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Stock Market & Financial Investment News

News For MYL;MRK From The Last 14 Days
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January 26, 2015
11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
08:31 EDTMRKMerck says CHMP issues positive opinion for Sivextro
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO for the treatment of acute bacterial skin and skin structure infections in adults. Merck acquired SIVEXTRO as a part of its purchase, through a subsidiary, of Cubist Pharmaceuticals, Inc. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. SIVEXTRO is a once-daily oxazolidinone antibiotic developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria.
January 23, 2015
06:39 EDTMRKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 21, 2015
10:16 EDTMRKLeerink 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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14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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07:23 EDTMRKMerck funding testing of lower dosages of Zilmax, Reuters reports
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January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
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.

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