Hospital-acquired pneumonia

European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options

Retrieved on: 
Monday, April 22, 2024
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Mortality, Urinary tract infection, Pyelonephritis, WHO, News, World Health Organization, Safety, Infection, European Commission, Bacteria, Inc., AMR, Aztreonam, HAP, Fungal infection, VAP, Hospital-acquired pneumonia, Gram-negative bacteria, Patient, PFE, Ventilator-associated pneumonia, Parasitism, Multiple drug resistance, Virus, Civil service commission, Fungus, Antimicrobial resistance, Head, Disease, Gram, Vaccine

(NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.

Key Points: 
  • (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.
  • It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.
  • “For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study.
  • Marketing authorization applications for EMBLAVEO are planned for submission in other countries.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024

Retrieved on: 
Sunday, February 4, 2024
Civil service commission, Pneumonia, Febrile neutropenia, Eli Lilly, Triprolidine, International, Bacteria, Schizophrenia, Myelopathy, Incidence, ALD, Cefepime, Allergic rhinitis, Nasal congestion, Neutrophil, Agency, COMP, Fever, HAP, EEIG, Headache, Static pressure, Medicine, Committee, Conditional, Spinal cord, Hospital-acquired pneumonia, PTC, Neutropenia, Public, CHMP, European, AMD, Patient, Diagnosis, Marketing, RCVS, European Commission, Brain, Disease, Infection, Inflammation, Male, PRES, PRAC, Pain, Pyelonephritis, Urinary tract infection, VAP, Ageing, EMA, Geographic atrophy, Adrenoleukodystrophy, Therapy, News, INN, Duchenne muscular dystrophy, Common, Fungal infection, Vaccine

Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.

Key Points: 
  • Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.
  • Ltd. Marketing-authorisation holderVarious companiesMore informationSynapse

PHAXIAM Therapeutics extends its phage portfolio to Klebsiella pneumoniae, a new resistant and aggressive bacterial target

Retrieved on: 
Tuesday, September 19, 2023
Infection, S. aureus, Escherichia coli, Pyogenic liver abscess, Hospital-acquired pneumonia, Urinary tract infection, Klebsiella pneumoniae, Lung, Incidence, Fungal infection, Patient, Blood, CEST, Mortality, Alcoholism, United, Immunodeficiency, Therapy, Pneumonia, Pseudomonas aeruginosa, Vaccine

Klebsiella pneumoniae (K. pneumoniae) causes a wide range of infections, including pneumonia, urinary tract infections, bacteremia and liver abscesses, and mainly infects immunocompromised people.

Key Points: 
  • Klebsiella pneumoniae (K. pneumoniae) causes a wide range of infections, including pneumonia, urinary tract infections, bacteremia and liver abscesses, and mainly infects immunocompromised people.
  • However, the emergence and spread of hypervirulent and multi-resistant strains of this bacterium have recently extended its potential targets to people with no health problems.
  • In Western countries, we estimate that between 3% and 5% of pneumonias are linked to an infection caused by K. pneumoniae.
  • Our anti-Klebsiella phages will thus complement an already extended phage portfolio for the clinical indications we are targeting, and reinforce our ability to efficiently address a broad spectrum of resistant bacterial infections.”

Biobot Analytics Launches Respiratory Illnesses Panel

Retrieved on: 
Thursday, August 24, 2023
Norovirus, Nicotine, Methamphetamine, Hospital, SARS-CoV-2, Infection, Hospital-acquired pneumonia, COVID-19, Sewage, Intelligence, CDC, Epidemic, Death, RSV, Cocaine, Virus, Fentanyl, Vaccine

CAMBRIDGE, Mass., Aug. 24, 2023 /PRNewswire/ -- Biobot Analytics, a global leader in wastewater intelligence, announced today that it is launching a Respiratory Illnesses Panel that will include concurrent wastewater monitoring for Influenzas A and B (seasonal flu), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 (COVID-19).

