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News Breaks
May 19, 2014
16:10 EDTNVS, OPHTOphthotech, Novartis enter into ex-U.S. licensing, commercialization agreement
Ophthotech (OPHT) announced that the company has entered into an ex-US licensing and commercialization agreement with Novartis Pharmaceuticals (NVS) focused on the treatment of wet age-related macular degeneration, or AMD. Under the agreement, Ophthotech grants Novartis exclusive rights to commercialize Ophthotech’s lead product candidate, Fovista, in markets outside the United States while Ophthotech retains sole rights to commercialize Fovista in the U.S. Potential payments to Ophthotech under the agreement could total over $1B in upfront and milestone payments, not including future royalties. Ophthotech will continue to lead the global Fovista Phase 3 wet AMD pivotal clinical program which is expected to have initial, topline data available in 2016. Ophthotech will continue its lead role in the potential registration of Fovista in the U.S., while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the U.S. This collaboration continues the Fovista development strategy to remain agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. Separate injections of the anti-VEGF agent and Fovista would allow physicians to choose their preferred anti-VEGF agent for the combination therapy. The collaboration also provides for the potential development of a fixed combination delivery of a co-formulation of Fovista with a Novartis proprietary anti-VEGF product which would result in additional flexibility for physicians. Novartis will also seek to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.
News For OPHT;NVS From The Last 14 Days
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November 28, 2014
08:10 EDTNVSNovartis consensus estimates 'significantly' too low, says JPMorgan
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06:26 EDTNVSNovartis says LCZ696 granted accelerated assessment in Europe
Novartis announced that the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction. The company said, "The expedited review procedure is granted infrequently by the EMA and has never been awarded in the cardiovascular area until now." The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure, meaning a decision on EU approval is expected within 2015. Novartis expects to submit the file for marketing authorization in the European Union in early 2015. In the U.S., LCZ696 has been granted Fast Track designation by the FDA and a rolling submission is expected to be complete by the end of 2014.
November 26, 2014
14:38 EDTNVSNovartis to divest Habitrol nicotine patch to settle FTC charges over Glaxo jv
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November 25, 2014
10:00 EDTNVSOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 3M Company (MMM) initiated with an Underperform at RBC Capital... Ametek (AME) initiated with an Outperform at RBC Capital... AstraZeneca (AZN) initiated with an Outperform at Exane BNP Paribas... Bayer (BAYRY) initiated with a Neutral at Exane BNP Paribas... Carlisle (CSL) initiated with a Sector Perform at RBC Capital... Colfax (CFX) initiated with a Sector Perform at RBC Capital... Dover (DOV) initiated with a Sector Perform at RBC Capital... Eaton (ETN) initiated with a Sector Perform at RBC Capital... Emerson (EMR) initiated with a Sector Perform at RBC Capital... Evercore Partners (EVR) initiated with an Outperform at Macquarie... Fifth Street Asset (FSAM) initiated with a Buy at MLV & Co.... Flowserve (FLS) initiated with an Underperform at RBC Capital... General Electric (GE) initiated with an Outperform at RBC Capital... GlaxoSmithKline (GSK) initiated with an Underperform at Exane BNP Paribas... Grainger (GWW) initiated with a Sector Perform at RBC Capital... Hanesbrands (HBI) initiated with a Buy at UBS... Hercules Technology (HTGC) initiated with a Neutral at Macquarie... HomeStreet (HMST) initiated with a Neutral at Macquarie... Honeywell (HON) initiated with an Outperform at RBC Capital... IDEX Corp. (IEX) initiated with an Outperform at RBC Capital... Illinois Tool Works (ITW) initiated with a Sector Perform at RBC Capital... Ingersoll-Rand (IR) initiated with a Sector Perform at RBC Capital... ManTech (MANT) initiated with a Buy at Maxim... Novartis (NVS) initiated with an Outperform at Exane BNP Paribas... Nu Skin (NUS) initiated with a Neutral at Citigroup... Oppenheimer Holdings (OPY) initiated with a Neutral at Macquarie... Pentair (PNR) initiated with an Outperform at RBC Capital... Raymond James (RJF) initiated with a Neutral at Macquarie... Roche (RHHBY) initiated with an Outperform at Exane BNP Paribas... Roper Industries (ROP) initiated with an Outperform at RBC Capital... SPX Corp. (SPW) initiated with a Sector Perform at RBC Capital... Sanofi (SNY) initiated with an Outperform at Exane BNP Paribas... Tyco (TYC) initiated with an Outperform at RBC Capital... United Technologies (UTX) initiated with an Outperform at RBC Capital... WESCO (WCC) initiated with an Outperform at RBC Capital... Xylem (XYL) initiated with a Sector Perform at RBC Capital.
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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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 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 EDTNVSLeerink 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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