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Merck & Co Inc (MRK)

MRK on New York Consolidated

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28 Apr 2017
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Latest Key Developments (Source: Significant Developments)

PDL BioPharma announces settlement of Keytruda lawsuit with Merck
Monday, 24 Apr 2017 07:00am EDT 

April 24 (Reuters) - PDL BioPharma Inc ::PDL BioPharma announces settlement of Keytruda patent infringement lawsuit with Merck.PDL BioPharma Inc - under terms of agreement, Merck will pay company a one time, lump-sum payment of $19.5 million.PDL BioPharma Inc - company will grant Merck a fully paid-up, royalty free, non-exclusive license to certain of company's Queen et al.PDL BioPharma Inc - in addition, parties agreed to dismiss all claims in relevant legal proceedings.PDL BioPharma Inc - as a result of settlement, expect to recognize $19.5 million in license revenue for q2 ending june 30, 2017.  Full Article

FDA approves Renflexis, biosimilar to Remicade
Friday, 21 Apr 2017 03:54pm EDT 

April 21 (Reuters) - FDA::FDA approves Renflexis, biosimilar to Remicade.  Full Article

Merck reports results from real-world observational study in U.S. Veterans Affairs System evaluating use of ZEPATIER
Friday, 21 Apr 2017 10:00am EDT 

April 21 (Reuters) - Merck & Co Inc : :Real-World observational study in the U.S. Veterans Affairs System evaluating use of Merck’S ZEPATIER® (Elbasvir and Grazoprevir) shows high sustained virologic response rates in patients with chronic Hepatitis C.For evaluable population, 95.6 percent of veterans treated with ZEPATIER achieved primary outcome of sustained virologic response.  Full Article

Atara bio announces collaboration with Merck
Friday, 21 Apr 2017 08:00am EDT 

April 21 (Reuters) - Atara Biotherapeutics Inc ::Atara Bio announces collaboration with Merck to evaluate keytruda (pembrolizumab) in combination with ATA129 in nasopharyngeal carcinoma (NPC).Atara Biotherapeutics-phase 1/2 trial to evaluate safety, pharmacokinetics, pharmacodynamics, preliminary efficacy of combination; planned for initiation in 2018.Collaboration agreement is between Atara Biotherapeutics, Inc. And Merck Sharp & Dohme B.V.Under agreement, trial will be sponsored by Atara Bio.Additional details of collaboration were not disclosed.  Full Article

KYORIN Holdings unit gets license from Merck for drug KRP-114V
Tuesday, 11 Apr 2017 01:45am EDT 

KYORIN Holdings Inc <4569.T> :Says its pharma unit receives license from US firm Merck & Co Inc for drug KRP-114V, a treatment for overactive bladder, owning exclusive rights to develop and commercialize in Asian area.  Full Article

Merck receives complete response letter from the FDA for Tecos study with sitagliptin
Friday, 7 Apr 2017 07:30am EDT 

Merck & Co Inc : Merck receives complete response letter from the U.S. FDA for Tecos study with Sitagliptin . Merck & Co Inc- Merck is reviewing letter and will discuss next steps with FDA .Merck & Co- with the applications, co seeking to include data from Tecos in prescribing information of Sitagliptin-containing medicines.  Full Article

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

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