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...
Shire LLC said Friday that it has settled its patent dispute with Teva Pharmaceuticals USA Inc....
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.
NEW YORK (AP) — Shares of Cubist Pharmaceuticals Inc. rose on speculation the company may be acquired by Irish drugmaker Shire PLC.
Shire 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 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
Shire 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 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 DiseaseAugust 27, 2010 4:50 am | News | Comments
The 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.
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