GAAP EPS range reflects incorporation of foreign exchange losses related to Venezuela, as well as anticipated gain on previously announced sale of certain migraine clinical development programs.Now anticipates FY 2015 revenues to be between $38.6 billion and $39.8 billion, including a negative impact from foreign exchange and about $1 billion of net lost sales from acquisitions and divestitures.FY 2015 EPS of $3.45 and revenue of $39.7 billion - Thomson Reuters I/B/E/S.  Full Article

Merck buys cCam Biotherapeutics for $95 mln upfront payment in cash
Tuesday, 28 Jul 2015 06:45am EDT 

Merck:Says Enhances immuno-oncology portfolio with acquisition of ccam biotherapeutics.Says upfront payment of $95 million in cash.Says under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of ccam.Acquisition provides Merck with several early immunotherapy candidates including ccam biotherapeutics' lead pipeline candidate, cm-24.Says based on the transaction, ccam biotherapeutics, domiciled in Israel, will become a wholly owned subsidiary of Merck.Ccam shareholders of record eligible to receive up to $510 million associated with attainment of clinical development, regulatory milestones.Says based on transaction, ccam biotherapeutics wil continue to advance the development of cm-24 in its ongoing phase 1 clinical trial.  Full Article

Merck & Co Inc announces U.S. FDA acceptance of NDA for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection
Tuesday, 28 Jul 2015 06:30am EDT 

Merck & Co Inc:Announces U.S. food and drug administration acceptance of new drug application for grazoprevir/elbasvir, an investigational therapy for treatment of chronic hepatitis c genotypes 1, 4 and 6 infection.Says company granted FDA priority review with target action date of Jan. 28, 2016.  Full Article

BRIEF-Merck says EMA has accepted file for formulation of Isentress for review

* Says European Medicines Agency (EMA) has accepted file for investigational once-daily formulation of isentress for review