Key Points: 
  • The Respiratory Illnesses Panel will include monitoring for Influenza A and B, RSV, and SARS-CoV-2
    CAMBRIDGE, Mass., Aug. 24, 2023 /PRNewswire/ -- Biobot Analytics, a global leader in wastewater intelligence, announced today that it is launching a Respiratory Illnesses Panel that will include concurrent wastewater monitoring for Influenzas A and B (seasonal flu), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 (COVID-19).
  • Wastewater monitoring has proved to be a critical infrastructure for tracking the spread of respiratory illnesses within populations.
  • Biobot's Respiratory Illnesses Panel builds on the company's continuous efforts to transform wastewater infrastructure into real-time health observatories.
  • For more information on Biobot's wastewater intelligence platform, or to sign up to learn when the Respiratory Illnesses Panel becomes available for your community, visit our website .

Aridis Pharmaceuticals Announces First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, June 8, 2023
Biologics license application, US Foods, Community-acquired pneumonia, MSSA, S. aureus, Methicillin, CAP, Infection, MRSA, Clinical trial, Pharmacokinetics, Cystic fibrosis, Hospital-acquired pneumonia, Melinda French Gates, Staphylococcus, Immunotherapy, AstraZeneca, Staphylococcus aureus, Trial of the century, DE, Pseudomonas aeruginosa, Apex, Phase 10, Development, CFF, Bill & Melinda Gates Foundation, Expense, Patient, Immunoglobulin G, Met, VAP, Administration, Cystic Fibrosis Foundation, Ventilator-associated pneumonia, LOS, Bacteria, Gallium, Research, Gates, FDA, HAP, BLA, ICU, Pneumonia, Safety, Pharmaceutical industry, Cryptocurrency, COVID-19, Kermode

LOS GATOS, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today reported financial and corporate results for its first quarter ended March 31, 2023.

Key Points: 
  • LOS GATOS, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today reported financial and corporate results for its first quarter ended March 31, 2023.
  • “Our first quarter results demonstrate the continued progress and momentum of Aridis Pharmaceuticals.
  • First Quarter 2023 Financial Results:
    Cash: Total cash, cash equivalents and restricted cash as of March 31, 2023, were approximately $1.8 million.
  • Change in Other Comprehensive Income: Change in other comprehensive income increased by approximately $861,000 for the quarter ended March 31, 2023 from $0 for the quarter ended March 31, 2022.

Hospital Acquired Disease Testing Market Report 2022: Environment Analysis, Market Trends, Competitive Intelligence - ResearchAndMarkets.com

Retrieved on: 
Monday, December 19, 2022
Health, Hospitals, HAI, Subclinical infection, Hospital, Mortality, Hospital-acquired pneumonia, Patient, Infection, Ventilator-associated pneumonia, Hospital-acquired infection, Growth, Subcutaneous tissue, Risk, Urinary tract infection, Disease, Methicillin-resistant Staphylococcus aureus, Immunity, Pneumonia, Parent, MRSA, Caregiver, Eyeish, Skin, Intelligence, Vaccine, Medical imaging, Marketing

The global hospital acquired disease testing market report studies this market in terms of major types of HAIs.

Key Points: 
  • The global hospital acquired disease testing market report studies this market in terms of major types of HAIs.
  • Qualitative information such as drivers, challenges, and future prospects for the global hospital acquired disease testing market are included in this report.
  • What are the key micro and macro environmental factors that are impacting the growth of Hospital Acquired Disease Testing market?
  • Who are the key competitors and what are their key strategies to enhance their market presence in the Hospital Acquired Disease Testing market worldwide?

Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

Retrieved on: 
Wednesday, November 30, 2022
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Result, Infection, GSK, Incidence, Skin, Financial condition report, Communication, BLI, Nephrotoxicity, Food, Pneumonia, Safety, Colistin, Therapy, ABC, Distributive shock, Kidney failure, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, Agency, Analysis, Priority review, Hospital-acquired pneumonia, MD, Disease, Multiplicity of infection, Security (finance), NDA, Subclinical infection, Bloodstream infections, Time-invariant system, Blood pressure, Septic, II, Angiotensin, Fluticasone furoate/umeclidinium bromide/vilanterol, Data analysis, Coronavirus, Priority, PDUFA, FDA, Sulbactam, Pharmaceutical industry, Vaccine

The Agency is currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The Agency is currently planning to hold an advisory committee meeting to discuss this application.
  • SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
  • Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
  • Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.

