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News Breaks
April 25, 2014
11:02 EDTSNY, MRKEMA backs new indication for Sanofi's Gardasil, Merck's Silgard
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for Sanofi's (SNY) medicinal product Gardasil. The CHMP adopted a new indication of: "Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital wartscausally related to specific HPV types." The CHMP also adopted a positive opinion recommending a variation to the terms of the marketing authorization for Merck Sharp & Dohme's (MRK) Silgard. The CHMP adopted a new indication of: "Silgard is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital warts causally related to specific HPV types."
News For SNY;MRK From The Last 14 Days
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September 18, 2014
08:48 EDTMRKNeogen's dairy genomic program to be marketed by Merck
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September 17, 2014
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTMRKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
16:00 EDTMRKOptions Update; September 8, 2014
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14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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