Key Developments: Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Merck & Co Inc announces FDA approves RAGWITEK Sublingual tablet as immunotherapy to treat short ragweed Pollen-Induced Allergic Rhinitis with or without conjunctivitis in adults
Thursday, 17 Apr 2014 06:22pm EDT 

Merck & Co Inc:U.S. Food and Drug Administration (FDA) has approved RAGWITEK (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use (12 Amb a 1-U).RAGWITEK is allergen extract indicated as immunotherapy for treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen.RAGWITEK is approved for use in adults 18 through 65 years of age. RAGWITEK is not indicated for the immediate relief of allergic symptoms.Prescribing information for RAGWITEK includes a boxed warning regarding severe allergic reactions.  Full Article

Sanofi and Merck vaccines JV initiates legal proceedings against Spain's Ministry of Health-IHS Global Insight Daily Analysis
Wednesday, 16 Apr 2014 08:00pm EDT 

Sanofi SA:Sanofi and Merck & Co Inc's vaccines joint venture Sanofi Pasteur MSD initiates legal proceedings against Spain's Ministry of Health (MoH) for blocking the sale of the chickenpox vaccine Varivax in pharmacies - IHS Global Insight Daily Analysis.Initiative follows on from claims by Spanish Association of Pharmacists (FEFE) that MoH's decision to withhold chickenpox vaccines from pharmacies is arbitrary and has no legal basis.MoH claims that chickenpox is being over-vaccinated in Spain.  Full Article

Merck & Co Inc announces FDA approves Grastek sublingual tablet for treatment of grass Pollen-Induced Allergic Rhinitis
Monday, 14 Apr 2014 05:59pm EDT 

Merck & Co Inc:U.S. Food and Drug Administration (FDA) has approved GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)].GRASTEK is allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.GRASTEK is approved for use in persons 5 through 65 years of age.GRASTEK is not indicated for immediate relief of allergic symptoms.Prescribing information for GRASTEK includes boxed warning regarding severe allergic reactions.GRASTEK is contraindicated in patients with severe, unstable or uncontrolled asthma, a history of any severe systemic allergic reaction, a history of any severe local reaction after taking any sublingual allergen immunotherapy, a history of eosinophilic esophagitis.Says or hypersensitivity to any of inactive ingredients contained in product.Symptoms of grass pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during grass pollen season.  Full Article

Merck and Sanofi Pasteur Gardasil approved in EU-PR Newswire Europe
Sunday, 6 Apr 2014 08:00pm EDT 

Sanofi SA:European Commission grants marketing authorization for quadrivalent Human Papillomavirus (HPV) vaccine Gardasil developed by Sanofi Pasteur and Merck & Co Inc joint venture Sanofi Pasteur MSD - PR Newswire Europe.Authorization is granted for 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.Approval of this new schedule for Gardasil follows positive opinion from European Medicines Agency (EMA) granted in February, based on Canadian study performed by Dobson et al.Study demonstrated that 2-dose 0, 6 month schedule in 9-13 year old girls elicited immune response comparable/non-inferior to that of 3 doses in 16-26 year old women, population where quadrivalent vaccine efficacy has been shown.Results were sustained at 36 months of follow-up.  Full Article

Merck & Co Inc announces appointment of Robert M. Davis as Chief Financial Officer
Thursday, 27 Mar 2014 07:20am EDT 

Merck & Co Inc:Appointment of Robert M. Davis as executive vice president and chief financial officer effective April 23.Davis succeed Peter N. Kellogg.Kellogg will work closely with Davis to ensure aseamless transition and will leave Merck on May 16.  Full Article

Merck & Co Inc and Endocyte announce European CHMP Positive Opinions for VYNFINIT and Companion Imaging Agents FOLCEPRI and NEOCEPRI in Patients with Platinum-Resistant
Friday, 21 Mar 2014 08:05am EDT 

Merck & Co Inc:Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued positive opinions for Conditional Marketing Authorisations of VYNFINIT and companion imaging components, imaging agent FOLCEPRI and NEOCEPRI.For treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD).Positive CHMP opinions bring Merck and Endocyte one step closer to providing a personalized approach to address a significant unmet medical need in platinum-resistant ovarian cancer.  Full Article

Alk Abello's partner Merck presents data on investigational house dust mite sublingual allergy immunotherapy tablet
Tuesday, 4 Mar 2014 05:30pm EST 

Alk Abello A/S:Says ALK's partner in North America, Merck & Co Inc, known as MSD outside the USA and Canada, presents new data from a Phase IIb trial with its investigational sublingual house dust mite allergy immunotherapy tablet.Says the data is presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, USA.Says the trial results showed that both doses of active treatment significantly reduced the average total nasal symptom score compared to placebo in adults with house dust mite-induced allergic rhinitis.  Full Article

Merck & Co Inc announces second-quarter 2014 dividend
Tuesday, 25 Feb 2014 12:31pm EST 

Merck & Co Inc:Declared a quarterly dividend of $0.44 per share.Payment will be made on April 7, to stockholders of record on March 17.  Full Article

FDA accepts for review Merck & Co Inc'S biologics license application for V503, investigational 9-valent human papillomavirus vaccine
Thursday, 20 Feb 2014 08:30am EST 

Merck & Co Inc:Says Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration.  Full Article

Merck & Co Inc to settle NuvaRing lawsuits for $100 mln-Reuters
Thursday, 6 Feb 2014 06:10pm EST 

Merck & Co Inc:According to Bloomberg Merck & Co Inc has agreed to pay $100 million to settle hundreds of lawsuits accusing the U.S. drugmaker of downplaying serious health risks associated with its NuvaRing contraceptive device-Reuters.The agreement, which would settle cases in federal and state courts, will be announced on Friday and pay about $58,000 per complaint.Merck is facing more than 1,700 lawsuits.  Full Article

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Merck's ragweed pollen allergy drug gets U.S. approval

- The U.S. Food and Drug Administration has approved Merck & Co's pollen allergy drug Ragwitek.

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