Pneumocystis pneumonia

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL due to Potential Bacillus cereus Contamination in the Product

Retrieved on: 
Tuesday, March 14, 2023
Online, Knowledge, Pharmacy, NDC, Pneumocystis pneumonia, Endocarditis, Food, FDA, UPC, Risk, Bacillus cereus, PCP, Necrosis, Multimedia, Completeness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HDPE, Nationwide, USP, Probability, Vaccine, Mail, Online shopping, Dietary supplement

PISCATAWAY, N.J., March 14, 2023 /PRNewswire/ -- Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.

Key Points: 
  • PISCATAWAY, N.J., March 14, 2023 /PRNewswire/ -- Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.
  • To date, Camber has not received any reports of adverse events related to this recall.
  • Atovaquone Oral Suspension, USP was distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.
  • Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email [email protected] , Monday – Friday, 9am – 5pm Eastern Time.

OpGen Announces Publication of Results of Unyvero Hospitalized Pneumonia (HPN) Panel for Detection of Bacterial Respiratory Tract Pathogens from Serial Specimens Collected from Hospitalized COVID-19 Patients

Retrieved on: 
Wednesday, June 22, 2022
Gold, Culture, Karolinska University Hospital, Immunodeficiency, Genetics, Bacterial pneumonia, PPV, Hospital, Pneumocystis pneumonia, Drug Quality and Security Act, PCR, GLOBE, Solution, KUH, Infection, Observation, Technology, Nadine Opgen-Rhein, Pneumonia, Private Securities Litigation Reform Act, Comparison, Nasdaq, Urinary tract infection, FDA, COVID-19, Evaluation, Adoption, Securities Act of 1933, Karolinska Institute, NGS, PCP, Bureau of Oceans and International Environmental and Scientific Affairs, Adult, HPN, Patient, Pneumocystis jirovecii, Diagnosis, Collection, Securities Exchange Act of 1934, LRT, Precision medicine, U.S. Securities and Exchange Commission, NPV, Goal, Vaccine, Pharmaceutical industry, MD

The publication highlights the ability of the Unyvero Hospitalized Pneumonia panel in detecting potential pneumonia pathogens earlier than culture or very early during an infection.

Key Points: 
  • The publication highlights the ability of the Unyvero Hospitalized Pneumonia panel in detecting potential pneumonia pathogens earlier than culture or very early during an infection.
  • This enables reliable and rapid diagnosis of pathogens of concern in these patients directly from native lower respiratory tract samples, and provides identification of bacterial co-infections in hospitalized patients with COVID-19 pneumonia in just five hours.
  • In their new publication titled Evaluation of a pneumonia multiplex PCR panel for detection of bacterial respiratory tract pathogens from serial specimens collected from hospitalized COVID-19 patients 2, the investigators conducted a follow-up study aimed to examine the concordant and discrepant results comparing the Unyvero HPN and culture results for detection of microorganisms from serial specimens collected from the same patient.
  • This press release includes statements regarding the publication of results of a recent study of the Unyvero Hospitalized Pneumonia panel.

Promising COVID-19 Therapeutic Drug to start Phase 3 Clinical Trial in the United States

Retrieved on: 
Monday, November 22, 2021
Patient, Fonds, Dapsone, CEO, Pneumocystis pneumonia, MUHC, McGill University, Safety, Kenya Medical Research Institute, Research institute, Hospital, Health, McGill University Health Centre, Health Canada, Inflammation, Solution, Faculty, Therapy, Institute, Lupus, COVID-19, Research, Montreal General Hospital, GLOBE, Medical school, Malaria, Tablet, Epidemiology, FDA, Mortality, Innovative Medicines Initiative, Infection, Glen, Acute respiratory distress syndrome, Nasal spray, HIV, Pharmaceutical industry

The drug was previously used to treat infectious diseases, including malaria, lupus, Human Immunodeficiency Virus (HIV) and pneumocystis pneumonia.

Key Points: 
  • The drug was previously used to treat infectious diseases, including malaria, lupus, Human Immunodeficiency Virus (HIV) and pneumocystis pneumonia.
  • Upon successful completion of the Phase 3 Clinical Trial, PULM-001 could be procured by governments and distributed through existing, well-established government networks.
  • The Phase 3 Clinical Trial will take place in North Carolina, Washington and Idaho under the sponsorship of Peters Medical Research and Principal Research Solutions.
  • Pulmonem anticipates a US$6 to $8 million financing will be required by early 2022 to complete the Phase 3 Clinical Trial.

IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control

Retrieved on: 
Wednesday, May 19, 2021
Chemical compounds, Organic compounds, Breakthrough therapy, Orphan drugs, Tyrosine kinase inhibitors, Health sciences, Acrylamides, Ibrutinib, Pyrazolopyrimidines, Bruton's tyrosine kinase, Pneumocystis pneumonia, PML

For more information, visit www.IMBRUVICA.com .\nHemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA.

