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Monthly Archives: January 2017

FDA Grants Breakthrough Therapy Designation to uniQure’s Investigational Hemophilia B Drug

LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Jan. 30, 2017 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced that AMT-060,  its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  This designation …

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Celgene to Acquire Autoimmune Disease Startup Delinia

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) and Delinia, Inc. (“Delinia”), a privately held biotechnology company developing novel therapeutics for autoimmune diseases, today announced that they have entered into an agreement for the acquisition of Delinia by Celgene. The transaction expands Celgene’s Inflammation and Immunology pipeline through …

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Pembrolizumab Active Against Mucosal Melanoma Tumors and Prolongs Survival for Bladder Cancer Patients

Amsterdam, The Netherlands: Clinical trials of a new immunotherapy, pembrolizumab, have shown that it prolongs life significantly for patients with bladder cancer and is active against a rare sub-type of melanoma, called mucosal melanoma. The findings were presented in two presentations at the European Cancer Congress 2017 [1] today. Until …

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Regulus Therapeutics Announces Continuation of FDA Clinical Hold on RG-101

LA JOLLA, Calif., Jan. 27, 2017 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for RG-101 remains on …

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Ferring and Enteris BioPharma to Co-Develop an Oral Formulation of a Peptide-Based Injectable Therapeutic

SAINT-PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals and Enteris BioPharma, Inc. announced today that the companies have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence™, to engineer an oral formulation of a peptide-based injectable therapeutic developed …

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Incyte and Calithera Collaborate for Development of Clinical-Stage Arginase Inhibitor

WILMINGTON, Del. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Incyte Corporation (NASDAQ:INCY) and Calithera Biosciences, Inc. (NASDAQ:CALA) announce today that the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently …

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Johnson & Johnson to Acquire Actelion in $30 Billion Deal

NEW BRUNSWICK, N.J. and ALLSCHWIL and BASEL, Switzerland, Jan. 26, 2017 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) and Actelion Ltd. (SIX:ATLN) today announced that they have entered into a definitive transaction agreement under which Johnson & Johnson will launch an all-cash tender offer in Switzerland to acquire all of …

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FDA Grants Orphan Drug Designation to TG Therapeutics’ Investigational DLBCL Candidate

NEW YORK, Jan. 24, 2017 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment …

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Researchers Discover Potential New Target for Treating Glioblastoma

DALLAS – January 24, 2017 – Scientists have found a way to inhibit the growth of glioblastoma, a type of brain cancer with low survival rates, by targeting a protein that drives growth of brain tumors, according to research from the Peter O’Donnell Jr. Brain Institute and Harold C. Simmons …

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HCV: Relapse or Reinfection?

Today’s hepatitis C medications offer extremely high cure rates. In fact, the few cases of a previously treated patient later testing positive for hepatitis C has some patients wondering “did I relapse or could I have been reinfected?” There are six different genotypes of the hepatitis C virus (as well …

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