Shire presents study findings on its ADHD treatments at psychiatric meeting Oct. 29-30 Oct 30, 2009
HONOLULU October 29, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV (guanfacine) Extended Release Tablets, Vyvanse (lisdexamfetamine dimesylate) Capsules CII, and Daytrana (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu. "Shire is... (EurekAlert!)
Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease Oct 28, 2009
FOSRENOL(R) (lanthanum carbonate) Now Approved in the EU to Treat hyperphosphataemia greater than 1. 78mmol/L in Chronic Kidney Disease Patients Not on Dialysis. (Canada Newswire)
Vyvanse Capsules CII administration through 2 routes demonstrated similar pharmacokinetic profile Oct 23, 2009
PHILADELPHIA October 22, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally. Specifically, the overall rate and extent of... (EurekAlert!)
Data From a Head-to-Head Crossover Study Evaluating FOSRENOL(R) and Sevelamer Published Today Oct 7, 2009
Direct Comparison of the Two non-Calcium Phosphate Binders Gives new Insights Into Relative Efficacy (Canada Newswire)
FDA approves INTUNIV (guanfacine) extended release tablets for ADHD in children and adolescents Sep 6, 2009
PHILADELPHIA September 03, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved... (EurekAlert! -- Business News)
Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials Sep 1, 2009
CAMBRIDGE, Massachusetts, September 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: ), the global specialty biopharmaceutical company, today reported that it has completed its submission of a New Drug Application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the U.S. Food and Drug Administration (FDA). The Company also announced positive results from the final two Phase III studies of velaglucerase alfa,... (PR Newswire)
Southern Health Partners considered for inmate healthcare Aug 19, 2009
Southern Health Partners (SHP) is interested in providing Benton County with inmate medical care. If chosen, SHP will offer a program that will provide medical care for inmates without having to take the inmate out of the jail facility ... SHP has extensive experience in providing medical care in the jail and prison setting. (Camden Chronicle, TN)
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA Aug 3, 2009
LEXINGTON, Massachusetts, August 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: ), the global specialty biopharmaceutical company, today reported positive results from the first of three Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. The Company also announced that the U.S. Food and Drug Administration (FDA) has accepted its treatment protocol for velaglucerase alfa and that Shire has begun its rolling... (PR Newswire)
FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents Jul 28, 2009
PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: ), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. (PR Newswire)
Vyvanse CII significantly improved ADHD symptoms for children 13 hours after administration Jul 23, 2009
PHILADEPHIA July 22, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 from the first time point measured (1. 5 hours) up to the last time point assessed (13... (EurekAlert!)
Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease Jul 16, 2009
LEXINGTON, Massachusetts, July 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: ), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA.. (PR Newswire)
VYVANSE CII provided significant efficacy at 14 hours in adults with ADHD Jul 2, 2009
Hollywood, FL July 1, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a Phase 3b study that found VYVANSE (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these... (EurekAlert!)
FDA approves labeling change for VYVANSE CII to efficacy at 13 hours postdose in children with ADHD Jun 2, 2009
Philadelphia, PA June 1, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.... (EurekAlert! -- Business News)
Shire's INTUNIV (Guanfacine) extended release in children with ADHD and oppositional symptoms May 19, 2009
San Francisco, CA May 18, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced new findings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo controlled trial met its primary objective, which was to evaluate the effects of INTUNIV on oppositional symptoms in children aged 6 to 12 years with a diagnosis of ADHD and the presence of oppositional symptoms. (EurekAlert!)
How healthy is your practice? Apr 30, 2009
Kent based accountancy practice, Stephen Hill Partnership (SHP) worked with Water Wellpoint to run a wellbeing day for its employees in January 2009, providing health checks and advice on health issues. A Water Wellpoint Kiosk was installed at SHPs offices in Gillingham for a day, offering the company a chance to engage staff in their wellbeing ... Weve got a great bunch of staff and I wanted to show them we are here and helping them, explained Lance Clifton, a director at SHP. Its in my... (Accounting Web, UK)
GlaxoSmithKline and Shire Enter Agreement to Co-Promote Vyvanse(R) (lisdexamfetamine dimesylate) CII for Adult Attention Deficit Hyperactivity Disorder Apr 1, 2009
RESEARCH TRIANGLE PARK, N.C., March 31 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc (NYSE: ) has entered into a co-promotion agreement with Shire plc (LSE: SHP, Nasdaq: ) for Vyvanse(R), to help improve the recognition and treatment of adult Attention Deficit Hyperactivity Disorder (ADHD). This 3-year agreement covers the United States only and will add an important product to the GSK Neurosciences portfolio. (PR Newswire)
Non-safety-related voluntary market withdrawal of a limited portion of DAYTRANA® (methylphenidate transdermal system) patches announced Mar 24, 2009
FOR IMMEDIATE RELEASE -- March 20, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch DAYTRANA (the lots of DAYTRANA patches affected by this action are listed below). Shire is taking this action because some DAYTRANA patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the... (U.S. Food and Drug Administration -- Alerts)
Shuttle races toward space station Mar 16, 2009
Launch delays and the need to be out by the time a Russian shp arrives have cut the mission shourt, with four scheduled spacewalks pared to three. The crew will also deliver supplies and hardware, most notably replacing a broken machine that turns urine into drinking water. (WCAX.com, VT)
Shire Announces Launch of FOSRENOL(R) in Japan Mar 11, 2009
DUBLIN, March 11 /CNW/ - Availability of Non-Calcium, Non-Resin FOSRENOL(R) Gives New Therapy Choice for the Management of Hyperphosphataemia in End-Stage Renal Disease Patients(1) in Japan Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announces the Japanese launch of FOSRENOL(R) (lanthanum carbonate), which is now available to prescribers and patients in Japan through Shire's strategic alliance partner Bayer Yakuhin Ltd. FOSRENOL is the first... (Canada Newswire)
Shire to Enter European ADHD Market With the Acquisition of EQUASYM(R) IR and XL Feb 20, 2009
PHILADELPHIA and DUBLIN, February 20 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: ), the global specialty biopharmaceutical company, announces that it has signed an agreement with UCB to acquire the worldwide rights to EQUASYM(R) IR and XL (methylphenidate hydrochloride) (excluding the USA, Canada and Barbados) used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). EQUASYM XL is approved and marketed in 10 countries (outside the USA, Canada, and Barbados), and... (PR Newswire)
