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News Breaks
March 7, 2014
05:40 EDTINCY, NVSNovartis announces Phase III study for Jakavi meets primary endpoint
Novartis announced that a pivotal Phase III trial of Jakavi, ruxolitinib, compared to best available therapy has met its primary endpoint of maintaining hematocrit control without the need for phlebotomy, a procedure to remove blood from the body to reduce the concentration of red blood cells, and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea. The safety profile of Jakavi was generally consistent with previous studies based on initial review of the data. Data from the study will be presented at an upcoming medical congress and submitted to worldwide regulatory authorities this year.
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November 25, 2014
06:29 EDTNVSMallinckrodt says Questcor received subpoena from FTC in June
Mallinckrodt (MNK) disclosed in its quarterly regulatory filing that on June 11, Questcor received a subpoena and Civil Investigative Demand from the Federal Trade Commission seeking documentary materials and information regarding the FTC’s investigation into whether Questcor’s acquisition of certain rights to develop, market, manufacture, distribute, sell and commercialize Synacthen Depot from Novartis (NVS) violates the antitrust laws.
05:26 EDTNVSNovartis initiated with an Outperform at Exane BNP Paribas
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05:16 EDTNVSNovartis announces extension to FDA review period for MML compound LBH589
Novartis announced that the FDA has extended their priority review period by up to three months for the new drug application, or NDA, of LBH589 in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma. The NDA for LBH589 was submitted to the FDA in March. In May, the FDA granted priority review status to LBH589, reducing the standard 12-month review period to eight months. The extension to the LBH589 NDA review period follows an FDA Oncologic Drugs Advisory Committee meeting earlier this month.
November 24, 2014
08:02 EDTNVSReceptos price target raised to $186 from $130 at Leerink
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07:33 EDTINCYBrean Capital to hold a summit
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06:32 EDTNVSGSK investors expected to vote on Novartis deal in December, Reuters reports
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05:13 EDTNVSNovartis drug Signifor approved in EU
Novartis announced that the European Commission has approved Signifor as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. Next-generation SSA Signifor offers the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs. Additional regulatory applications for the new long acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the United States.
November 21, 2014
05:22 EDTNVSNovartis Cosentyx receives positive CHMP opinion
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November 20, 2014
08:25 EDTINCYIncyte management to meet with UBS
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November 17, 2014
16:52 EDTNVSNovartis' LCZ696 could change course of heart failure for patients, study shows
New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction shows it has the potential to change the course of the disease for patients. In August, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly: reduced the risk of dying suddenly by 20% in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden; reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively; reduced hospitalizations for a cardiovascular reason or for any reason both by 16%; reduced the need for more intense treatment at home by 16%; reduced emergency room visits because of rapid symptom worsening by 30%.
11:06 EDTINCY, NVSLeerink biotech analysts hold an analyst/industry conference call
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November 16, 2014
15:07 EDTNVSNovartis says arthritis drug secukinumab met primary endpoint
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November 14, 2014
14:53 EDTNVSCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTNVSAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
13:32 EDTNVS, INCYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTNVS, INCYLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTNVS, INCYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
November 12, 2014
11:17 EDTINCY, NVSLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:18 EDTNVSUBS to hold a conference
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07:58 EDTNVSGenVec expects 2014 cash burn between $6M-$7M from Novartis collaboration
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