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News Breaks
January 23, 2013
14:28 EDTNVSNovartis: FDA expands the approved use of Exjade
The U.S. Food and Drug Administration expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion- dependent thalassemia. NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs. The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade. The agency previously cleared FerriScan for measuring liver iron concentration (LIC), but its use in Exjade clinical studies to select patients for therapy, and to manage therapy, defined its role as an imaging companion diagnostic necessary for Exjade's safe and effective use. FerriScan measures LIC non-invasively using magnetic resonance imaging. Exjade is marketed by East Hanover, N.J.-based Novartis (NCS). FerriScan is marketed by Resonance Health, based in Australia.
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April 16, 2014
13:51 EDTNVSAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
11:19 EDTNVSNovartis launches new eye care products facility in Singapore, Nikkei says
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April 15, 2014
07:35 EDTNVSAlnylam outlook not affected by Novartis decision, says JMP Securities
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07:22 EDTNVSNovartis to Shire said to mull offers for ThromboGenics, Bloomberg says
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06:36 EDTNVSRanbaxy inspection failures add $900M to heart drug costs, Bloomberg says
A gap in U.S. patent law has kept cheap copies of Novartis' (NVS) heart drug Diovan off the market for 18 months, which has cost U.S. consumers and insurers as much as $900M in possible savings, reported Bloomberg. Ranbaxy (RBXLY) is the only company permitted to sell a generic version of Diovan, and hasn’t been able to manufacture and market them after four factories it runs in India failed U.S. inspections. Reference Link
06:32 EDTNVSPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers 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). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
14:42 EDTNVSAlnylam slips after Novartis reportedly cuts back RNAi development
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11:48 EDTNVSNovartis significantly reducing RNAi development efforts, FierceBiotech says
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April 9, 2014
07:09 EDTNVSReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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April 8, 2014
07:22 EDTNVSCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 7, 2014
07:27 EDTNVSAmerican Association of Cancer Research to hold annual meeting
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05:32 EDTNVSNovartis Bexsero vaccine receives FDA Breakthrough Therapy designation
Novartis announced that Bexsero, Meningococcal Group B Vaccine, has received a Breakthrough Therapy designation from the FDA. Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. Novartis plans to file for U.S. licensure of Bexsero as early as Q2; exact timing will depend on guidance from the FDA. This is the fourth Breakthrough Therapy designation for Novartis, underscoring leadership in developing innovative therapies and vaccines. This announcement comes on the heels of a landmark decision from regulators in the UK, where the Joint Committee on Vaccination and Immunisation recommended the inclusion of Bexsero in the country's National Immunisation Programme for routine use in infants from two months of age.
April 3, 2014
08:06 EDTNVSApricus Biosciences granted national phase approval for Vitaros in Luxembourg
Apricus Biosciences (APRI) announced that the Ministry of Health of Luxembourg has granted national phase approval to Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction. The company has now received a total of nine national phase approvals for Vitaros®, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom following its broad approval by European health authorities in June 2013. Apricus has an exclusive commercialization partnership in place with Hexal AG, an affiliate within the Sandoz Division of the Novartis (NVS), for the commercialization of Vitaros in several European countries, including Luxembourg.
06:26 EDTNVSNovartis placing temporary moratorium on all IIT funding in Japan
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06:26 EDTNVSNovartis announces third-party internal review of IITs
06:25 EDTNVSNovartis appoints Dirk Koshce as head of Novartis Pharmaceuticals
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05:31 EDTNVSNovartis says data on 19 investigational compounds to be presented
Novartis announced that early stage data on 19 investigational compounds in its oncology pipeline will be presented at the annual meeting of the American Association of Cancer Research. Among the data being presented are single agent and combination studies with key investigational compounds in the Novartis Oncology breast cancer development program, including an early phase study of the CDK4/6 inhibitor LEE011 and PI3K inhibitors BKM120 and BYL719. LEE011 and BKM120 are currently in Phase III and BYL719 is in Phase I trials for the treatment of advanced breast cancer.
April 2, 2014
06:34 EDTNVSNovartis price target raised to $93 from $88 at Leerink
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