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News Breaks
December 14, 2012
08:07 EDTMRK, ARIAEMA says Merck withdraws application for Jenzyl
The European Medicines Agency said on November 27 Merck Sharp & Dohme (MRK) officially notified the Committee for Medicinal Products for Human Use, or CHMP, that it wishes to withdraw its application for a marketing authorization for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy. Jenzyl is the trade name for ridaforolimus, which is being co-developed by Merck and ARIAD Pharmaceuticals (ARIA). Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma, a type of cancer that affects the soft, supporting tissues of the body, or bone sarcoma that have spread to other parts of the body. The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions. The company had not yet responded to the last round of questions at the time of the withdrawal. Based on the review of the data and the company’s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy, the CHMP said.
News For ARIA;MRK From The Last 14 Days
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January 26, 2015
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 22, 2015
07:38 EDTARIAARIAD appoints DesRosier as Chief Legal and Administrative Officer
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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 Merck’s 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 Cubist’s 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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07:36 EDTARIAARIAD says EC endorses final opinion adopted by CHMP on Iclusig
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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.
07:20 EDTARIAARIAD sees product revenues reaching over $400M in 2018
For 2014, sees product and license revenue at $100M, R&D expenses $120M. For 2015, plans to accelerate Iclusig sales in U.S. and Europe, initiate key Iclusig trials, secure broad partnership for brigatinib, file for Iclusig approval in Japan with Otsuka, file IND for new development candidate AP32788. Comments from slides that will be presented at the JP Morgan Healthcare Conference.
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, Merck’s 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.
07:40 EDTARIAARIAD reports net sales of Iclusig of approx. $55M for year ended Dec. 31
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07:39 EDTARIAARIAD announces key strategic objectives for 2015
ARIAD Pharmaceuticals announced its key strategic objectives for 2015, details of which will be presented at the 33rd Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San Francisco, California. These objectives are focused on expanded commercial, research and development, and new business development initiatives that together are expected to lead ARIAD to sustained profitability beginning in 2018 without the need for additional equity capital to fund its operations. ARIAD management will provide detail on its corporate strategy for the next several years. This new focus includes: Expanding the global commercial opportunity for Iclusig through a Japan/Asia partnership with Otsuka Pharmaceutical Co., Ltd., and additional regional distributorships, Leveraging its existing commercial infrastructure and investment, particularly in Europe, Securing a broad co-development and co-commercialization partnership for brigatinib, or AP26113, that will accelerate the study of brigatinib in earlier lines of treatment, Investing in three randomized clinical trials to evaluate Iclusig in earlier lines of treatment and potentially to expand its addressable market, Advancing its new development candidate, AP32788, into the clinic, and Achieving sustained profitability in 2018 by reaching global product revenue of more than $400M. Three key Iclusig clinical trials will begin in 2015 including a randomized, Phase 3 trial in patients with chronic-phase CML who have experienced failure after imatinib therapy. This second-line, global trial will evaluate two doses of Iclusig vs. the standard dose of nilotinib. The primary endpoint of the trial will be major molecular response by 12 months. The trial is expected to open to patient enrollment in the second half of 2015 and will be integral to potentially expanding Iclusig into earlier lines of treatment. We expect that approximately 500 patients will be enrolled in this trial. ARIAD says "In a major strategic shift for ARIAD, we expect to secure a broad partnership in 2015 to co-develop and co-commercialize brigatinib. In doing so, we will continue to leverage our existing infrastructure and capabilities, allowing us to accelerate the start of a randomized, first-line trial of brigatinib vs. crizotinib. A partnership will also provide for the exploration of new combination therapies in lung cancer that include brigatinib potentially with other approved and unapproved medicines." The company comments, "We expect to achieve profitability in 2018 through revenue growth and strategic partnerships over the next three years. This includes Iclusig revenue growth in the U.S. and in Europe, as well as Iclusig revenue from Japan and new geographies. We also anticipate increased cash flow from brigatinib revenue and partnership payments during this time period. We expect approval of Iclusig in Canada and Israel in 2015 and in Japan in 2016."

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