Merck & Co Inc (MRK) Key Developments | Reuters.com
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Merck & Co Inc (MRK)

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Latest Key Developments (Source: Significant Developments)

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

Merck & Co Inc Receives Positive CHMP Opinion for Investigational Antibiotic ZERBAXA
Monday, 27 Jul 2015 08:30am EDT 

Merck & Co Inc:Says Receives positive chmp opinion for investigational antibiotic Zerbaxa(TM) (ceftolozane and tazobactam).Says chmp positive opinion will be reviewed by the European commission.  Full Article

Merck announces fourth-quarter 2015 dividend
Wednesday, 22 Jul 2015 01:28pm EDT 

Merck:Declared a quarterly dividend of $0.45 per share of common stock for fourth quarter of 2015.Payment will be made on Oct. 7, 2015, to shareholders of record at the close of business on Sept. 15, 2015.  Full Article

Merck announces phase 3 study of single-dose EMEND
Monday, 29 Jun 2015 08:30am EDT 

Merck:Says results from a Phase 3 study investigating safety and efficacy of single-dose EMEND (fosaprepitant dimeglumine) for Injection, Merck's substance P/neurokinin (NK-1) receptor antagonist, in combination with other anti-vomiting medicines.Says for prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC).Says plans to submit these recent data to the food and drug administration in the second half of 2015.  Full Article

Merck & Co Inc Cardiovascular safety trial of Januvia (Sitagliptin), met primary endpoint in patients with type 2 diabetes
Wednesday, 10 Jun 2015 07:00am EDT 

Merck & Co Inc:Cardiovascular safety trial of Januvia (Sitagliptin), met primary endpoint in patients with type 2 diabetes.Says treatment with sitagliptin did not increase the risk of major adverse cardiovascular events in the primary composite endpoint.Says there was no increase in hospitalization for heart failure, and rates of all-cause mortality were similar in both treatment groups.  Full Article

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Roche CEO 'sleeps better' as risk to drugmaker's growth recedes

LONDON Roche is increasingly confident it will continue to lift sales and profit even as cut-rate copies of the Swiss drugmaker's older cancer medicines start to grab business next year, its chief executive said on Wednesday.