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Oct. 16, 2019
U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)– Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment…
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Oct. 2, 2019
Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens
APEKS-NP trial met primary endpoint of non-inferiority of cefiderocol compared to meropenem
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Sep. 26, 2019
Shionogi to Present New Data at IDWeek 2019
– Including Cefiderocol Phase III APEKS-NP Trial as Late-breaker Oral Presentation –
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Jun. 17, 2019
Shionogi to Present Cefiderocol and COT-143 Data at American Society for Microbiology Microbe 2019 Meeting
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced there will be one oral presentation and 17 poster presentations featuring two of the company’s investigational compounds at the American Society for Microbiology (ASM) Microbe meeting, being held June 20–24, 2019 in San Francisco. Sixteen…
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Apr. 10, 2019
Shionogi Announces Licensing of Symproic® (naldemedine) to BioDelivery Sciences International Inc.
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi Inc. (hereafter “Shionogi”) announced today that BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain, has licensed full rights to commercialize Symproic® (naldemedine) tablets 0.2 mg in the United States. The…
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Apr. 4, 2019
Shionogi to Present New Data at European Congress of Clinical Microbiology and Infectious Diseases 2019
OSAKA, Japan & AMSTERDAM, Netherlands & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & AMSTERDAM, Netherlands & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.) and Shionogi B.V. and Shionogi Inc., the European and the U.S. subsidiaries of Shionogi & Co., Ltd respectively, (hereafter “Shionogi”) today announced 12…
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Shionogi to Present Clinical Data on Lusutrombopag at the International Liver Congress™ 2019 of the European Association for the Study of the Liver (EASL)
OSAKA, Japan & AMSTERDAM–(BUSINESS WIRE)–Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter “Shionogi”), announced it will present four posters on lusutrombopag, a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, at The International Liver Congress™, the annual meeting of the European Association for the Study of the Liver (EASL), to be…
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Mar. 6, 2019
FDA Accepts XOFLUZA™ (Baloxavir Marboxil) Supplemental New Drug Application for the Treatment of Influenza in Individuals at High Risk for Influenza-Related Complications
OSAKA, Japan, March 6, 2019 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for XOFLUZA™ (baloxavir marboxil) for the treatment of influenza in individuals at high-risk for influenza-related…
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Nov. 7, 2018
Shionogi to Present Clinical Data on Mulpleta® (lusutrombopag) at the Liver Meeting® 2018 of the American Association for the Study of Liver Diseases (AASLD)
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) announced it will present four posters on Mulpleta® (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, at The Liver Meeting®, the premiere annual meeting in the science and practice of hepatology from the American…
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Oct. 25, 2018
Pivotal Trial Results for Shionogi’s Cefiderocol Published in the Lancet Infectious Diseases
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) announced today that The Lancet Infectious Diseases journal has published clinical results from the pivotal randomized controlled trial evaluating cefiderocol for the treatment of complicated urinary tract infection (cUTI) in patients at risk of multidrug-resistant Gram-negative infections.…
