QIDP

Microbion Corporation Announces Poster Highlighting Pravibismane Activity Against Common Cystic Fibrosis Pulmonary Pathogens to be Presented at the North American Cystic Fibrosis Conference 2022

Retrieved on: 
Thursday, November 3, 2022
Doctor of Philosophy, Company, NTM, Mycobacterium abscessus, Growth, Cystic Fibrosis Foundation, Cystic fibrosis, Multimedia, Infection, Wellcome Trust, CF, Federal Ministry of Health (Germany), Mycobacterium, FDA, Investor, Safety, Seattle Children's, Department, Conference, Poster, Education, QIDP, Staphylococcus aureus, Orphan drug, Intention, Respiratory tract, Stenotrophomonas maltophilia, Hospital, Burkholderia cepacia complex, US, ATP, Pseudomonas aeruginosa, Assistant, Degenerative disease, Cooperative, Chronic lung disease, Urinary tract infection, NIH, Federal Ministry of Education and Research (Germany), Patient, MD, Acinetobacter baumannii, United States Department of Defense, Pharmaceutical industry, BC, Research

BOZEMAN, MT and VANCOUVER, BC, Nov. 3, 2022 /PRNewswire/ - Microbion Corporation today announced that the company will present a poster at the North American Cystic Fibrosis Conference, November 3 5, in Philadelphia, PA highlighting the activity of pravibismane against bacterial pathogens associated with lung infection in people with cystic fibrosis (CF).

Key Points: 
  • BOZEMAN, MT and VANCOUVER, BC, Nov. 3, 2022 /PRNewswire/ - Microbion Corporation today announced that the company will present a poster at the North American Cystic Fibrosis Conference, November 3 5, in Philadelphia, PA highlighting the activity of pravibismane against bacterial pathogens associated with lung infection in people with cystic fibrosis (CF).
  • Title:Investigating the activity of pravibismane against bacterial isolates common in cystic fibrosis pulmonary infections (Poster No.
  • The presence of pulmonary surfactant did not have an impact on pravibismane activity.
  • Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants.

CorMedix Inc. to Report Third Quarter 2022 Financial Results and Provide a Corporate Update on November 10

Retrieved on: 
Wednesday, November 2, 2022
Marketing, CMO, New chemical entity, Endpoint security, Trial of the century, Technology, NDA, Cancer, Company, FDA, Patient, Fast Track, Heparin, QIDP, New Drug Application, CRL, Pharmaceutical industry

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases.

Key Points: 
  • CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.
  • The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.
  • Neutrolin is CE Marked and has been marketed in Europe and other territories as a medical device.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022 Conference Call and Provide Business Update

Retrieved on: 
Tuesday, November 1, 2022
Security (finance), Marketing, MRSA, Clostridioides, DNA, Infection, IIIC, Clostridioides difficile (bacteria), Securities and Exchange Commission (Philippines), Annual report, Methicillin-resistant Staphylococcus aureus, Gram, VRE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, CDI, Maintenance, GAIN, Private Securities Litigation Reform Act, Company, Clostridioides difficile infection, FDA, Enterococcus, Patient, Food, Fast Track, QIDP, CDC, Act, Firmicutes, GPSS, DRSP, Pharmaceutical industry, Actinobacteria

It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

Biopharma Veteran Ivor Macleod Joins SCYNEXIS as Chief Financial Officer

Retrieved on: 
Tuesday, October 25, 2022
Shanda, PDUFA, Merck, American, Vagina, IA, General manager, Merck & Co., New Drug Application, Indian stock exchange, Employment, QIDP, Infection, Candidiasis, NASDAQ, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biotechnology, Patient, IV, IC, Research, Nasdaq, Interim management, Food, Company, Industry, Fungemia, RSU, GLOBE, Interim, Eisai, FDA, Drug of last resort, Tablet, Pharmaceutical industry

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.

F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim

Retrieved on: 
Friday, October 21, 2022
News, European Medicines Agency, Nausea, Aspergillosis, SOC, Infection, US Foods, QIDP, Mycosis, Diarrhea, Patient, Fungus, Hematology, Standard of care, Hepatotoxicity, Mortality, Coccidioidomycosis, BID, Food, Scedosporiosis, ACM, Vomiting, DHODH, Food and Drug Administration, MD, Doctor of Philosophy, Immunosuppression, Safety, CNS, GLOBE, Goodyear F2G Corsair, Central nervous system, Antifungal, FDA, Breakthrough therapy, UZ Leuven, Pharmaceutical industry, Scopulariopsis, Overalls, Coccidioides, Aspergillus, Scedosporium

Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.