Key Points: 
  • For more information, visit www.IMBRUVICA.com .\nHemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA.
  • Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA.
  • Up to 7 Years of Follow-up in the RESONATE-2 Study of First-Line Ibrutinib Treatment for Patients With Chronic Lymphocytic Leukemia.
  • The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia.

Key Publication of Clinical Study Demonstrates Unyvero Lower Respiratory Tract (LRT) Panel is Likely to Alter Antibiotic Management of Significant Numbers of Patients Presenting with Suspected Pneumonia

Retrieved on: 
Wednesday, September 2, 2020
Fungi, Infectious diseases, Ascomycota, Organisms, Medical specialties, HIV/AIDS, Pneumocystis pneumonia, Pneumocystis jirovecii, Pneumocystidomycetes, Pathogenic fungus, PJP, Pneumonia

Antibiotics could have been optimized in 7.8% of patients through both de-escalation and expansion.

Key Points: 
  • Antibiotics could have been optimized in 7.8% of patients through both de-escalation and expansion.
  • Unyvero LRT BAL is the only FDA-cleared lower respiratory tract infection panel that includes Pneumocystis jirovecii, a causative agent of Pneumocystis pneumonia (PJP) and a key fungal pathogen often found in immunocompromised patients that can be difficult to diagnose.
  • This press release includes statements regarding the potential impact on antibiotic therapy regimen and clinical utility of the Unyvero LRT and LRT BAL cartridges.
  • We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Verastem Oncology Announces COPIKTRA™ (Duvelisib) Presentations at the Society of Hematologic Oncology 2019 Annual Meeting

Retrieved on: 
Tuesday, September 3, 2019
Oncology, Health, Clinical trials, Pharmaceutical, Biotechnology, HIV/AIDS, Pneumonia, Pneumocystis pneumonia, Organ systems, PJP, Pneumocystis jirovecii, Marginal zone B-cell lymphoma, Medical specialties, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, COPIKTRA™ (duvelisib), Verastem Oncology

The fourth poster describes efficacy and safety data from the Phase 2 DYNAMO evaluating COPIKTRA patients with refractory marginal zone lymphoma (MZL).

Key Points: 
  • The fourth poster describes efficacy and safety data from the Phase 2 DYNAMO evaluating COPIKTRA patients with refractory marginal zone lymphoma (MZL).
  • Continued approval in FL may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Cases of Pneumocystis jirovecii pneumonia (PJP) (1%) and cytomegalovirus (CMV) reactivation/infection (1%) occurred in patients taking COPIKTRA.
  • Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation developed in 8% and 2%, respectively, of patients receiving COPIKTRA (N=442).

Verastem Oncology Presents COPIKTRA™ (Duvelisib) Data at the European Hematology Association 2019 Annual Meeting

Retrieved on: 
Monday, June 17, 2019
Health, Clinical trials, Genetics, Oncology, Pharmaceutical, Other Health, Research, Science, General Health, HIV/AIDS, Medical specialties, Medicine, Infectious diseases, Pneumocystis pneumonia, Pneumonia, Pneumocystis jirovecii, PJP, Infection, Signs and symptoms of HIV/AIDS, Congenital cytomegalovirus infection

Infections: Serious, including fatal (4%), infections occurred in 31% of patients receiving COPIKTRA (N=442).

Key Points: 
  • Infections: Serious, including fatal (4%), infections occurred in 31% of patients receiving COPIKTRA (N=442).
  • Median time to onset of any grade infection was 3 months, with 75% of cases occurring within 6 months.
  • Cases of Pneumocystis jirovecii pneumonia (PJP) (1%) and cytomegalovirus (CMV) reactivation/infection (1%) occurred in patients taking COPIKTRA.
  • Diarrhea or Colitis: Serious, including fatal (

SCYNEXIS to Present Pre-clinical Data Supporting Prophylactic Use of Ibrexafungerp at Superbugs and Superdrugs 2019

Retrieved on: 
Thursday, February 28, 2019
Chemical compounds, Drugs, RTT, Aromatic amines, Aromatic compounds, HIV/AIDS, Pneumocystis pneumonia, Pneumonia, Infectious diseases, Trimethoprim/sulfamethoxazole, Trimethoprim, Sulfameth

The presentation will take place on March 18th at 4PM GMT at Superbugs and Superdrugs 2019, March 18-20, 2019, in London.

Key Points: 
  • The presentation will take place on March 18th at 4PM GMT at Superbugs and Superdrugs 2019, March 18-20, 2019, in London.
  • The oral presentation, entitled: "Activity of oral ibrexafungerp in murine models of Pneumocystis pneumonia," will be delivered by Stephen A. Barat, Ph.D., Vice President, Pre-clinical Research and Early Clinical Development at SCYNEXIS.
  • The presentation highlights the results from multiple animal studies that evaluated oral ibrexafungerp versus both trimethoprim/sulfamethoxazole, which is the current standard of care for PCP, and vehicle control.
  • Oral ibrexafungerp demonstrated strong activity againstPCP in this model, as determined by a reduction in organism burden and improved survival.