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News Breaks
March 28, 2014
06:57 EDTAZN, RHHBY, SNY, BMY, NVS, MRK, LLY, PFE, JNJ, GSKBaxter spin-off to encourage others to follow suit, Reuters columnist says
After Baxter said that it would separate its biotech and medical products units, a Reuters columnist says that Baxter's shareholders will benefit from the move. As a result, other large drug companies will be more likely to split their companies, the columnist contended. 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). Reference Link
News For AZN;JNJ;PFE;LLY;MRK;NVS;BMY;SNY;RHHBY;GSK From The Last 14 Days
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September 5, 2014
08:41 EDTJNJJohnson & Johnson initiated with an Outperform at BMO Capital
Target $118.
08:39 EDTMRKMerck Keytruda sales to reach $5B in 2018, says BMO Capital
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September 4, 2014
17:15 EDTAZNAstraZeneca granted orphan status for EFGR non-small cell lung cancer treatment
The FDA posted on its website that AstraZeneca has been granted orphan status for its treatment of epidermal growth factor receptor, or EFGR, mutation-positive non-small cell lung cancer. Reference Link
16:05 EDTPFEPfizer granted orphan status for sickle cell disease drug
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15:16 EDTMRKMerck receives accelerated approval of Keytruda
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11:05 EDTJNJJ&J unit Janssen receives orphan status for whipworm treatment
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09:02 EDTMRKMerck's relebactam granted QIDP, fast track designations by FDA
Merck announced that the U.S. Food and Drug Administration has designated relebactam -- previously known as MK-7655 -- the companyís investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
08:11 EDTLLYEli Lilly's insulin peglispro for diabetes shows positive Phase III results
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08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).
07:23 EDTPFE, AZNAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
07:21 EDTMRKMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
05:23 EDTJNJJohnson & Johnson to fast-track development of Ebola combination vaccine regimen
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September 3, 2014
17:25 EDTMRKMerck management to meet with SunTrust
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16:20 EDTRHHBYOn The Fly: Closing Wrap
Stocks on Wall Street began the session in positive territory after Russian President Vladimir Putin said he had an outline for a cease-fire plan for eastern Ukraine and was closing in an agreement. The averages hit their highs shortly after the open and the Nasdaq was the first index to cross into negative territory as it was weighed down by Apple's (AAPL) decline. The market moved in a narrow range as investors anticipated the Fedís Beige Book report, scheduled for release mid-afternoon. The report was fairly benign and the market limped into the close, with volume remaining light. ECONOMIC EVENTS: U.S. factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book stated that the pace of growth did not change significantly in any of the central bank's 12 regions during a six week period ended in August compared with the previous six week period. COMPANY NEWS: Shares of Apple retreated $4.36, or 4.22%, to $98.94 after research firm Pacific Crest advised investors to take some profits in the stock. Analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which surged $4.81, or 44.05%, to $15.73 after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which jumped $3.94, or 9.16%, to $46.97 ahead of its second quarter earnings report, which is due tomorrow morning. Among the noteworthy losers was Repros Therapeutics (RPRX), which fell $4.11, or 18.55%, to $18.05 after FDA briefing documents ahead of a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower after its earnings report was apparel company Vince Holding (VNCE), which fell $4.47, or 11.54%, to $34.27. Analysts at Piper Jaffray attributed the post-earnings weakness to investor concerns over heightened inventory levels, but the firm said it still sees Vince as one of the best small cap growth names in its space and would be "aggressive buyers" on the weakness. INDEXES: The Dow edged up 10.72, or 0.06%, to 17,078.28, the Nasdaq fell 25.62, or 0.56%, to 4,572.56, and the S&P 500 slipped 1.56, or 0.08%, to 2,000.72.
12:49 EDTSNYSanofi reports Dengue vaccine candidate achieves its phase 3 primary endpoint
Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase 3 efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8% of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofiís phase 3 dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.
12:33 EDTRHHBYOn The Fly: Midday Wrap
Stocks on Wall Street were higher to begin the day, as reports spurred optimism that a ceasefire agreement between Russia and the Ukraine may soon be reached. The move was short lived, as the averages turned mixed during the second hour of trading. Shares of Apple (AAPL) are weighing down the Nasdaq after an analyst recommended investors take some profits in the stock. ECONOMIC EVENTS: In the U.S., factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book is scheduled to be released at 2:00 pm ET. In Europe, the final reading of Eurozone services PMI was knocked down to 53.1 from a preliminary 53.5 reading, mirroring the lowering of the Eurozone manufacturing PMI reading yesterday. COMPANY NEWS: Shares of Apple retreated 4% after research firm Pacific Crest advised investors to take some profits in the stock. Pacific Crest analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event... Carmakers reported on August vehicle sales in the U.S., with Chrysler (FIATY) reporting a 20% increase, Ford stating that sales rose slightly compared to the prior year and General Motors (GM) posting a 1.2% decline in sales. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which jumped 46% after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which gained nearly 10% after Morgan Stanley wrote that the stock could rise "towards $100" if the company maintains its current market, gross margins and earnings position. Mobileye is scheduled to report on its second quarter results tomorrow morning, which will be its first quarterly report since its August IPO. Among the noteworthy losers was Repros Therapeutics (RPRX), which dropped 15% after newly posted FDA briefing documents regarding a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower following its earnings report was apparel company Vince Holding (VNCE), which fell 11%. INDEXES: Near midday, the Dow was up 33.71, or 0.2%, to 17,101.27, the Nasdaq was down 23.24, or 0.51%, to 4,574.95, and the S&P 500 was down 0.64, or 0.03%, to 2,001.64.
11:30 EDTPFEPfizer has conference call hosted by Bernstein
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06:48 EDTRHHBYInfinity Pharmaceuticals partners with Roche for blood cancer clinical studies
Infinity Pharmaceuticals (INFI) has entered into a master clinical supply agreement with Roche (RHHBY) under which Roche will supply Gazyva to Infinity for use in planned clinical studies to evaluate the combination of Gazyva and duvelisib, Infinityís oral inhibitor of phosphoinositide-3-kinase -delta and PI3K-gamma, in patients with hematologic malignancies, or blood cancers. The companies have also entered into a material transfer agreement under which Infinity is supplying Roche with duvelisib for use in Rocheís preclinical and translational research to evaluate the combination of duvelisib and Gazyva.
05:44 EDTAZNTeva announces positive judgement in patent case against AstraZeneca
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05:43 EDTNVSNovartis Gilenya data redefining MS treatment goals
Novartis announced that new analyses to be presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, MA from September 10-13, will add to the growing evidence confirming the importance of redefining treatment goals in multiple sclerosis, or MS. The goal of MS treatment is to have 'no evidence of disease activity' or 'NEDA', which is currently defined as no evidence of relapses, MRI lesions and disability progression. New data to be presented will reinforce the clinical relevance of brain shrinkage and highlight the benefit of including it as a fourth key measure of MS in the definition of NEDA. In addition, other analyses will show that patients treated with Gilenya were more likely to achieve NEDA based on assessment of these four key measures, including MS-related brain shrinkage, than those on placebo. New Gilenya analyses will show how brain shrinkage is associated with future long-term disability progression in patients with MS and that patients with relapsing MS treated with Gilenya had lower rates of brain shrinkage that importantly were sustained over time. The findings will also provide further evidence of the high efficacy of Gilenya on MS disease activity across four key measures.
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