Navigation Links
Shire Continues to Deliver Excellent Growth From Core Products
Date:10/30/2009

17), and on a US GAAP basis diluted earnings per ADS were $0.33 (Q3 2008: $(0.20)). - During the first three quarters of 2009 Shire has generated Non GAAP diluted earnings per ADS of $2.38 ($1.74 on a US GAAP basis). THIRD QUARTER HIGHLIGHTS AND RECENT DEVELOPMENTS Products VYVANSE - for the treatment of Attention Deficit and Hyperactivity Disorder ("ADHD") - Following a review of governing statutory and regulatory standards and public comments, the US Food and Drug Administration ("FDA") has affirmed its prior decision to grant five-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate. The five-year exclusivity period for VYVANSE expires on February 23, 2012. As a consequence of this decision, the FDA appropriately refused to file the Abbreviated New Drug Application submitted by Actavis Elizabeth, LLC ("Actavis") for generic lisdexamfetamine dimesylate in January 2009. VYVANSE is covered by US patents which remain in effect until June 29, 2023. INTUNIV(TM) - for the treatment of ADHD in children and adolescents in the US - On September 3, 2009 Shire announced that it received approval from the FDA for INTUNIV Extended Release Tablets for the treatment of ADHD in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily non-scheduled formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. - Once-daily INTUNIV is expected to be widely available in US pharmacies in November 2009 and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg). INTUNIV will be marketed in the US by the existing Shire ADHD sales team of nearly 600 representatives. FOSRENOL(R) - for the treatment of pre-dialysis chronic kidney disease ("CKD") in the EU - Shire has received approval through the European Mutual Rec
'/>"/>
SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... N.C. , Dec. 19, 2014 ... consumer research and marketing communication tools are essential ... globally competitive – consequently consumers, desires, preferences, and ... this environment, market research groups across all industries ... marketing communication tools. However, the adoption of new ...
(Date:12/19/2014)... NEW YORK , Dec. 18, 2014 ... meals, addressing hearing health was forgotten. But Audicus ... resolve to hear better this new year. ... condition facing the aging population, though it is often ... one in four has a hearing aid, mainly due ...
(Date:12/19/2014)... 18, 2014 Capnia, Inc. (NASDAQ: ... medical diagnostics based on its proprietary Sensalyze™ Technology ... announced financial results for the third quarter and ... "Following the completion of our initial public offering ... the recently initiated CoSense® commercial launch," said Anish ...
Breaking Medicine Technology:Study Uncovers New Tools and Techniques for Understanding Consumer Decision Making 2Audicus Will Help People Resolve to Hear Better in 2015 2Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8
(Date:12/21/2014)... AlignLife of Norton Shores is spreading ... same time helping people get their health back. Mission ... to serving those persons in Muskegon County who are unable ... quality of life. Dr. Michael Rykse wanted to do a ... community and he knew he found that when he heard ...
(Date:12/21/2014)... 21, 2014 SCI explores ... issues and systemic barriers for disabled athletes with ... Scheidies has a condition called juvenile macular degeneration, where ... how he adapted his athletic ambitions to his vision ... in triathlon to pioneer the way for other blind ...
(Date:12/21/2014)... CA (PRWEB) December 21, 2014 The Oncology ... drive in the Santa Ana and Whittier offices. The Hope ... brighten the lives of patients and their families during the ... reach out to approximately 70 children between both offices. This ... the help of Target’s community service team, store managers and ...
(Date:12/20/2014)... (PRWEB) December 21, 2014 MissyDress, a ... for all prom lovers. The business has drastically cut ... prom dresses to everyone until Jan. 30, 2015. Many ... dresses, sweetheart dresses, V-neck dresses, lace dresses, and more. ... are not there every day. Whether A-line princess prom ...
(Date:12/20/2014)... New York, NY (PRWEB) December 20, 2014 ... ) that allege a metal-on-metal version of the ... move forward in state and federal courts, Bernstein ... in New Jersey’ Bergen County Superior Court on ... were permitted to begin deposition of plaintiffs on ...
Breaking Medicine News(10 mins):Health News:AlignLife of Norton Shores Makes a Brighter Christmas for Kids in Muskegon 2Health News:Disability in Sports on SCI TV with Triathlon World Champ Aaron Scheidies 2Health News:Disability in Sports on SCI TV with Triathlon World Champ Aaron Scheidies 3Health News:MissyDress: The Prices of Prom Dresses Just Reduced 2Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 2Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 3Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 4
... Researchers at the Washington University School of Medicine in ... kick the butt by revealing that smoking interferes ... on a mouse model and found that cigarette smoking ... and delays healing following ligament repair surgery. ...
... Scientists at University of Alabama at Birmingham (UAB) have ... bacteria RNA and that in human RNA , a ... less antibiotic resistance. ,The new findings have ... Dmitry Vassylyev, Professor of Biochemistry and Molecular Genetics. ...
... Wednesday vetoed for a second time a bill seeking ... saying it violates the sanctity of human life. Risking ... by US lawmakers to overturn his earlier prohibition against ... destruction. ,It is only the third time ...
... of a major South Korean university is planning to bar ... drinking. Oh Myung, president of Seoul's Konkuk University, told ... extra points to non-smoking applicants. ,"I will definitely ... school," he was quoted as saying in an interview. ...
... report in the New England Journal of Medicine,treating hepatitis B ... are also infected with HIV to become resistant to two ... , the researchers reported that a patient infected with ... developed a mutant strain of HIV that is resistant to ...
... Pancreatic cancer(PC) has the poorest prognosis of all cancers: the ... 5% and on average , patients who have been diagnosed with ... modus operandi of cells is well known: the genes (DNA) are ... orders. Those orders are transmitted in the form of messages (RNA), ...
Cached Medicine News:Health News:Smoking Hampers Healing of the Ligament 2Health News:Scientists Trace New Pathway That may Stem Antibiotic Resistance 2Health News:Bush Again Vetoes Embryonic Stem Cell Research Bill 2Health News:Challenges in Entecavir Drug Treatment 2Health News:New Tumor Markers for Pancreatic Cancer 2
Large....
These products are supplied non-sterile and must be sterilized before use. For insertion through the smokevac and nezhat-dorsey trumpet valve in conjunction with the universal instrument insert adapt...
... Utilizing breakthrough electro-optical and rotary ... SUPRA is capable of obtaining ... pupils as narrow as 2.0mm. ... precise diagnostic results when dealing ...
Sterile perfluorocarbon for intraocular Application....
Medicine Products: