Daptomycin

ContraFect Announces Publication on Exebacase and CF-296 Demonstrating Potent In Vivo Antimicrobial Activity in Implant-Associated MRSA Osteomyelitis

Retrieved on: 
Monday, August 15, 2022
FDA, U.S. Securities and Exchange Commission, Lysin, Pneumonia, Forward-looking statement, Trial of the century, GLOBE, Death, Daptomycin, Clinical trial, Campaign, Breakthrough therapy, Security (finance), DLA, Research, S. aureus, Biofilm, Enterobacter, Patient, State, Osteomyelitis, Bacteria, Pseudomonas aeruginosa, Subclinical infection, SOC, Infection, MRSA, Staphylococcus epidermidis, Manuscript, Maintenance, Acinetobacter baumannii, Journal, Nasdaq, Peptide, Endocarditis, Pharmaceutical industry

This manuscript presents the results from a study evaluating the activity of exebacase or the CF-296 lysin in a preclinical rabbit model of implant-associated methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.

Key Points: 
  • This manuscript presents the results from a study evaluating the activity of exebacase or the CF-296 lysin in a preclinical rabbit model of implant-associated methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
  • Notably, the administration of exebacase alone, without systemic antibiotics, resulted in significant reductions in MRSA counts compared to controls.
  • Furthermore, either exebacase or CF-296, used in addition to systemically administered daptomycin, also resulted in significant reduction in MRSA counts on infected implants compared to daptomycin alone.
  • Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made.

Everest Medicines Announces Regulatory Update and Strategic Partnership for Xerava™ in Taiwan

Retrieved on: 
Thursday, August 11, 2022
Social conditions in Honduras, Gastrointestinal tract, Cholecystitis, Aerobic organism, NDA, Peritonitis, MDR, Daptomycin, Technology, Multiplicity of infection, Philippe Ciais, Cancer, Life, Critical care, Marketing, Patient, Review, Bronchopneumonia, Stomach, Appendicitis, Company, Infection, HKEX, Partnership, Tetracycline, Doctor of Philosophy, Degenerative disease, Perforation, News, TTY, Gram-positive bacteria, Solution, CMC, Diverticulitis, Medicine, Food, Terminology, Pharmaceutical industry, Vaccine, Colistin, Eravacycline, Mount Everest, MD

SHANGHAI, Aug. 10, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).

Key Points: 
  • In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan.
  • It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing.
  • Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.
  • Everest Medicines has built a portfolio of elevenpotentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development.

Presentations at ASM Microbe Conference Demonstrate Potential of ContraFect’s Direct Lytic Agents (DLAs) to Address MRSA Infections

Retrieved on: 
Tuesday, June 14, 2022
Bloodstream infections, Subclinical infection, Campaign, Breakthrough therapy, Death, Pseudomonas aeruginosa, Șaeș, Vancomycin, Pneumonia, Conference, HHS, Forward-looking statement, CEO, Lysin, Security (finance), Staphylococcus, Hypersensitivity, U.S. Securities and Exchange Commission, Oxacillin, Nasdaq, Maintenance, Endocarditis, Enterobacter, Rockefeller University, DLA, FDA, GLOBE, MSSA, Patient, Mortality, BSI PAS 2060, Biofilm, BARDA, Daptomycin, Trial of the century, Methicillin-resistant Staphylococcus aureus, Acinetobacter baumannii, Clinical trial, ASPR, CFU, Infection, SOC, MRSA, CFU-GEMM, MIC, Osteomyelitis, Bacteria, S. aureus, Peptide, Antibiotics, Pharmaceutical industry

These data were recently presented at the ASM Microbe Conference held in Washington, D.C. from June 9-13, 2022.

Key Points: 
  • These data were recently presented at the ASM Microbe Conference held in Washington, D.C. from June 9-13, 2022.
  • These results demonstrate that lysins offer a potentially effective strategy for treating implant-associated MRSA osteomyelitis infections.
  • These in vitro studies demonstrate the low propensity for the development of resistance to exebacase in both MRSA and methicillin-sensitive S. aureus (MSSA) strains.
  • 28-day serial passage resistance assays demonstrated that the minimum inhibitory concentration (MIC) of exebacase was not increased against MRSA and MSSA.

Zai Lab Announces Promotion of Harald Reinhart, M.D. to President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases

Retrieved on: 
Wednesday, December 22, 2021
U.S. Securities and Exchange Commission, Novartis, Drug development, Medicine, Transplant, Anesthesiology, Kidney, Acarbose, Patient, Immunity, Private Securities Litigation Reform Act, Coronavirus, Internal medicine, Infection, CEO, Medical Affairs Bureau, CMO, International development, Degenerative disease, Diabetes, NASDAQ, University, Senior, Forward-looking statement, Health, COVID-19, Autoimmunity, Faculty, Artemether/lumefantrine, Allergy, Yale school, Zai, Ciprofloxacin, SAN, Â, Risk, GLOBE, Pharmaceutical industry, Telbivudine, Daptomycin, Neuroscience

Dr. Reinhart has been with the company since inception, first as an advisor and since 2017, as Chief Medical Officer responsible for the autoimmune and infectious diseases portfolio.

Key Points: 
  • Dr. Reinhart has been with the company since inception, first as an advisor and since 2017, as Chief Medical Officer responsible for the autoimmune and infectious diseases portfolio.
  • Harald has played a pivotal role in building Zai Labs broad and deep pipeline in autoimmune, infectious diseases and neuroscience, said Dr. Samantha Du, Founder, Chairperson and CEO at Zai Lab.
  • This promotion not only recognizes Haralds tremendous contributions but will also empower him to further build a leading clinical team across these therapeutic areas.
  • He completed his medical and subspecialty training in the U.S. with board-certifications in internal medicine and infectious diseases.

Merck Issues Voluntary Nationwide Recall of CUBICIN® (daptomycin for injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

Retrieved on: 
Wednesday, October 20, 2021
Biotechnology, Pharmaceutical, Health, MSD, Online, Wake Up (Next to You), MRK, Twitter, Skin, Security (finance), Adult, Vaccine, Sedgwick, Instagram, Patient, United States Postal Service, Coronavirus, Infection, Animal, Safety, Glass, Risk, COVID-19, USPS, LinkedIn, Medicine, Swelling, YouTube, Staphylococcus, Knowledge, Head, Population, SEC, Food, Patent, Blood, Life, NDC, Intravenous therapy, News, Atmosphere of Earth, Annual report, U.S. Securities and Exchange Commission, FDA, EST, Health, MPH, Private Securities Litigation Reform Act, Cancer, Completeness, Hospital, Merck & Co., NYSE, Daptomycin, Subclinical infection, Lot, Multimedia, Research, Particulates, Regulation of tobacco by the U.S. Food and Drug Administration, HIV, Medical device, Pharmaceutical industry, Mail, Dietary supplement

The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution.

Key Points: 
  • The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution.
  • Local irritation or swelling at the infusion site may occur in response to the presence of foreign material.
  • CUBICIN is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake, NDC 67919-011-01.
  • The affected CUBICIN lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022.

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Retrieved on: 
Monday, September 13, 2021
Russell Microcap Index, Program, QIDP, Absorption, HERE, Traction, CEO, Private Securities Litigation Reform Act, FDA, IPO, Minimum inhibitory concentration, Hand, Marketing, Patient, Infection, SMMT, Colon, Acrux, Ridinilazole, LLC, Optimism, Risk, Clinical trial, Kepler-86, Advertising, Daptomycin, Congress, NASDAQ, Stock dilution, Review, MIC, Death, Recurrence, Fast track (FDA), Goal, SEC, Research, HPM, Phase 3, Fine chemical, Risk management, Pharmaceutical industry, Antibiotics, Dietary supplement, Security (finance)

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Retrieved on: 
Monday, September 13, 2021
Russell Microcap Index, Program, QIDP, Absorption, HERE, Traction, CEO, Private Securities Litigation Reform Act, FDA, IPO, Minimum inhibitory concentration, Hand, Marketing, Patient, Infection, SMMT, Colon, Acrux, Ridinilazole, LLC, Optimism, Risk, Clinical trial, Kepler-86, Advertising, Daptomycin, Congress, NASDAQ, Stock dilution, Review, MIC, Death, Recurrence, Fast track (FDA), Goal, SEC, Research, HPM, Phase 3, Fine chemical, Risk management, Pharmaceutical industry, Antibiotics, Dietary supplement, Security (finance)

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

ContraFect Announces Multiple Publications on CF-296 Demonstrating Potent In Vivo Antimicrobial Activity

Retrieved on: 
Monday, July 19, 2021
Peptides, Infectious diseases, Health care, Bacterial diseases, Antibiotics, Healthcare-associated infections, Cyclic peptides, Depsipeptides, Daptomycin, Methicillin-resistant Staphylococcus aureus, Vancomycin

The analysis of bone samples demonstrated that CF-296 has potent anti-staphylococcal activity and, when used with daptomycin, is active and well tolerated in MRSA acute osteomyelitis.

Key Points: 
  • The analysis of bone samples demonstrated that CF-296 has potent anti-staphylococcal activity and, when used with daptomycin, is active and well tolerated in MRSA acute osteomyelitis.
  • Of note, the addition of CF-296 to both daptomycin or vancomycin resulted in significantly enhanced antibacterial activity in the model, relative to the activity of these standard-of-care antibiotics alone.
  • ContraFect continues to evaluate CF-296 in further preclinical studies and the potential for future clinical development.
  • CF-296 was developed by ContraFect and the Company is actively pursuing global rights to this investigational development candidate.

Dr. Reddy’s Q3 & 9M FY21 Financial Results

Retrieved on: 
Friday, January 29, 2021
Biotechnology, Pharmaceutical, Health, Antibiotics, Daptomycin, Depsipeptides, Lipopeptides, Branches of biology, Molecular biology, Biology

This included Cinacalcet Tablets, Sapropterin Dihydrochloride Tablets and Succinylcholine Chloride Injection in the US along with Daptomycin Injection in Canada.

Key Points: 
  • This included Cinacalcet Tablets, Sapropterin Dihydrochloride Tablets and Succinylcholine Chloride Injection in the US along with Daptomycin Injection in Canada.
  • As of 31st December 2020, cumulatively 89 generic filings are pending for approval with the USFDA (87 ANDAs and 2 NDAs under 505(b)(2) route).
  • Of the 89 ANDAs, 48 are Para IVs and we believe 24 have First to File status.
  • As % to revenues these are: Q3 FY21: 8.3% | Q2 FY 21: 8.9% | Q3 FY20: 9.0%.

Sandoz acquires US distribution rights to two key hospital injectable medicines, reinforcing strategic focus on key growth segment

Retrieved on: 
Monday, March 23, 2020
Communication, Forward-looking statement, Articles, Risk, Belief, Daptomycin, Molecular biology, Academic disciplines

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.

Key Points: 
  • This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
  • Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties.
  • Neither can there be any guarantee that the daptomycin or fosaprepitant products will be commercially successful in the future.
  • Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs.