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News Breaks
November 4, 2009
07:15 EDTSHPGY
theflyonthewall.com: Shire's velaglucerase alfa gets FDA priority review for type 1 Gaucher Disease
Shire plc announced that the U.S. FDA has granted Priority Review for the New Drug Application, or NDA, for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act, or PDUFA. In the U.S., patients continue to be enrolled in an FDA-approved treatment protocol, under which Gaucher patients receive velaglucerase alfa prior to commercialization. Shire has also engaged with national and regional authorities outside the U.S. and patients are receiving velaglucerase alfa through pre-approval access programs. Shire confirms it is on track with its filing of the Marketing Authorization Application, or MAA, in the EU for 2009. :theflyonthewall.com



News For SHPGY From The Last 14 Days
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February 10, 2012
08:00 EDTSHPGY
theflyonthewall.com: Shire price target raised to $124 from $114 at RW Baird

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February 9, 2012
10:01 EDTSHPGY
theflyonthewall.com: Shire says Genzyme claim on Fabrazyme dosing "misleading"

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09:57 EDTSHPGY
theflyonthewall.com: Shire says not planing European sales force expansion for Vyvanse

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09:57 EDTSHPGY
theflyonthewall.com: Shire says sees 2012 gross margins "marginally lower"
Says will reflect the FY impact of ABH acquisition. :theflyonthewall.com
09:56 EDTSHPGY
theflyonthewall.com: Shire says expects to deliver good earnings growth in 2012

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07:20 EDTSHPGY
theflyonthewall.com: Shire sees FY12 sales growth in low to mid teens range

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07:17 EDTSHPGY
theflyonthewall.com: Shire reports Q4 adjusted EPS $1.51 vs. consensus $1.37
Reports Q4 revenue $1.14B vs. consensus $1.13B. :theflyonthewall.com

February 7, 2012
12:20 EDTSHPGY
theflyonthewall.com: Shire's Vyvanse gets FDA approval as maintenence treatment in adults with ADHD
Shire announced that the FDA approved the prescription medication Vyvanse Capsules as a maintenance treatment for adults with ADHD. The approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults who were receiving treatment with Vyvanse for a minimum of 6 months prior to enrolling in the study. Significantly more patients treated with Vyvanse maintained ADHD symptom control compared with placebo as determined by the proportion of patients who met criteria for relapse of symptoms at end point during the six-week randomized double-blind withdrawal phase of the study. This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients ages 6 and above. :theflyonthewall.com

February 1, 2012
07:24 EDTSHPGY
theflyonthewall.com: Shire and Sangamo BioSciences collaborate on therapeutics development

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