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Feb. 24, 2020
Shionogi’s FETROJA® (cefiderocol) Now Available for the Treatment of Complicated Urinary Tract Infections in the U.S.
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced FETROJA® (cefiderocol) is now available in the U.S. for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis,…
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Nov. 15, 2019
FETROJA® (cefiderocol) Approved by the FDA for Treatment of Complicated Urinary Tract Infections (cUTI) in Adult Patients with Limited or No Alternative Treatment Options
FETROJA is the first approved antibiotic that functions as a siderophore FETROJA binds to free iron to gain additional cell entry FETROJA demonstrated higher response rates versus imipenem/cilastatin in a cUTI study OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced the U.S. Food and Drug Administration (FDA) has approved…
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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 options.…
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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 OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP). Results from…
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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 – OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced that the company will deliver 20 data presentations for Shionogi compounds, including a late-breaker oral presentation of cefiderocol Phase III APEKS-NP trial results, at IDWeek™, October 2-6, 2019, in…
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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)–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 transfer of rights is effective immediately.…
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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)–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 data presentations taking place at the European Congress of…
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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…
