Bronchopneumonia

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
Thursday, April 4, 2024
Disease, MSSA, MRSA, Development, TARGET, Associate, Partnership, CABP, New Drug Application, Patient, HHS, Mortality, NDA, Fungal infection, Staphylococcus aureus, Bronchopneumonia, Infection, Safety, SAB, ASPR, Staphylococcus, Ceftobiprole, Administration, FDA, ABSSSI, Pharmaceutical industry

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6

Retrieved on: 
Tuesday, February 20, 2024
Infection, Acinetobacter baumannii, FDA, Food, ABC, Bronchopneumonia, AMP, Phenotype, Patient, CSO, Gram-negative bacteria, IND, VABP, Pharmaceutical industry

JERUSALEM, Israel, February 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.

Key Points: 
  • Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.
  • OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides.
  • In November 2023, Omnix Medical had been granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).
  • "We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical.

Basilea provides portfolio status update

Retrieved on: 
Friday, January 5, 2024
European Commission, Partnership, Yeast, ABSSSI, Fungus, FDA, Antifungal, PDUFA, DXR, WHO, European, Staphylococcus aureus, Genetically modified bacteria, NDA, Bronchopneumonia, SAB, Civil service commission, USD, Infection, Candida auris, Fungal infection, World Health Organization, Biofilm, Patient, Staphylococcus, CABP, Pharmaceutical industry

By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.

Key Points: 
  • By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.
  • In August, Basilea submitted a similar application for a pediatric label extension of Cresemba in the European Union and anticipates a decision by the European Commission around mid-2024.
  • Basilea expects to enter into a commercialization partnership agreement for ceftobiprole in the US prior to the FDA decision.
  • For fosmanogepix, Basilea anticipates to start a phase 3 study in invasive yeast infections mid-2024 and a phase 3 study in invasive mold infections, by year-end 2024.

Paratek Pharmaceuticals Announces Inclusion of Oral NUZYRA® in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, December 13, 2023
Food, ABSSSI, Bronchopneumonia, NMPA, Public, NRDL, Patient, Safety, CABP, Pharmaceutical industry

Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.

Key Points: 
  • Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.
  • “The addition of oral NUZYRA to China’s NRDL allows millions of patients increased accessibility, at reduced prices, to the once-daily oral and IV formulations of this life-saving therapy for serious community-acquired infections,” said Evan Loh, M.D., Paratek chief executive officer.
  • “This inclusion further expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis.
  • Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.

Global Platform Study Presents Results to Guide Care of Severely Ill Patients With COVID-19 Using Routinely Available Drugs – Simvastatin and Vitamin C

Retrieved on: 
Wednesday, October 25, 2023
Science, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Hospitals, Clinical Trials, WHO, Urinary tract infection, Survival, FRCP, Patient, Vitamin C, Simvastatin, Royal Victoria Hospital, Montreal, Bronchopneumonia, MPH, Global Coalition Against Pneumonia, Oregon Health & Science University, University, Respiratory tract infection, JAMA, Professor, Vitamin, Multimedia, Queen's University Belfast, University of Pittsburgh School of Medicine, Learning, Critical Care Medicine (journal), COVID, Clinical trial, Intensive care unit, Hospital, NEJM, Probability, Pittsburgh, European Society of Clinical Microbiology and Infectious Diseases, Wilfrid Sellars, SUNY Downstate Health Sciences University, Hospice and palliative medicine, Intensive care medicine, Royal Victoria Hospital, UPMC, Consultant, Ohio State University Wexner Medical Center, Pharmaceutical industry, Dietary supplement, MD

Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.

Key Points: 
  • Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.
  • Through harmonizing two clinical trials – REMAP-CAP and LOVIT-COVID – over 2500 patients in 20 countries took part, including both critically ill and non-critically ill patients with COVID-19 in hospital.
  • It was shown that high dose vitamin C did not improve outcomes for patients.
  • Intravenous Vitamin C for Patients Hospitalized with COVID-19: Two Harmonized Randomized Clinical Trials.

Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

Retrieved on: 
Tuesday, October 17, 2023
Efficacy, Staphylococcus, Methicillin-resistant Staphylococcus aureus, Ambrose, Abstract, Treatment, Clinical, Circulatory system, MRSA, Biomedical Advanced Research and Development Authority, BARDA, Enterococcus faecalis, Infection, ASPR, MSSA, IDSA, Isolates, Laboratory, Liolios Xirolivaditis, Staphylococcus aureus, PK/PD models, SAB, ABSSSI, CABP, Bronchopneumonia, Administration for Strategic Preparedness and Response, Streptococcus pneumoniae, Prescription Drug User Fee Act, Duke University School of Medicine, Infectious Diseases Society of America, Randomness, Development, Administration, Safety, Patient, PDUFA, HHS, Pharmaceutical industry, Vaccine, Ceftobiprole, Litherland, Enterococcus, Allschwil, Streptococcus, Bloodstream infections

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.
  • It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies.
  • Abstract #1946 – In Vitro Activity of Ceftobiprole against Staphylococcus aureus Bacteremia Isolates from the United States (2018–2020) – L. Duncan, M. Castanheira, J. I.
  • Smart, M. E. Jones, P. G. Ambrose, K. Litherland
    Abstract #2561 – Population Pharmacokinetic Analyses for Ceftobiprole Using Data from Phase 1 and 3 Studies – A. P. Cammarata, K. Litherland, M. C. Safir, S. M. Bhavnani, M. Saulay, J. I.

ContraFect Announces FDA Clearance of CF-370 IND Application to Proceed With Phase 1 Clinical Study

Retrieved on: 
Monday, October 16, 2023
Infection, Klebsiella pneumoniae, Hospital, Disease, Food, Gram-negative bacteria, Campaign, Fungal infection, HAI, Trial of the century, Bacteria, Acinetobacter baumannii, Escherichia coli, Intellectual property, IND, CDC, Mortality, Enterobacter cloacae, VABP, State, Pseudomonas aeruginosa, Patient, FDA, XDR, MDR, Peptide, Clinical trial, Pneumonia, Gram, ICU, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Enterobacter, Bronchopneumonia, Pharmaceutical industry, MD, Enterobacteriaceae

“We are very pleased with the FDA’s clearance of our IND application for CF-370.

Key Points: 
  • “We are very pleased with the FDA’s clearance of our IND application for CF-370.
  • HABP/VABP occurs in patients in hospitals or other health care facilities and can be caused by a variety of bacteria.
  • P. aeruginosa, Acinetobacter species, Klebsiella species, E. coli and Enterobacter species are the most commonly implicated Gram-negative pathogens in HABP/VABP infections.
  • The HAI Progress Report includes data from 3,917 facilities reporting to the National Healthcare Safety Network covering 36.3 million hospital admissions.

Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

Retrieved on: 
Monday, October 2, 2023
SAB, ASPR, US Foods, Prescription Drug User Fee Act, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, PDUFA, Infection, Fungal infection, FDA, Safety, BARDA, TARGET, Pharmaceutical industry, Allschwil, New Drug Application

Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024

Key Points: 
  • Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024
    Ad hoc announcement pursuant to Art.
  • 53 LR
    Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year.
  • The FDA has set April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal date.
  • Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the PDUFA goal date.

Gurnet Point Capital and Novo Holdings A/S Complete Acquisition of Paratek Pharmaceuticals, Inc.

Retrieved on: 
Thursday, September 21, 2023
CVR, Bronchopneumonia, Public, Calendar, CABP, ABSSSI, Acquisition, Novo Holdings A/S, Gurnet Point, Massachusetts, Novo Nordisk Foundation, Contingent value rights, Pharmaceutical industry

CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Gurnet Point Capital (“Gurnet Point”) and Novo Holdings A/S (“Novo Holdings”) announced today the completion of their acquisition of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”) (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel therapies for life-threatening diseases and other public health threats.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Gurnet Point Capital (“Gurnet Point”) and Novo Holdings A/S (“Novo Holdings”) announced today the completion of their acquisition of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”) (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel therapies for life-threatening diseases and other public health threats.
  • “Today’s completion of the acquisition of Paratek by Gurnet Point and Novo Holdings represents the beginning of a new chapter in our Company’s history,” said Evan Loh, M.D., Chief Executive Officer at Paratek.
  • Under the terms of the merger agreement, Gurnet Point, a leading healthcare investment firm, and Novo Holdings, a holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, acquired all outstanding shares of Paratek for approximately $462 million, including the assumption of debt and assuming full payment of a CVR.
  • Stockholders approved the merger agreement proposal at Paratek's special meeting of stockholders on September 18, 2023 in connection with the previously announced definitive agreement between the Company, Gurnet Point and Novo Holdings.