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News Breaks
April 11, 2014
07:06 EDTAUXL, SNY, VVUSVIVUS announces avanafil clinical data presentation
VIVUS (VVUS) announced that a poster describing results of a clinical study examining onset of action of avanafil will be presented during the 29th Annual European Association of Urology Congress. STENDRA, or avanafil, is approved by the FDA in the U.S. for the treatment of erectile dysfunction. VIVUS has granted Auxilium Pharmaceuticals (AUXL) exclusive marketing rights to STENDRA in the U.S. and Canada. Auxilium is in the early stages of commercializing STENDRA in the U.S. SPEDRA is the trade name for avanafil in the European Union and is approved by the European Medicines Agency for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to Sanofi (SNY) to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.
News For VVUS;SNY;AUXL From The Last 14 Days
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March 30, 2015
16:07 EDTVVUSVIVUS continues talks with U.S., EU over Qsymia
VIVUS announced an operational update, including certain key corporate decisions and plans regarding Qsymia capsules CIV. These plans include further investments in high-value, consumer-focused digital media projects in support of obesity education and Qsymia, and focusing the Qsymia field sales organization of approximately 100 territories on the most productive target areas. Management will continue discussions with U.S. and EU regulatory authorities regarding Qsymia development and potential cost-saving measures related to the planned cardiovascular outcomes trial, or CVOT, and will aim to further improve corporate efficiency and control costs while maintaining and extending the value of avanafil. VIVUS plans to discuss with U.S. regulatory authorities and key consultants potential cost-saving alternatives with respect to the Qsymia CVOT, known as AQCLAIM. The company is also in the process of pursuing approval for Qsymia in the EU and other key countries, as well as new indications in other chronic diseases such as obstructive sleep apnea, or OSA, and type 2 diabetes. VIVUS plans to optimize spending while pursuing these potential objectives.
11:18 EDTSNYPDL BioPharma rises after Cerdelga approved in Japan
Genzyme, a Sanofi (SNY) company, announced earlier that the Ministry of Health, Labor and Welfare has granted marketing approval for Cerdelga as oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. PDL BioPharma (PDLI) announced on November 6 that it has acquired a portion of the University of Michigan's worldwide royalty interest in Cerdelga for $65.6M. Under the terms of the royalty agreement, PDL will receive 75% of all royalty payments due under U-M's license agreement with Genzyme until expiration of the licensed patents, excluding any patent term extension. The royalty rate used to calculate the royalties to be paid by Genzyme to U-M was not disclosed by the parties. Shares of PDL BioPharma are up 12c, or 1.8%, to $7.16 in morning trading.
11:01 EDTSNYSanofi's Genzyme says Cerdelga capsules approved in Japan
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March 27, 2015
14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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March 26, 2015
11:13 EDTSNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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March 23, 2015
09:45 EDTSNYUBS to hold a field trip
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March 19, 2015
07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:12 EDTAUXLInnocoll appoints James Tursi, M.D., as Chief Medical Officer
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March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink

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