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Pharmaceuticals

Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients

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— High Cure Rates Observed with Single Tablet Regimen May Eliminate Interferon and Ribavirin from HCV Therapy for Genotype 1 Patients — — U.S. NDA Submission Planned for Q1 2014– FOSTER CITY, Calif.–(BUSINESS WIRE)–Dec. 18, 2013– Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from three Phase 3 clinical trials (ION-1, ION-2 and ION-3) evaluating the […]

Regeneron Announces FDA Acceptance of EYLEA® (aflibercept) Injection Supplemental Biologics License Application for Review for Diabetic Macular Edema Indication

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TARRYTOWN, N.Y., Dec. 18, 2013 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company’s supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA […]

Circuit Therapeutics and Boehringer Ingelheim announce signature of a research partnership agreement to discover new approaches to treating psychiatric disorders

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Menlo Park, California and INGELHEIM, Germany, 18 December, 2013 – Boehringer Ingelheim and Circuit Therapeutics have entered into a research collaboration agreement for the discovery of new ways of treating psychiatric disorders. Circuit Therapeutics provides an innovative platform that allows the identification and characterization of drug targets from brain circuits involved in normal and pathological behaviors. […]

Mylan Announces Acquisition of Rights to Novel LAMA Respiratory Compound from Pfizer

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PITTSBURGH, Dec. 18, 2013 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that it has received all regulatory approvals and has completed an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize a novel long-acting muscarinic antagonist (LAMA) compound for various indications. Mylan expects that this product, which is ready to […]

A Space Age View into Human Vision: Abbott’s iDesign Dx System Now Available for U.S. Ophthalmologists and Patients

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Captures Five Optical Measurements in One High-Resolution Scan; Same Wavefront Sensing Technology Used to Measure NASA’s James Webb Space Telescope’s Optics December 17, 2013 — Abbott Park, Illinois (NYSE: ABT) — With the introduction of Abbott’s iDesign Dx system, U.S. ophthalmologists now have a diagnostic tool that can capture five optical measurements in one three-second […]

Biogen Idec and Samsung Bioepis Announce Agreement to Market Anti-TNF Biosimilar Product Candidates in Europe

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– Biogen Idec Opts-In to Commercialization Opportunity with Joint Venture Partner – CAMBRIDGE, Mass. & SEOUL, Korea–(December 17, 2013)–Biogen Idec (NASDAQ: BIIB) and Samsung Bioepis today announced that through their joint venture, Biogen Idec has exercised its right to enter into an agreement to commercialize anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to […]

Mylan Announces Settlement Agreement for First-to-File Generic Version of TARGRETIN®

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Agreement includes a no-later-than July 9, 2015 launch PITTSBURGH, Dec. 17, 2013 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l that will […]

Health Canada Issues Notice of Compliance for Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C

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– Sovaldi Receives Marketing Authorization for Patients with Genotypes 1, 2, 3 or 4 HCV – – High Cure Rates (SVR 12) and Therapy Shortened to Just 12 Weeks for Many Patients – FOSTER CITY, Calif.–(BUSINESS WIRE)–Dec. 16, 2013– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has issued a Notice of Compliance for Sovaldi™ (sofosbuvir) 400 […]

Varian Imaging Components President Robert Kluge Announces Plans to Retire; Varian CEO Dow Wilson Names Sunny Sanyal as Kluge’s Successor

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PALO ALTO, Calif., Dec. 16, 2013 /PRNewswire/ — Varian Medical Systems (NYSE:VAR) today announced that Robert H. Kluge has announced his intention to retire as its Senior Vice President and President, Imaging Components Businesses effective February 7, 2014.  Varian CEO Dow R. Wilson has named and the Board of Directors has appointed Sunny Sanyal, CEO of T-System, to succeed Kluge.  Varian’s Imaging Components Businesses […]

Valeant Pharmaceuticals Agrees to Acquire Solta Medical for $2.92 Per Share in Cash

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Combination Creates a Global Leader in Aesthetics Transaction Values Solta at Approximately $250 Million Transaction Expected to Close in the First Quarter of 2014 LAVAL, Quebec and HAYWARD, Calif., Dec. 16, 2013 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that it has entered into a definitive agreement under which […]

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