Drug of last resort

Zai Lab Announces NDA for Sulbactam-Durlobactam (SUL-DUR) Granted Priority Review by China’s NMPA

Retrieved on: 
Monday, January 30, 2023
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“The CDE’s decision to grant priority review to our NDA for SUL-DUR underscores the importance of addressing the urgent need for new treatment options for patients with life-threatening infections caused by Acinetobacter species including multidrug and carbapenem-resistant strains,” said Harald Reinhart, M.D., President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases, Zai Lab.

Key Points: 
  • “The CDE’s decision to grant priority review to our NDA for SUL-DUR underscores the importance of addressing the urgent need for new treatment options for patients with life-threatening infections caused by Acinetobacter species including multidrug and carbapenem-resistant strains,” said Harald Reinhart, M.D., President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases, Zai Lab.
  • “CRAB infections are among the worst bacterial infections, and safe and effective treatment options are limited.
  • It is implemented under the Drug Registration Rules (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Tentative, NMPA 2020 No.
  • According to these guidelines, the regulatory authority will prioritize the evaluation resources for applications under priority review to help reduce review and approval timelines.

ContraFect Provides Update from the Futility Analysis of the Phase 3 DISRUPT Study of Exebacase

Retrieved on: 
Monday, December 19, 2022
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All patients in the DISRUPT study have now been independently adjudicated and the study database has been locked.

Key Points: 
  • All patients in the DISRUPT study have now been independently adjudicated and the study database has been locked.
  • The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the United States in 259 of the planned 348 patients with S. aureus bacteremia, including right-sided endocarditis.
  • Enrollment in the trial was stopped following a review of the pre-specified, interim futility analysis by the independent Data Safety Monitoring Board (DSMB).
  • The company is planning a virtual fireside chat in the first quarter of 2023 for an in-depth review and discussion of the DISRUPT study.

Invasive Aspergillosis Drug Pipeline Report 2022: Comprehensive Insights on Active Companies and Pipeline Drugs Featuring F2G, SCYNEXIS, Pulmocide, & TFF Pharmaceuticals - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 20, 2022
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This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Invasive Aspergillosis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Invasive Aspergillosis pipeline landscape.
  • The assessment part of the report embraces, in depth Invasive Aspergillosis commercial assessment and clinical assessment of the pipeline products under development.
  • This segment of the Invasive Aspergillosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • The companies and academics that are working to assess challenges and seek opportunities that could influence Invasive Aspergillosis R&D.

SCYNEXIS Announces $3 Million National Institutes of Health Grant Has Been Awarded to Case Western Reserve University Researchers to Study Second Generation Fungerp (SCY-247) to Fight Drug-Resistant Fungi

Retrieved on: 
Wednesday, November 30, 2022
Pathology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tablet, Echinocandin, Polyene, Skin, Dermatology, Mycology, Fluconazole, WHO, CDC, Auris, Infection, Food, Medical Mycology, University Hospital Medical Center at Treichville, Shanda, Icahn School of Medicine at Mount Sinai, National Institute of Allergy and Infectious Diseases, Biotechnology, Candida auris, Patient, Mortality, QIDP, Candidiasis, FLU, World Health Organization, Case Western Reserve University, University Hospitals Cleveland Medical Center, Centers for Disease Control and Prevention timeline, School, NIH, Research, Fungus, Encephalitis, Azole, IV, Drug of last resort, New Drug Application, PDUFA, FDA, Pharmaceutical industry, Vaccine

We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.

Key Points: 
  • We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.
  • C. auris has emerged in recent years as a global threat causing serious invasive infections with mortality as high as 60 percent worldwide.
  • The World Health Organization (WHO) recently released its first ever fungal priority pathogens list (FPPL), which includes C. auris in the critical priority group.
  • In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

SCYNEXIS Applauds the Biomedical Advanced Research and Development Authority (BARDA) for Its New Priority Focus on Investment in Development of Antifungal Treatments to Fight Infections Caused by Drug-Resistant Fungal Threats

Retrieved on: 
Thursday, November 17, 2022
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For the first time, BARDA announced this week it is seeking partnerships to develop broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections.

