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The Lead

Shire Recalls One Batch of Gaucher Disease Drug

March 14, 2014 1:48 pm | News | Comments

Shire is recalling one batch of its Gaucher disease treatment Vpriv because particulate matter was discovered in some vials of the drug.                    

Shire Announces FDA Approval of VPRIV Manufacturing Facility

February 14, 2014 10:39 am | News | Comments

Shire has announced that the FDA has approved the production of VPRIV drug substance (...

Shire Ends Vyvanse Development Program

February 7, 2014 8:08 am | News | Comments

Shire has announced top-line results from two pivotal Phase 3 investigational studies evaluating...

Shire Nears Completion of $4.2B ViroPharma Deal

January 24, 2014 11:10 am | by The Associated Press | News | Comments

Shire PLC has successfully completed its $4.2 billion tender offer for the rare disease...

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Susan Kilsby to Succeed Matthew Emmens as Chairman of Shire

January 23, 2014 9:56 am | News | Comments

Shire plc today announces that Matthew Emmens will retire as Non-Executive Chairman and Susan Kilsby, Chairman of Shire's Audit, Compliance & Risk Committee will succeed him after the conclusion of Shire's AGM on 29 April 2014.   

Shire Sells Foot Ulcer Treatment to Organogenesis

January 17, 2014 8:07 am | by The Associated Press | News | Comments

The Irish drugmaker booked no upfront payment with the sale of the treatment, Dermagraft, but it said Friday it could receive up to $300 million in cash if Organogenesis meets certain sales targets between now and 2018.     

Shire Buys ViroPharma in $4.2B Deal

November 11, 2013 8:43 am | News | Comments

Shire says it is buying the rare disease biopharmaceutical company ViroPharma in a deal worth $4.2 billion. ViroPharma makes CINRYZE, which treats hereditary angioedema, a disease characterized by recurrent attacks of swelling of the skin or mucous membranes.

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Questcor Names Former Shire CEO to Board

June 11, 2013 8:26 am | News | Comments

Biopharmaceutical company Questcor Pharmaceuticals Inc. said Monday that the recently retired CEO of Shire PLC, Angus C. Russell, has been added to its board. Russell was CEO of Shire, also a biopharmaceutical company, for five years. Before that, he was an executive at pharma companies ICI, Zeneca and AstraZeneca.

Shire Settles Patent Dispute with Teva

June 3, 2013 8:30 am | News | Comments

Shire LLC said Friday that it has settled its patent dispute with Teva Pharmaceuticals USA Inc. over Teva's efforts to sell a generic version of its drug used for treatment of attention deficit hyperactivity disorder.The settlement allows Teva to market a generic version of Shire's Intuniv extended release tablets or generic versions supplied by Shire.

Shire Slumps After Lowering Revenue Outlook

May 3, 2013 8:16 am | News | Comments

Irish 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.

Shire Acquires Premacure AB

March 12, 2013 8:35 am | News | Comments

Shire plc, announces that it has acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company developing a protein replacement therapy, currently in Phase II development,  for the prevention of retinopathy of prematurity (ROP). ROP is a rare and potentially blinding eye disorder that primarily affects premature infants and is one of the most common causes of visual loss in childhood.

Shire 4Q Profit Falls 84% as Costs Climb

February 14, 2013 1:38 pm | by The Associated Press | News | Comments

Shares of Shire PLC sank Thursday morning after the Irish drugmaker said its fourth-quarter earnings tumbled 84 percent on climbing costs and generic competition for its attention deficit hyperactivity disorder drug. The Dublin company earned $42 million, or 22 cents per share, in the three months that ended Dec. 31.

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Teva Gets FDA approval for Generic ADHD Drug

February 14, 2013 1:26 pm | News | Comments

Teva 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 | Comments

Impax 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 | Comments

Shire 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 | Comments

Arrowhead 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 | Comments

Shire 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.

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AMRI Announces Five-Year Extension of API Supply Agreement With Shire

October 19, 2012 4:19 am | News | Comments

AMRI 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 | Comments

Shire 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 | Comments

Watson 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 | Comments

NEW 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 | Comments

Shire 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 | Comments

NEW 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 | Comments

Shire 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 | Comments

Shire 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 | Comments

Shire 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 | Comments

Shire 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 | Comments

Irish 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 | Comments

Shire 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.

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