Shire Pharmaceuticals
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Shire Slumps After Lowering Revenue Outlook
May 3, 2013 8:16 am | News | CommentsIrish drugmaker Shire PLC said Thursday its net income fell in the first quarter, and it lowered its revenue forecast because sales of several of its drugs are under pressure. Sales of its ADHD drug Adderall XR have been sliding because of growing generic competition. They fell 10 percent to $99.8 million during the quarter.
Teva Gets FDA approval for Generic ADHD Drug
February 14, 2013 1:26 pm | News | CommentsTeva Pharmaceutical Industries Ltd. said Thursday that it received marketing approval for a generic version of Shire PLC's Adderall XR, a treatment for attention deficit hyperactivity disorder. The Food and Drug Administration approved Teva's generic in six strengths from 5 milligrams to 30 milligrams.
Impax and Shire Settle Litigation Concerning Supply of Authorized Generic Adderall XR®
February 8, 2013 8:15 am | News | CommentsImpax Laboratories, Inc. today announced that it has settled all pending litigation with Shire LLC and Shire Laboratories, Inc. (collectively Shire) relating to supply of its authorized generic Adderall XR® under the parties’ License and Distribution Agreement that was signed in January 2006. As part of the settlement, the parties will submit a stipulation of dismissal for entry by the Court.
Shire agrees to settle ADHD drug inquiry
February 1, 2013 2:57 pm | by The Associated Press | News | CommentsShire PLC said Friday it agreed to pay about $57.5 million to resolve a federal investigation into the marketing of its drugs for treating attention deficit hyperactivity disorder. The Irish company makes several ADHD drugs, including the former blockbuster Adderall XR, which was its top-selling...
Arrowhead and Shire Enter into Collaboration and License Agreement to Develop Peptide-Targeted Therapeutics
December 18, 2012 4:12 am | News | CommentsArrowhead Research Corporation, a targeted therapeutics company, today announced that it has signed a research collaboration and license agreement with Shire AG, to develop and commercialize targeted peptide-drug conjugates (PDCs) by utilizing Arrowhead’s human-derived Homing Peptide platform and Shire’s therapeutic payloads.
Shire and Boston Children's Hospital Enter Into Broad Research Collaboration
November 20, 2012 2:51 am | News | CommentsShire plc and Boston Children's Hospital today announced a three-year, broad research collaboration in rare diseases. The goal of the collaboration is to develop novel therapies to treat a number of rare pediatric diseases with high unmet medical need, thereby leveraging Boston Children's research expertise and Shire's development and commercialization capabilities.
AMRI Announces Five-Year Extension of API Supply Agreement With Shire
October 19, 2012 4:19 am | News | CommentsAMRI announced today that it has entered into a multi-year supply agreement for an undisclosed product with Shire US Manufacturing.
Shire Profits Boosted by Vyvanse Performance
August 2, 2012 6:18 am | by Matthew Dennis | News | CommentsShire reported Wednesday that second-quarter net income reached $238 million, up from $206 million in the year-ago period amid higher sales of the attention-deficit hyperactivity disorder (ADHD) drug Vyvanse, although the figure fell short of analysts' estimates of $255 million.
Watson Confirms Lialda Patent Challenge
May 10, 2012 4:05 am | News | CommentsWatson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Mesalamine Delayed-release Tablets, 1.2g.
Shire First Quarter Profit Grows as ADHD Drug Sales Rise
April 27, 2012 4:32 am | News | CommentsNEW YORK (AP) — Irish drugmaker Shire PLC said Thursday its profit increased 13 percent in the first quarter on greater sales of its attention deficit hyperactivity disorder drugs and treatments for rare genetic ailments.
Shire to Acquire Assets of Pervasis Therapeutics
April 13, 2012 4:04 am | News | CommentsShire plc has signed an agreement to acquire substantially all the assets of Pervasis Therapeutics. Shire will provide Pervasis with an upfront payment, plus potential post-closing milestone payments that are dependent on Shire's achievement of certain clinical development, regulatory and sales targets.
Shire Will Pay Up to $325M to Buy FerroKin
March 16, 2012 4:20 am | News | CommentsNEW YORK (AP) — Irish drugmaker Shire plc said Thursday it will pay $100 million to acquire FerroKin BioSciences Inc., a company that is developing a drug that helps the body eliminate excess iron.
Shire Announces European Approval of Manufacturing Facility for VPRIV
February 22, 2012 3:00 am | News | CommentsShire announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has approved the production of VPRIV (velaglucerase alfa) in its new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, MA.
Shire Acquires US Rights to Resolor
January 10, 2012 3:05 am | News | CommentsShire plc announced today that it has acquired the rights to develop and market Resolor (prucalopride) in the United States in an agreement with Janssen Pharmaceutica N.V.
Shire's Vyvanse Performs Well in Phase II Trial
December 9, 2011 5:13 am | by Lianne Dane | News | CommentsShire announced Thursday that a mid-stage trial of Vyvanse (lisdexamfetamine) as adjunctive therapy in patients with major depressive disorder (MDD) met its primary endpoint of providing "superior" improvements in a measure of cognition compared to placebo.
FDA, Shire Reach Agreement on ProAmatine Trials
December 5, 2011 3:43 am | News | CommentsShire plc has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH).
Shire Seeks U.S., EU Approval of New Facility
November 23, 2011 4:41 am | by the Associated Press | News | CommentsIrish drugmaker Shire PLC has filed an application with U.S. and European regulators to produce its Gaucher disease drug at a new manufacturing site in Massachusetts, saying the move will give it flexibility to meet global demand for treatments of rare diseases.
Shire Files Lawsuits Against Watson and Roxane
July 7, 2011 4:31 am | News | CommentsShire plc has filed lawsuits in the U.S. District Court for the District of New Jersey against Roxane Laboratories, Inc., and in the U.S. District Court for the Central District of California against Watson Laboratories, Inc., respectively, for infringement of certain of Shire's VYVANSE patents.
Multiple Benefits From Single Use Project
June 16, 2011 12:16 pm | by Jeff Reinke, Editorial Director | Articles | CommentsShire Human Genetic Therapies’ Atlas Project recognized with Honorable Mention in ISPE/INTERPHEX/Pharmaceutical Processing Facility of the Year Award.
Cubist Pharma Rises on Talks of Sale to Shire
May 27, 2011 4:47 am | News | CommentsNEW YORK (AP) — Shares of Cubist Pharmaceuticals Inc. rose on speculation the company may be acquired by Irish drugmaker Shire PLC.
Shire Files Lawsuit Against Watson Pharmaceuticals
April 6, 2011 4:37 am | News | CommentsShire plc’s subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and its subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of Shire's U.S. Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096 and U.S. Patent No. 6,913,768 and also for breach of contract.
Shire Files Suit Against Impax and Watson
December 3, 2010 3:33 am | News | CommentsShire plc’s subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Northern District of California against Impax Laboratories, Inc. and Watson Pharmaceuticals
FDA Approves Vyvanse Capsules CII for the Treatment of ADHD in Adolescents
November 15, 2010 4:23 am | News | CommentsShire plc today announced that the FDA has approved the prescription medication Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17.
Shire And Acceleron to Collaborate on Orphan Muscle Diseases
September 9, 2010 4:23 am | News | CommentsShire plc has announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB (ActRIIB) class of molecules being developed by Acceleron Pharma Inc.,
European Commission Approves Shire's VPRIV(R) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease
August 27, 2010 4:50 am | News | CommentsThe European Commission has granted marketing authorization for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.