Key Points: 
  • For the first time, BARDA announced this week it is seeking partnerships to develop broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections.
  • It is extremely exciting to see BARDA announce increased emphasis on fighting dangerous fungal pathogens, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS.
  • Ibrexafungerp, with its promising activity against multiple drug resistant and often-deadly fungal infections, has enormous potential to benefit patients with severe fungal disease and limited treatment options.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

SCYNEXIS to Report Third Quarter 2022 Financial Results and Provide a Corporate Update on November 9

Retrieved on: 
Tuesday, November 1, 2022
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Conference call and webcast details:

Key Points: 
  • Conference call and webcast details:
    A live audio webcast can be accessed by visiting the Investor Relations section of the Companys website, www.scynexis.com .
  • A replay of the webcast will be archived on the SCYNEXIS website for 90 days following the event.
  • SCYNEXIS, Inc.(NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant.
  • In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

Biopharma Veteran Ivor Macleod Joins SCYNEXIS as Chief Financial Officer

Retrieved on: 
Tuesday, October 25, 2022
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JERSEY CITY, N.J., Oct. 25, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that Ivor Macleod, an accomplished biopharma industry executive, has joined the Company as Chief Financial Officer.

Key Points: 
  • JERSEY CITY, N.J., Oct. 25, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that Ivor Macleod, an accomplished biopharma industry executive, has joined the Company as Chief Financial Officer.
  • We are thrilled to welcome Ivor to the SCYNEXIS management team, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS.
  • Ivor has over 30 years of experience in the life sciences industry and has held multiple financial and operational roles, including supporting research and development, product launch, and subsequent commercialization.
  • Mr. Macleod joined SCYNEXIS from Athersys, Inc. where he served as Chief Financial Officer since January of 2020.

SCYNEXIS Presents Positive Interim Data of Oral Ibrexafungerp for Severe Fungal Infections from Ongoing Phase 3 FURI Study During IDWeek 2022

Retrieved on: 
Monday, October 24, 2022
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All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.

Key Points: 
  • All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.
  • The analyses were presented during IDWeek 2022 held in Washington, D.C., October 19-23, 2022.
  • The data presented includes 113 patients enrolled in the FURI study who had completed treatment through October 2021.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

SCYNEXIS Provides Corporate, Commercial and R&D Strategy Updates to Expand Market Potential for Its First-in-Class Antifungal

Retrieved on: 
Thursday, October 20, 2022
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During this process, SCYNEXIS will wind down its promotional activities, while keeping BREXAFEMME on the market and available to patients.

Key Points: 
  • During this process, SCYNEXIS will wind down its promotional activities, while keeping BREXAFEMME on the market and available to patients.
  • SCYNEXIS will conclude the partnership with its contracted commercial sales partner, Amplity Health, and will undertake a workforce reduction.
  • SCYNEXIS is announcing changes to its executive leadership team:
    Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, will retire as of December 31, 2022.
  • During this process, SCYNEXIS will wind down its promotional activities, while keeping BREXAFEMME on the market and available to patients.

Peptilogics to Present Data at IDWeek 2022 on PLG0206, an Engineered Antimicrobial Peptide Targeting Bacteria Causing Periprosthetic Joint Infection

Retrieved on: 
Thursday, October 20, 2022
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Peptilogics, a clinical stage biotech company engineering peptide therapeutic solutions for patients with life-threatening diseases, is presenting two posters featuring preclinical data from its antimicrobial peptide, PLG0206, at IDWeek 2022 .

Key Points: 
  • Peptilogics, a clinical stage biotech company engineering peptide therapeutic solutions for patients with life-threatening diseases, is presenting two posters featuring preclinical data from its antimicrobial peptide, PLG0206, at IDWeek 2022 .
  • The studies demonstrate the potent activity of PLG0206 against bacteria that cause periprosthetic joint infections (PJI), including multidrug resistant (MDR) bacteria.
  • PJI is the most common complication of joint replacement surgery and is a life-changing event for patients.
  • MDR related infections pose a significant concern to patients as well as society in both the short- and long-term.