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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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29 Mar 2017
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Latest Key Developments (Source: Significant Developments)

European Medicines Agency's CHMP recommends approval of Merck's keytruda
Friday, 24 Mar 2017 08:13am EDT 

Merck & Co Inc : European Medicines Agency's CHMP recommends approval of Merck's keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical hodgkin lymphoma .Merck & Co Inc- decision on approval is expected in Q2 of 2017.  Full Article

U.S. appeals court revives claims against Merck over Fosamax
Wednesday, 22 Mar 2017 08:33am EDT 

U.S. Appeals Court Revives Hundreds Of Claims Alleging Merck & Co : Failed to adequately warn about the risks of fosamax -- court ruling . Decision issued by 3rd u.s. Circuit court of appeals in Philadelphia . Appeals court says lower court judge erred in dismissing claims on the ground they were preempted by federal law . Appeals court says plaintiffs can pursue claim that merck should have warned about risk of thigh bone fractures associated with fosamax . Further company coverage: [MRK.N].  Full Article

Merck says FDA approves keytruda for treatment of patients with refractory classical hodgkin lymphoma
Tuesday, 14 Mar 2017 05:05pm EDT 

Merck & Co Inc : FDA approves Merck's Keytruda® (pembrolizumab) for adult and pediatric patients with classical hodgkin lymphoma (chl) refractory to treatment, or who have relapsed after three or more prior lines of therapy .Merck & Co - FDA has approved keytruda for treatment of adult and pediatric patients with refractory classical hodgkin lymphoma.  Full Article

Merck provides update on supplemental biologics license application (sbla) for KEYTRUDA® (pembrolizumab)
Tuesday, 14 Mar 2017 04:43pm EDT 

Merck & Co Inc : Merck provides update on supplemental biologics license application (sbla) for keytruda® (pembrolizumab) in previously treated advanced microsatellite instability-high cancer . Merck & co inc - new fda target action date is june 9, 2017 .Merck & co-submission of additional data is considered major amendment to sbla under pdufa, thus extending target action date by three months.  Full Article

Merck and pfizer announce U.S. Fda and EMA filing acceptances
Monday, 6 Mar 2017 08:00am EST 

Merck & Co Inc : Merck and Pfizer announce U.S. Fda and EMA filing acceptances of 3 marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes .Says prescription drug user fee act (PDUFA) action date from the FDA is in December 2017 for the three NDAS.  Full Article

Glenmark Pharmaceuticals and Evestra announce partnership agreement for generic NuvaRing
Wednesday, 1 Mar 2017 01:58pm EST 

Glenmark Pharmaceuticals Inc USA: Glenmark Pharmaceuticals And Evestra, Inc. announce partnership agreement for generic NuvaRing . Glenmark Pharmaceuticals USA and Evestra, expect to file an Abbreviated New Drug Application in fiscal 2019 . Evestra will develop this product exclusively for Glenmark for U.S. Market .Has secured exclusive marketing and distribution rights for product, for U.S. Market.  Full Article

Merck sets quarterly dividend of $0.47/share
Tuesday, 28 Feb 2017 01:47pm EST 

Merck :Sets quarterly dividend of $0.47 per share.  Full Article

In first phase 3 trial Merck's virus vaccine (V2120 reduced the incidence of confirmed herpes zoster cases
Friday, 24 Feb 2017 04:00pm EST 

Merck & Co Inc : In first phase 3 trial, Merck's investigational inactivated varicella zoster virus vaccine (V212) reduced the incidence of confirmed herpes zoster cases by an estimated 64 percent in immunocompromised subjects . Merck & Co Inc - in trial, V212 met its primary endpoint . Merck & Co Inc - secondary endpoint findings from study showed that V212 reduced incidence of moderate-to-severe hz pain by an estimated 69.5 percent . Merck & Co Inc - in addition, v212 showed reduction of other hz complications by an estimated 73.5 percent . Merck & Co - in trial, V212 demonstrated an estimated 83.7 percent reduction of incidence of post-herpetic neuralgia beyond 90 days after onset of hz .Merck- look forward to exploring data further, reviewing results of additional phase 3 study that is underway in immunocompromised patients with malignancies.  Full Article

Merck to record $2.9 bln impairment charge related to uprifosbuvir program - SEC filing
Thursday, 23 Feb 2017 05:53pm EST 

Merck & Co Inc : On Feb 17, determined that it will record intangible asset impairment charge related to research program for MK-3682, uprifosbuvir - SEC filing . Company's previously reported Q4 and full year non-GAAP EPS remain unchanged - SEC filing . Continues to evaluate options with respect to uprifosbuvir clinical development program . Will monitor remaining $240 million intangible asset for further impairment . "Will monitor remaining $240 million intangible asset for further impairment" . Previously reported Q4 2016 GAAP diluted earnings per share (EPS) were reduced from $0.42 to a loss of $0.22 . $240 million fair value is to be recognized as a pre-tax impairment charge of $2.9 billion, which is to be reflected in the Co’s 2016 results .Full-year 2016 GAAP EPS were reduced from $2.04 to $1.41.  Full Article

Biothera Pharmaceuticals initiates patient dosing in phase 2 trial investigating Imprime PGG, Merck's Keytruda
Thursday, 23 Feb 2017 09:00am EST 

Merck & Co Inc : Biothera Pharmaceuticals initiates patient dosing in phase 2 trial investigating imprime pgg and merck’s keytruda® (pembrolizumab) .Biothera pharmaceuticals initiates patient dosing in phase 2 trial investigating imprime pgg and merck's keytruda® (pembrolizumab).  Full Article

More From Around the Web

BRIEF-European Medicines Agency's CHMP recommends approval of Merck's keytruda

* European Medicines Agency's CHMP recommends approval of Merck's keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical hodgkin lymphoma