Key Points: 
  • Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.
  • Data came from 100 patients with proven invasive fungal infection or probable pulmonary invasive aspergillosis (IA).
  • Mortality remains unacceptably high in patients with severe and life-threatening fungal infections being treated with currently available therapies.
  • Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

PolyPid Announces Cost Reduction Plan

Retrieved on: 
Thursday, October 20, 2022
PLEX, API, Marketing, Infection, Colorectal surgery, SSIS, QIDP, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Technology, Private Securities Litigation Reform Act, Food, Company, Abdomen, Active ingredient, Intention, Nature, GLOBE, Forward-looking statement, Glioblastoma, FDA, Breakthrough therapy, Polypide, Pharmaceutical industry, EU

PETACH TIKVA, Israel, Oct. 20, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a cost reduction plan, including a 20% reduction in headcount across all departments as the Company prepares for planned discussions in the first quarter of 2023 with the U.S. Food and Drug Administration (FDA) and EU regulatory authorities regarding the regulatory pathway for D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. PolyPid expects that these actions will extend the Company’s cash runway into the third quarter of 2023.

Key Points: 
  • PolyPid expects that these actions will extend the Companys cash runway into the third quarter of 2023.
  • PolyPid will provide further details on its regulatory plans and cash position on its third quarter 2022 financial results and corporate update call on November 9, 2022.
  • D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
  • PolyPid Ltd. (Nasdaq: PYPD ) is a late-stage biopharma company aiming to improve surgical outcomes.

CorMedix Inc. Announces Abstract Presentation at Upcoming American Society of Nephrology Conference

Retrieved on: 
Thursday, October 20, 2022
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The abstract being presented highlights a retrospective analysis that was conducted integrating multiple clinical and claims databases that track kidney failure patients.

Key Points: 
  • The abstract being presented highlights a retrospective analysis that was conducted integrating multiple clinical and claims databases that track kidney failure patients.
  • CorMedix has demonstrated in a Phase 3 clinical study that DefenCath can reduce the incidence of CRBSIs in CVC patients undergoing hemodialysis by approximately 71%.
  • The abstract is included below and available through the American Society of Nephrology conference website.
  • CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
Thursday, October 20, 2022
CRL, U.S. Securities and Exchange Commission, SPA, Urinary tract infection, SEC, Therapy, Woman, Hand, Infection, QIDP, Amoxicillin/clavulanic acid, NDA, Probenecid, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Penem, IV, Renewable Energy and Energy Efficiency Partnership, Security (finance), UTI, Nasdaq, Food, Legislation, Adult, Safety, Bacteria, Phrase, ITRM, GLOBE, Medical microbiology, Clinical trial, Forward-looking statement, Public policy, FDA, COVID-19, Pharmaceutical industry, Vaccine

DUBLIN, Ireland and CHICAGO, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company developing antibiotics to treat infections caused by multi-drug resistant pathogens, today announced that the first patient has been dosed in its Phase 3 clinical trial, known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE), comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • With positive results, we would resubmit our new drug application (NDA) to the FDA in the second half of 2024.
  • The REASSURE trial is designed as a non-inferiority trial comparing oral sulopenem and Augmentin in the Augmentin susceptible population and is entitled A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.
  • Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin twice daily for 5 days.
  • The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the trial.

Iterum Therapeutics to Present Data at IDWeek 2022

Retrieved on: 
Monday, October 17, 2022
Therapy, Infection, QIDP, Poster, Walter E. Washington Convention Center, Penem, IV, Nasdaq, Company, Walter, Bacteria, Infectious Diseases Society of America, ITRM, GLOBE, Washington Convention Center, Pharmaceutical industry

The hybrid conference will be held from October 19-23 at the Walter E. Washington Convention Center in Washington, D.C.

Key Points: 
  • The hybrid conference will be held from October 19-23 at the Walter E. Washington Convention Center in Washington, D.C.
  • Posters will be available for registrants on the IDWeek Interactive Program and the IDWeek Mobile App starting on October 19, 8 a.m.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.