Ensitrelvir

Advancing Healthcare Innovation: Juniper Biologics Recognized as the Best Novel Therapy R&D and Commercialization Company 2024 by APAC Insider

Retrieved on: 
Monday, March 25, 2024
Culture, Growth, COVID-19, Patient, Oncology, Quality of life, Investment, Ensitrelvir, Therapy, Health, Pharmaceutical industry

SINGAPORE, March 25, 2024 /PRNewswire/ -- Juniper Biologics ("Juniper"), Singapore-based science-led pharmaceutical company focused on researching, developing, and commercializing novel therapies, celebrates another milestone as it received the award for Best Novel Therapy R&D and Commercialization Company at the APAC Insider Singapore Business Awards 2024.

Key Points: 
  • SINGAPORE, March 25, 2024 /PRNewswire/ -- Juniper Biologics ("Juniper"), Singapore-based science-led pharmaceutical company focused on researching, developing, and commercializing novel therapies, celebrates another milestone as it received the award for Best Novel Therapy R&D and Commercialization Company at the APAC Insider Singapore Business Awards 2024.
  • The APAC Insider Singapore Business Awards serves to spotlight companies and entrepreneurs driving growth in the region's business market and strengthening the country's open economy.
  • Amidst Singapore's dynamic business landscape, home to various startups and enterprises across industries, Juniper has become a standout presence.
  • "We are deeply honored to receive this prestigious business award," expressed Raman Singh, Founder and Chief Executive Officer of Juniper Biologics.

Advancing Healthcare Innovation: Juniper Biologics Recognized as the Best Novel Therapy R&D and Commercialization Company 2024 by APAC Insider

Retrieved on: 
Monday, March 25, 2024
Culture, Growth, COVID-19, Patient, Oncology, Quality of life, Investment, Ensitrelvir, Therapy, Health, Pharmaceutical industry

SINGAPORE, March 24, 2024 /PRNewswire/ -- Juniper Biologics ("Juniper"), Singapore-based science-led pharmaceutical company focused on researching, developing, and commercializing novel therapies, celebrates another milestone as it received the award for Best Novel Therapy R&D and Commercialization Company at the APAC Insider Singapore Business Awards 2024.

Key Points: 
  • SINGAPORE, March 24, 2024 /PRNewswire/ -- Juniper Biologics ("Juniper"), Singapore-based science-led pharmaceutical company focused on researching, developing, and commercializing novel therapies, celebrates another milestone as it received the award for Best Novel Therapy R&D and Commercialization Company at the APAC Insider Singapore Business Awards 2024.
  • The APAC Insider Singapore Business Awards serves to spotlight companies and entrepreneurs driving growth in the region's business market and strengthening the country's open economy.
  • Amidst Singapore's dynamic business landscape, home to various startups and enterprises across industries, Juniper has become a standout presence.
  • "We are deeply honored to receive this prestigious business award," expressed Raman Singh, Founder and Chief Executive Officer of Juniper Biologics.

Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open

Retrieved on: 
Friday, February 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, RNA, Ministry, Fast Track, Food, Conference, Ensitrelvir, Drug development, JAMA Network Open, Opportunism, Cough, Senior, Head, Fungal infection, Patient, Risk, Generic, Pharmaceutical industry

The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • “We’re pleased to present the data from our Phase 3 study conducted in Asia in this peer-reviewed article.
  • These results demonstrate accelerated resolution in a range of symptoms, reinforcing the potential of ensitrelvir across multiple patient profiles.
  • Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies.

Shionogi Presents New Ensitrelvir COVID-19 Data Supporting Effectiveness in Real-World and Clinical Settings at IDWeek 2023

Retrieved on: 
Wednesday, October 11, 2023
COVID-19, Research, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Senior, Food, Sense, Ensitrelvir, Inc., Taste, Safety, Dysgeusia, MHLW, Drug development, Ministry of Health, Labour and Welfare, Ministry, Head, Fever, Fast Track, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Shionogi, Patient, Risk, Pharmaceutical industry

Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will present new real-world and clinical data at IDWeek 2023 reinforcing the potential of ensitrelvir, its investigational oral antiviral, to treat the symptoms of COVID-19.

Key Points: 
  • Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will present new real-world and clinical data at IDWeek 2023 reinforcing the potential of ensitrelvir, its investigational oral antiviral, to treat the symptoms of COVID-19.
  • Shionogi will present new data evaluating the effectiveness and tolerability of ensitrelvir in clinical practice in Japan.
  • Following emergency regulatory approval from the MHLW in Japan, an ongoing post-marketing surveillance study is enrolling 3,000 Japanese patients.
  • As of July 20, 2023, a total of 1,682 patients were enrolled, of which, 1,589 were evaluated for safety and 1,584 for effectiveness.

Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023

Retrieved on: 
Monday, September 18, 2023
Health, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, European Scientific Cooperative on Phytotherapy, Influenza, Medical Affairs Bureau, MHLW, SARS-CoV-2, Head, Kidney, Ministry of Health, Labour and Welfare, Fast Track, Research, COVID, Ministry, Ensitrelvir, Patient, Risk, Hearing, Ministry of Health (Saudi Arabia), BMI, Regulation of tobacco by the U.S. Food and Drug Administration, Conference, Cancer, Food, Kidney disease, Pharmaceutical industry, Vaccine, Shionogi

Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

Key Points: 
  • Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
  • Known as Xocova® in Japan, ensitrelvir received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection in November 2022.
  • In April 2023, ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration.
  • “These results indicate the potential for ensitrelvir to help address these needs.”

