Shire has announced that the FDA has approved the production of VPRIV drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility in Lexington, Massachusetts. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
Shire has announced top-line results from two pivotal Phase 3 investigational studies evaluating...
Shire PLC has successfully completed its $4.2 billion tender offer for the rare disease...
Shire plc today announces that Matthew Emmens will retire as Non-Executive Chairman and Susan...
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 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.
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 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.
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 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.
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.
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 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 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 TherapeuticsDecember 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 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 announced today that it has entered into a multi-year supply agreement for an undisclosed product with Shire US Manufacturing.
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 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.
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 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.
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 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 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 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.
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).
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 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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