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March 31, 2014
13:41 EDTNVS, MRKNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
News For NVS;MRK From The Last 14 Days
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July 24, 2014
08:32 EDTMRKMerck initiates Phase 3 study of Letermovir
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05:41 EDTNVSNovartis announces FDA acceptance of Sandoz application for filgrastim
Sandoz, a Novartis Group company, announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
July 23, 2014
06:41 EDTNVSArray BioPharma shares attractive at current levels, says Piper Jaffray
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
July 21, 2014
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:21 EDTMRKGilead could be hurt by new HCV drugs, says Wells Fargo
Noting that data on a new Merck (MRK) HCV treatment is expected in November, Wells Fargo thinks Merck's HCV drug could be combined with Gilead's (GILD) Sovaldi to shorten the duration of treatment to four weeks. Other companies could take similar actions, and Gilead's per patient revenues would be significantly reduced if this occurs, the firm warned. However, it continues to have an upbeat outlook on Gilead heading into what it sees as a strong quarter and is still upbeat on the company's long-term HCV opportunity. It keeps an Outperform rating on Gilead.
07:11 EDTNVSInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
06:43 EDTMRKGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 17, 2014
08:34 EDTNVSVanda requests award of $539M in proceedings with Novartis
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05:32 EDTNVSNovartis reconfirms FY14 revenue guidance up at low to mid single digit rate
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
July 16, 2014
06:26 EDTMRKBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTMRKPerrigo retreats after analyst sees limited potential buyers
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08:11 EDTMRKMerck looks to revive livestock drug Zilmax, WSJ says
Merck has been preparing to conduct a large-scale study this summer to evaluate the safety of its Zilmax feed additive, which the company pulled from the U.S. market last year over concerns in the beef industry that the drug made it difficult for some animals to walk, reported The Wall Street Journal. Reference Link
07:35 EDTMRKPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
05:44 EDTNVSNovartis to license Google 'smart lens' technology
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
05:35 EDTNVSNovartis collaborates with Banner Alzheimer's Institute on study
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
July 14, 2014
07:23 EDTNVSAlzheimer's Association to hold a conference
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July 10, 2014
16:12 EDTMRKMedivation names Dawn Svoronos as Chief Commercial Officer
Medivation (MDVN) announced Dawn Svoronos has been appointed as its chief commercial officer, reporting to David Hung, M.D., founder, CEO and president of Medivation. Svoronos currently is a member of Medivation's Board of Directors and is a former president of Europe and Canada for Merck & Co. (MRK), where she oversaw commercial operations in approximately 30 EU and EU accession countries. Svoronos will lead Medivation's commercial organization on an interim basis and will participate in the company's search for a permanent chief commercial officer. Cheryl Cohen, Medivation's former chief commercial officer, has left the company to pursue other opportunities.
15:43 EDTNVSNovartis siponimod designated as orphan treatment of dermatomyositis
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