Menarini and SciClone Sign Exclusive Licensing Agreement to Develop and Commercialize Vaborem® in China to Treat Antimicrobial Resistant Infections

Retrieved on: 
Tuesday, September 20, 2022
People, CRKP, Group, World, Klebsiella pneumoniae, Health, KPC, Infection, HKEX, Prevalence, LLC, Hospital-acquired pneumonia, Commonwealth, Klebsiella, HAP, Republic, World Health Organization, Holding, Meropenem, Partnership, Menarini, Therapy, Patient, Cancer, Contributor License Agreement, Vaborbactam, Injection, Philippe Ciais, CRE, Toxic shock syndrome, License, Urinary tract infection, Marketing, Union, Cutis marmorata telangiectatica congenita, Mortality, Serine, Antibiotics, Pharmaceutical industry, Hospital, Meropenem/vaborbactam, Melinta Therapeutics

Ltd., part of The Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem(meropenem and vaborbactam) in the People's Republic of China (China).

Key Points: 
  • Ltd., part of The Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem(meropenem and vaborbactam) in the People's Republic of China (China).
  • This initiative serves to expand options to address the public health threat of antimicrobial resistant infections, specifically carbapenem-resistant Enterobacterales (CRE).
  • According to China Antimicrobial Surveillance Network (CHINET), theincidence ofcarbapenem-resistantKlebsiella pneumoniae (CRKP) infections has experienced a steep increase in the last 10 years.
  • "We are excited to partner with Menarini to develop and commercialize Vaboremin China and bring better treatment options to patients with severe ailments.

Menarini and SciClone Sign Exclusive Licensing Agreement to Develop and Commercialize Vaborem® in China to Treat Antimicrobial Resistant Infections

Retrieved on: 
Tuesday, September 20, 2022
People, CRKP, Group, World, Klebsiella pneumoniae, Health, Minocycline, KPC, Infection, HKEX, Prevalence, LLC, Hospital-acquired pneumonia, Commonwealth, Klebsiella, HAP, World Health Organization, Holding, Republic, Meropenem, Partnership, Menarini, Therapy, Patient, Cancer, Contributor License Agreement, Vaborbactam, Injection, Philippe Ciais, CRE, Toxic shock syndrome, License, Urinary tract infection, Marketing, Union, Cutis marmorata telangiectatica congenita, Mortality, Multimedia, Serine, Antibiotics, Pharmaceutical industry, Hospital, Meropenem/vaborbactam, Melinta Therapeutics

Ltd., part of The Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem (meropenem and vaborbactam) in the People's Republic of China (China).

Key Points: 
  • Ltd., part of The Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem (meropenem and vaborbactam) in the People's Republic of China (China).
  • This initiative serves to expand options to address the public health threat of antimicrobial resistant infections, specifically carbapenem-resistant Enterobacterales (CRE).
  • According to China Antimicrobial Surveillance Network (CHINET), theincidence ofcarbapenem-resistantKlebsiella pneumoniae (CRKP) infections has experienced a steep increase in the last 10 years.
  • "We are excited to partner with Menarini to develop and commercialize Vaborem in China and bring better treatment options to patients with severe ailments.

Basilea announces Zevtera® (ceftobiprole) marketing authorization in Brazil

Retrieved on: 
Tuesday, July 12, 2022
Isavuconazonium, CAP, Marketing, MSSA, SIX Swiss Exchange, Communication, Gram-negative bacteria, Infection, HAP, TSX, Ceftobiprole, Methicillin-resistant Staphylococcus aureus, Patient, Ventilator-associated pneumonia, GUD, Adult, Community-acquired pneumonia, VAP, Hospital-acquired pneumonia, MRSA, MENA, Research, Mycosis, Pharmaceutical industry, Brazilian Health Regulatory Agency, Knight

David Veitch, Basileas Chief Executive Officer, stated: We are very pleased with the approval of Zevtera in Brazil.

Key Points: 
  • David Veitch, Basileas Chief Executive Officer, stated: We are very pleased with the approval of Zevtera in Brazil.
  • We look forward to working with Knight to make Zevtera available to patients in Brazil.
  • Knight has a strong local presence in Brazil, with a track record of successfully launching anti-infective brands in the country.
  • The grant of the marketing authorization triggered a milestone payment from Knight to Basilea.