IDWeek 2023: Shionogi and Qpex Biopharma, Inc. Continue Longstanding Commitment to Addressing Unmet Needs in Infectious Disease

Retrieved on: 
Thursday, September 7, 2023
Health, Infectious Diseases, COVID-19, Research, Science, Pharmaceutical, Biotechnology, Abstract, Inc., Doctor of Pharmacy, Senior, SARS-CoV-2, Infection, Safety, Hospital, Head, Achromobacter, Stenotrophomonas maltophilia, Part, Non, Pseudomonas aeruginosa, Acquisition, Centre for Industry Education Collaboration, DTR, Learning, Effectiveness, Site, Patient, Sense, Randomized controlled trial, Generic, SENTRY, Treatment, Interim analysis, Pharmaceutical industry, Shionogi, Ensitrelvir

: S-217622, hereafter “ensitrelvir”), and Fetroja® (cefiderocol), an antibiotic marketed under the brand name Fetcroja® in Europe.

Key Points: 
  • : S-217622, hereafter “ensitrelvir”), and Fetroja® (cefiderocol), an antibiotic marketed under the brand name Fetcroja® in Europe.
  • Shionogi recently extended its infectious disease innovation platform with the acquisition of Qpex Biopharma Inc. (Qpex) in July.
  • The acquisition brings a novel investigational ß-lactamase inhibitor to Shionogi, expanding the company’s pipeline of critically needed antimicrobials, and further augmenting its R&D capabilities and expertise.
  • During IDWeek, Shionogi will host a Learning Lounge with David Nicolau, PharmD, titled Fetroja® (cefiderocol), An Overview of In Vitro and Clinical Data on Friday, October 13, from 10:15 – 11:00 AM ET.

Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Retrieved on: 
Friday, June 9, 2023
Science, Research, General Health, Health, FDA, COVID-19, Infectious Diseases, Clinical Trials, Infection, Therapy, MHLW, SARS-CoV-2, Head, Public, Respiratory disease, Ministry of Health, Labour and Welfare, Fast Track, Ministry, Ensitrelvir, Patient, Ministry of Health (British Columbia), Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Shionogi

The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • : S-217622, hereafter “ensitrelvir”) for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2, when compared to placebo.
  • In addition, Shionogi also announced that it has filed for full approval of ensitrelvir in Japan.
  • Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

ECCMID 2023: Shionogi to Present Data Showing COVID-19 Symptom Recurrence is Not Associated with Ensitrelvir Treatment

Retrieved on: 
Tuesday, April 4, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, MHLW, SARS-CoV-2, Head, Ministry of Health, Labour and Welfare, Fast Track, Infection, RNA, Ministry, Ensitrelvir, Congress, ECCMID, Patient, European, Ministry of Health (Saudi Arabia), FDA, Recurrence, Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PCR, Food, Pharmaceutical industry, Vaccine, Shionogi

: S-217622, hereafter “ensitrelvir”) will be published as posters at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark 15 - 18 April 2023.

Key Points: 
  • : S-217622, hereafter “ensitrelvir”) will be published as posters at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark 15 - 18 April 2023.
  • Ensitrelvir, known as Xocova® 125 mg tablet in Japan, received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection.
  • The first late-breaking poster presentation included a post-hoc analysis of the Phase 3 part showing that viral rebound and symptom recurrence were infrequently seen up to 21 days after treatment with ensitrelvir.
  • Symptom recurrence was rare and was not associated with viral RNA rebound.

Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19

Retrieved on: 
Tuesday, April 4, 2023
Health, FDA, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Therapy, MHLW, SARS-CoV-2, Head, Infection, Ministry of Health, Labour and Welfare, Fast Track, Research, Fungal infection, Medicines Patent Pool, Ministry, Ensitrelvir, CROI, Patient, Ministry of Health (Saudi Arabia), Developing country, Diagnosis, United, Generic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Food, Safety, Pharmaceutical industry, Shionogi

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need.
  • Receiving Fast Track designation from the FDA recognizes the potential of ensitrelvir as a once-daily, oral antiviral for SARS-CoV-2,” said Nathan McCutcheon, CEO, Shionogi Inc., the U.S. subsidiary of Shionogi.
  • Several additional Phase 3 clinical studies evaluating the safety and efficacy of ensitrelvir across a wide range of COVID-19 patient populations are planned and ongoing.

Arbutus Presents AB-343 Data at the 36th International Conference on Antiviral Research

Retrieved on: 
Tuesday, March 14, 2023
Poster, Conference, Ensitrelvir, Enzyme assay, Viral, Novel, Pan, SARS-CoV-2, Arbutus, International Conference on Emerging Infectious Diseases, Gesellschaft mit beschränkter Haftung, ICAR, Dodi Protero, Virology, Antiviral Research, EC50, Omicron, Therapy, IND, Pharmaceutical industry, Vaccine, Mpro

WARMINSTER, Pa., March 14, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that preclinical data for AB-343, our novel oral SARS-CoV-2 Mpro inhibitor, has been presented in poster format at the 36th International Conference on Antiviral Research (ICAR), in Lyon, France.

Key Points: 
  • “We are excited that our preclinical data for AB-343 has been selected for poster presentation at ICAR.
  • Many of the studies compared AB-343 to nirmatrelvir, the active ingredient in Pfizer’s Paxlovid™ and ensitrelvir, the active ingredient in Shionogi’s Xocova®.
  • The results showed that AB-343 targets SARS-CoV-2 Mpro and inhibits viral replication in vitro (EC50 ~ 20nM).
  • Some of these studies were conducted in part with Proteros biostructures GmbH under the discovery research and license agreement entered into in April 2021.