Melinta Therapeutics

Cidara Therapeutics Announces Divestiture of Rezafungin to Mundipharma* to Focus on Advancing the Clinical Development of Cloudbreak DFC Pipeline

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星期三, 四月 24, 2024
Melinta Therapeutics, Sale, Tavarua, Health care, IND, Disease, CDTX, Patent, Patient, CMC, Asset, Intellectual property, DFC, Therapy, SAN, Respect, Pharmaceutical industry

Mundipharma currently has commercial rights to rezafungin outside the U.S. and Japan.

Key Points: 
  • Mundipharma currently has commercial rights to rezafungin outside the U.S. and Japan.
  • Mundipharma purchased the assets in consideration of its assumption of the ongoing obligation to conduct and fund the ReSPECT Phase 3 clinical trial, the costs of the rezafungin patent portfolio and CMC and regulatory obligations.
  • The purchased assets also include all rezafungin intellectual property rights, product data, regulatory approvals, rezafungin product and comparator inventory, specified prepaid assets and specified contracts.
  • *Assets and rights acquired by Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies.

BiomX Announces the Appointment of Susan Blum to its Board of Directors

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星期四, 四月 18, 2024
Melinta Therapeutics, NESS, CFO, PDL, Orbitz, IPO, PDL BioPharma, Santa Clara University, Commerce, Therapy, Ernst & Young, Certified Public Accountant, Management

and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors.

Key Points: 
  • and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors.
  • Ms. Blum was also appointed to serve as a member and chair of the audit committee of the Board.
  • Prior to joining Melinta, Ms. Blum served as Corporate Controller at Textura Corporation from 2013 to 2016, supporting the company’s IPO and transformation into a publicly-traded organization.
  • Ms. Blum is a Certified Public Accountant, currently serves as a member of the BioNJ Cybersecurity Committee and holds a B.S.

Mundipharma acquires all assets and rights related to REZZAYO® (rezafungin), reinforcing continued commitment to management of infectious diseases and specialty care therapeutic area

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星期三, 四月 24, 2024
Infectious Diseases, Biotechnology, Pharmaceutical, Health, FDA, Melinta Therapeutics, Commercialization, Mortality, Food, European Commission, Patient, Acquisition, Medicine, Civil service commission, MHRA, Immune system, Therapy, Disease

Mundipharma* today announced the acquisition of all assets and rights related to rezafungin globally from Cidara Therapeutics.

Key Points: 
  • Mundipharma* today announced the acquisition of all assets and rights related to rezafungin globally from Cidara Therapeutics.
  • This provides Mundipharma with global ownership of rezafungin including ongoing development and distribution.
  • Rezafungin received approval by the U.S. Food and Drug Administration (FDA) in March 20239 and the European Commission (EC) in December 202310.
  • *Assets and rights acquired by Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies.

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

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星期五, 二月 23, 2024
Research, Infectious Diseases, FDA, Hospitals, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Urinary tract infection, CRL, New Drug Application, Multimedia, Chemistry, Food, Pyelonephritis, Symantec Endpoint Protection, Patient, Medicine, Melinta Therapeutics, Medication, NDA, CMC, Pharmaceutical industry

This press release features multimedia.

Key Points: 
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240223169844/en/
    The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
  • “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.

New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection

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星期二, 二月 20, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Hospitals, Clinical Trials, Senior, Urinary tract infection, Infection, Multimedia, MDR, MD, Physician, Marketing, Antimalarial medication, Klebsiella pneumoniae, Pyelonephritis, NEJM, Safety, Therapy, Patient, UTI, AP, Melinta Therapeutics, Medication, Pseudomonas aeruginosa, Fungal infection, Pharmaceutical industry

Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.

Key Points: 
  • Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.
  • The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240220917017/en/
    “Gram-negative infections such as cUTI have become increasingly difficult to treat due to acquired bacterial resistance to multiple classes of antibiotics.

Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China

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星期三, 十二月 6, 2023
Food, Caspofungin, Biotechnology, Melinta Therapeutics, EMA, Burn, European, SAN, Therapy, CDTX, European Medicines Agency, MPH, Patient, Safety, Food and Drug Administration, Fungemia, CHMP, Pharmaceutical industry

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

Key Points: 
  • The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis.
  • ReSTORE ( NCT03667690 ) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis.
  • “The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara.
  • Melinta Therapeutics has the exclusive commercialization rights to REZZAYOTM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.

Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

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星期二, 十二月 5, 2023
Other Health, Research, Managed Care, Pharmaceutical, Hospitals, Clinical Trials, Science, Surgery, Biotechnology, FDA, Other Science, Health, CDTX, Lancet, NDA, Priority review, Disease, Safety, Food, Melinta Therapeutics, European Medicines Agency, Therapy, NTAP, Injection, Randomized controlled trial, QIDP, The Lancet, MAA, Mortality, Restore, EMA, Patient, Caspofungin, CHMP, Marketing, Advanced Therapy Medicinal Product, New Drug Application, CMS, MPH, Medicare, Hospital, Pharmaceutical industry, MD, Fungemia

These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.

Key Points: 
  • These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.
  • On March 22, 2023, the FDA approved REZZAYO for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
  • REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over fifteen years.
  • In October, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.

Privo Technologies, Inc. Appoints Dr. Albert Collinson as Independent Non-Executive Director

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星期四, 十一月 9, 2023
Biotechnology, Health, ImmunoGen, Therapy, Melinta Therapeutics, Drug discovery, Pharmacy, Patient, Management, Pharmaceutical industry

PEABODY, Mass., Nov. 9, 2023 /PRNewswire/ -- Privo Technologies Inc. is pleased to announce the appointment of Dr. Albert Collinson as an Independent Non-Executive Director to its esteemed Board of Directors.

Key Points: 
  • PEABODY, Mass., Nov. 9, 2023 /PRNewswire/ -- Privo Technologies Inc. is pleased to announce the appointment of Dr. Albert Collinson as an Independent Non-Executive Director to its esteemed Board of Directors.
  • Dr. Collinson, a distinguished industry expert and former Business Development Advisor to Privo Technologies, brings a wealth of experience and expertise to his new role.
  • Dr. Collinson has over 35 years of experience in the pharmaceutical and biotechnology industries.
  • Dr. Collinson expressed his enthusiasm about his new role, stating, "I am honored to join Privo Technologies Inc. as an Independent Non-Executive Director.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

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星期四, 十一月 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

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星期四, 十一月 2, 2023
Research, Medicare, Influenza, Treatment, European Directive on Traditional Herbal Medicinal Products, New Drug Application, Centers for Medicare & Medicaid Services, Fungal infection, Translation, DFC, CHMP, Committee for Medicinal Products for Human Use, CDTX, European Medicines Agency, Invasive candidiasis, EMA, Safety, CD73, Therapy, Patient, European Commission, ATM, Respect, Committee, Conference, NTAP, New Shrimadhopur DFC Station, Janssen Pharmaceuticals, Tavarua, FDA, IND, EC, Senior, Johnson & Johnson, CMS, SAN, Pharmaceutical industry, Vaccine, Cryptocurrency, Security (finance), Janssen, Mundipharma, Melinta Therapeutics

Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.

Key Points: 
  • Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.
  • Presented at IDWeek 2023: In September 2023, Cidara delivered an oral presentation and two poster presentations highlighting the safety and efficacy of CD388.
  • For the nine months ended September 30, 2023 and 2022, net loss was $17.3 million and $16.4 million, respectively.
  • During the three months ended September 30, 2023, Cidara did not sell shares of common stock pursuant to its at-the-market (ATM) sales agreement.