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News Breaks
April 25, 2014
11:02 EDTMRK, SNYEMA 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."
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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
06:39 EDTMRKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTMRK, SNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
08:02 EDTMRKMerck completes tender offer to acquire Cubist
Merck (MRK) announced the successful completion of the tender offer for all of the outstanding shares of common stock of Cubist Pharmaceuticals (CBST) at a purchase price of $102.00 per share. As of the tender offer expiration yesterday, 58,039,667 shares of common stock of Cubist were validly tendered and not properly withdrawn from the tender offer, representing approximately 75.7% of the outstanding common stock of Cubist on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares. Following consummation of the tender offer, Merck expects to complete the acquisition of Cubist later today through a merger of Merckís wholly owned subsidiary with and into Cubist without stockholder approval. Upon completion of the merger, all outstanding shares of common stock of Cubist, other than shares held by Cubist in treasury or shares held by Cubistís stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $102.00 offer price per share without interest, less any applicable withholding taxes. In addition, upon completion of the merger, Cubist will become a wholly owned subsidiary of Merck and the common stock of Cubist will cease to be traded on the NASDAQ Stock Market.
January 20, 2015
17:18 EDTMRKDana Holding to replace Cubist in S&P 400 as of 1/22 close
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07:23 EDTMRKMerck funding testing of lower dosages of Zilmax, Reuters reports
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January 15, 2015
11:20 EDTMRKGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTMRKAmerican Society of Clinical Oncology to hold a symposium
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January 14, 2015
08:34 EDTMRKMerck and Practice Fusion's health vaccine initiative shows positive results
Merck and Practice Fusion announced the results of a recent collaboration designed to improve public health outcomes through a Population Health Management program for adult vaccines. Launched in April, the program contributed to a statistically significant relative increase in recorded vaccinations among eligible patients on Practice Fusion's EHR platform. During the four-month test period, Practice Fusion observed a 73% relative increase in recorded vaccinations in test versus control patients.
January 13, 2015
09:44 EDTMRKMerck makes $50M equity investment in Moderna under collaboration
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08:08 EDTMRKEli Lilly, Merck enter collaborationa greement to evaluate Keytruda, compounds
Merck (MRK) and Eli Lilly and Company (LLY) announced an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA, Merckís anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials: Merck will conduct a Phase 2 study examining the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer. This study is currently enrolling. Lilly will conduct a multiple-arm Phase 1/2 study examining the combination of ramucirumab with pembrolizumab in multiple tumors. This study is anticipated to begin in 2015. Lilly will conduct a Phase 1/2 study examining the combination of necitumumab with pembrolizumab in NSCLC. This study is anticipated to begin in 2015. The agreement is between Lilly and Merck, through a subsidiary. Additional details of the collaboration were not disclosed.
January 12, 2015
08:37 EDTMRK, SNYShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:21 EDTMRKEBD Group to hold a conference
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07:07 EDTMRKMerck sees NDA submission for Hepatitis C combination regimen in 1H15
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07:05 EDTMRKMerck says targeted cost savings on track to be realized by end 2015
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07:04 EDTMRKMerck sees NDA submission for Hepatitis C combination regimen in 1H15
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07:03 EDTMRKMerck says targeted cost savings on track to be realized by end 2015
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06:53 EDTMRKMerck to speed up plans for drug submission, WSJ says
Merck is speeding up its plans to submit new drugs for lung cancer and hepatitis C for regulatory approval, reports the Wall Street Journal. The company will file an application with the FDA around the mid-2015 to expand the use of Keytruda, the Journal adds. Reference Link
06:22 EDTMRKWHO approves 2 ebola vaccines to enter West Africa trials, Financial Times says
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