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News Breaks
May 19, 2014
16:10 EDTOPHT, NVSOphthotech, 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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February 12, 2016
16:09 EDTNVSNovartis reports 5.57% stake in Arrowhead
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February 11, 2016
07:17 EDTNVSLeerink to hold a conference
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05:35 EDTNVSSandoz reports EMA acceptance of MAA for biosimilar pegfilgrastim
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency, or EMA, has accepted their Marketing Authorization Application, or MAA, for its biosimilar to Amgen's EU-licensed Neulasta - a long-acting recombinant human granulocyte colony-stimulating factor, or G-CSF. Sandoz is seeking approval for the same indication as the reference product.
February 9, 2016
11:18 EDTNVSOptions with increasing call volume; CERS WYN NVS ZIOP PZM PI OC DB MLM
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February 8, 2016
09:38 EDTNVSCigna enters into outcomes-based contract with Novartis
Cigna (CI) has entered into an outcomes-based contract with the pharmaceutical company Novartis (NVS) for the drug Entresto, which was approved by the FDA for the treatment of heart failure with reduced ejection fraction. The pay-for-performance agreement ties the financial terms to how well the drug improves the relative health of Cigna's customers. The primary metric is reduction in the proportion of customers with heart failure hospitalizations. This agreement is effective for Cigna's commercial business. Entresto is a preferred brand subject to prior authorization review. The prior authorization process is part of utilization management to help control prescription drug costs and ensure coverage of the most appropriate drug therapies.
06:28 EDTNVSPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. 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
February 7, 2016
14:27 EDTNVSNovartis' somatic cell therapy receives orphan designation
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February 4, 2016
07:23 EDTNVSGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 2, 2016
11:14 EDTNVSNovartis management to meet with Jefferies
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07:42 EDTNVSPressure mounts on big pharma names to shrink, sharpen focus, FT says
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