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February 10, 2013
18:55 EDTLLY, SNY, NVONovo Nordisk receives FDA 'Complete Response Letter" for Tresiba and Ryzodeg
Novo Nordisk announced that on 8 February it received a Complete Response Letter from the US Food and Drug Administration, FDA, regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). A complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form. Reference Link
News For NVO;SNY;LLY From The Last 14 Days
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September 30, 2015
06:16 EDTLLYEli Lilly volatility at 52-week highs
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05:41 EDTLLYEli Lilly, Adocia initiate new Phase 1b study evaluating BioChaperone Lispro
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September 29, 2015
12:35 EDTSNYPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
09:27 EDTLLYOn The Fly: Pre-market Movers
HIGHER: Yahoo (YHOO), up 4.5% after the company's board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA)... Phoenix Companies (PNX), up 164% after Nassau Reinsurance agreed to acquire Phoenix for $37.50 per share in cash... McDonald's (MCD), up 1.4% after the stock was upgraded to Outperform at Credit Suisse... Johnson & Johnson (JNJ), up 1% following upgrade at Deutsche Bank. LOWER: Esperion (ESPR), down 29% after reporting that the FDA has encouraged the company to initiate a cardiovascular outcomes trial promptly since any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval... Solera (SLH), down 2% after IHS (IHS) said on its earnings call that it is not pursuing an acquisition of the company, as previouly indicated in media reports... Zosano (ZSAN), down 54% after the company announced that it would discontinue its ZP-PTH agreement with Eli Lilly (LLY).
08:43 EDTLLYZosano Pharma price target lowered to $11 from $20 at Roth Capital
Roth Capital cut its price target on Zosano (ZSAN) after the company announced that it would discontinue its ZP-PTH agreement with Eli Lilly (LLY) in order to focus on a one time per week program. The firm expects Zosano's shares to drop significantly today, but it continues to expect the company's other programs to generate positive data. It keeps a Buy rating on the shares.
08:07 EDTSNYSanofi announces FDA accepted filing of NDA for lixisenatide
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06:47 EDTLLYEli Lilly and Incyte's baricitinib Phase 3 study met primary objective
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05:16 EDTSNYSanofi announces NDA for Lixisenatide accepted for review by FDA
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September 28, 2015
19:11 EDTLLYOn The Fly: After Hours Movers
HIGHER: Yahoo (YHOO), up 3.3% after the board authorized Yahoo to continue to pursue the Aabaco spin-off plan... Cheniere Energy (LNG), up 0.67% after Carl Icahn raised his stake in the company to 11.43%... Republic Airways (RJET), up 7.4% after the company was upgraded to Buy from Hold at Deutsche Bank... Exelon (EXC) and Pepco (POM), higher by 1% and 2.4%, respectively, after the DC Mayor's office released a statement confirming discussions of a settlement agreement with the companies. LOWER AFTER EARNINGS: SYNNEX (SNX), down 2.7% after the company reported Q3 results, gave Q4 guidance, and raised its quarterly dividend. ALSO LOWER: Zosano (ZSAN), down 52.5% after it discontinued development of its Daily ZP-PTH treatment for severe osteoporosis and terminated a collaboration agreement with Eli Lilly (LLY)... OvaScience (OVAS), down 15.9% after the company announced it doesn't expect to meet its previous 2015 goal of 1,000 Augment treatment cycles.
09:35 EDTSNY, LLYEli Lilly and Sanofi reach settlement agreement in glargine litigation
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09:33 EDTSNY, LLYSanofi reaches patent settlement with Eli Lilly on Lantus
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08:04 EDTLLYEli Lilly announces study of Cyramza in combination met primary end
A Phase II study of Eli Lilly's CYRAMZA in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy. Bladder cancer accounts for the vast majority of all urothelial carcinoma. Final results of the Phase II trial were presented at the European Cancer Congress (ECC2015) in Vienna, Austria on September 27. Based on these findings, Lilly recently initiated a Phase III trial called RANGE, which has begun to enroll patients. The three-arm trial evaluated 140 patients with advanced carcinoma of the urothelial tract who, after a first-line platinum-based chemotherapy regimen, had relapsed up to one year following the initial treatment. Patients were randomized to receive either a combination of ramucirumab and docetaxel, docetaxel alone (n=45), or a combination of icrucumab and docetaxel. Treatment continued until disease progression or toxicity levels resulted in an interruption of treatment with one or more of the study medicines.
07:52 EDTSNY, NVOIIR Holdings to hold a conference
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07:38 EDTLLYBox to hold a user conference
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07:27 EDTLLYFDA and the Parental Drug Association to co-host a conference
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05:18 EDTSNYRegeneron and Sanofi announce of approval of Praluent in EU
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission has granted marketing authorization for Praluent for the treatment of bad cholesterol, known as low-density lipoprotein cholesterol, in certain adult patients with hypercholesterolemia. Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses as a single 1-milliter injection once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer. The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
September 25, 2015
18:59 EDTNVONovo Nordisk confirms FDA approval of Tresiba
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14:52 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
The U.S. FDA announced that it approved Tresiba and Ryzodeg 70/30 to improve blood sugar control in adults with diabetes mellitus. Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. Tresiba and Ryzodeg are manufactured by Novo Nordisk.
14:51 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
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07:22 EDTLLY, SNYEuropean Society for Medical Oncology to hold a conference
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