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News Breaks
May 9, 2014
14:03 EDTAGN, SNY, JNJAllergan rebuffed by white knights J&J, Sanofi, Bloomberg reports
News For AGN;JNJ;SNY From The Last 14 Days
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April 1, 2015
14:42 EDTJNJPiper Jaffray biopharma analyst holds an analyst/industry conference call
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March 30, 2015
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 29, 2015
14:06 EDTJNJJ&J announces study findings of paliperidone palmitate published in JAMA
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March 27, 2015
15:14 EDTJNJJohnson & Johnson not likely to buy Intuitive Surgical, says BofA/Merrill
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14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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09:59 EDTJNJJohnson & Johnson to collaborate with Google to advance surgical robots
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06:46 EDTJNJContact lens makers, discounters battling over price setting, NY Times says
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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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07:29 EDTJNJLeerink to hold booth tours
Leerink Booth Tours at AAOS 2015 will be held in Las Vegas on March 25-26.
March 24, 2015
13:24 EDTJNJContact lens manufacturers accused of price-fixing, Bloomberg says
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07:45 EDTJNJFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
16:14 EDTAGNPershing Square liquidates stake in Allergan
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09:45 EDTSNYUBS to hold a field trip
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09:03 EDTJNJ, AGNLeerink analysts hold a meeting with a conference call hookup
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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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