Community-acquired pneumonia

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Emory University, Antigen, Streptococcus, International Society, HIV, Risk, Global health, Patient, Cohort, Hospital, Merck & Co., Aes, OPA, Epidemiology, Training school (United States), PCV20, Immunoglobulin G, Attenuated vaccine, MRK, Pediatrics, CDC, Vaccination, PPSV23, Community-acquired pneumonia, Food, FDA, PDUFA, Medicine, Vaccine

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024
PIN, Immunotherapy, Marketing, ADMA, Growth, Overalls, Patent, Death, Conference, Vaccine, Risk, Prevalence, Total revenue, GAAP, Depreciation, Patient, Vaccine-naive, FY, IVIG, Plasma, Mortality, CAP, Community-acquired pneumonia, EP

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its fourth quarter and full year 2023 financial results and provided a business update.
  • “We are pleased with our 2023 performance, which marked first-time positive adjusted net income on a full year basis.
  • We believe our unwavering focus on the immune deficient patient segment has allowed ADMA to establish itself as a premier provider of specialty biologics.
  • Fourth Quarter 2023 Financial Results:
    Total revenues were $73.9 million for the quarter ended December 31, 2023, as compared to $50.0 million for the quarter ended December 31, 2022, an increase of $23.9 million, or approximately 48%.

Grifols announces positive topline phase 3 fibrinogen clinical trial results

Retrieved on: 
Wednesday, February 14, 2024
Acquisition, Liver, Bleeding, MCE, USD, SCAP, Immunoglobulin M, FC, Fibrinogen, Wound healing, Standard of care, Fibrin, Risk, Safety, Immunoglobulin G, Element, GRFS, Medicine, Patient, Immunoglobulin A, AFD, Clinical trial, Protein, GRF, Plasma, Factor, CAP, Community-acquired pneumonia, Pharmaceutical industry

AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.

Key Points: 
  • AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.
  • Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing.
  • “The positive results for Biotest’s fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” said Victor Grifols Deu, Grifols Chief Operating Officer.
  • The acquisition of Biotest has significantly reinforced Grifols’ access to plasma, as well as the company’s pipeline and sales presence.

ADMA Biologics Announces Preliminary Fourth Quarter 2023 Revenue and Provides Business Update

Retrieved on: 
Monday, January 8, 2024
Marketing, Immunotherapy, Risk, Death, ADMA, Mortality, Patent, Community-acquired pneumonia, CAP, Adjustment, Total revenue, Vaccine-naive, Growth, Overalls, EP, FY, GAAP, Pet industry

FY 2024 and 2025 Total Revenue Guidance Increased to More than $320 Million and $370 Million, Respectively

Key Points: 
  • FY 2024 and 2025 Total Revenue Guidance Increased to More than $320 Million and $370 Million, Respectively
    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 08, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its preliminary unaudited fourth quarter and full year 2023 revenues and provided a business update.
  • Based on unaudited financial information, ADMA preliminarily estimates that its total revenue for the quarter- and year-ended December 31, 2023 will be between $72 million and $74 million and $256 million and $258 million, respectively.
  • The estimated Adjusted EBITDA amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort.
  • We estimate that an S. pneumonia hyperimmune globulin, if approved, has the potential to generate peak revenue of $300-500 Million.

Sigyn Therapeutics Releases Letter to Shareholders

Retrieved on: 
Thursday, January 4, 2024
Fresenius Medical Care, FDA, Hope, Health, Cancer, Inflammation, Patent, Lipopolysaccharide, Kidney disease, Horizon, Annual report, Death, University, IDE, Letter, Merck, Dialysis, Sepsis, Life, Antibody, Mortality, Therapy, Risk, Toxicity, Patient, Acquisition, AB toxin, ESRD, Hospital, Infection, SAN, DaVita Inc., Community-acquired pneumonia, Horizon Therapeutics, Roivant Sciences, Cardiovascular disease, Security (finance), Pharmaceutical industry

SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.

Key Points: 
  • SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.
  • The goal of this letter is to help you better understand our opportunities, our challenges, and decision-making processes.
  • In that submission, our endeavors were solely predicated on the development and clinical advancement of Sigyn TherapyTM.
  • This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties.

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Infection, Woman, Allergy, ABSSSI, ATC, Pneumonia, Aztreonam, Skin, International, Nausea, Language, Tissue, DNA, Mouth, Vancomycin, Community-acquired pneumonia, Antimicrobial spectrum, CAP, Quinolone antibiotic, Breastfeeding, European Medicines Agency, Tablet, Select, Patient, Birth, Bacteria, Anatomy, Moxifloxacin, IIA, Meglumine, Medical device

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

EQS-News: Biotest expands its clinical development program for trimodulin to patients with community-acquired pneumonia (CAP)

Retrieved on: 
Saturday, December 30, 2023
Urinary tract infection, Failure, Infection, Septic shock, Virus, Antibody, Pneumonia, Fungus, Lung, Mortality, Disease, Multiple organ dysfunction syndrome, Community-acquired pneumonia, Death, SCAP, CAP, COVID-19, Patient, Bacteria, Sepsis, Pharmaceutical industry

Biotest announced this week that the first hospitalized patient with Community-Acquired Pneumonia (CAP) has been treated in the multinational phase III TRICOVID trial.

Key Points: 
  • Biotest announced this week that the first hospitalized patient with Community-Acquired Pneumonia (CAP) has been treated in the multinational phase III TRICOVID trial.
  • The TRICOVID trial was already enrolling hospitalized patients with COVID-19 who require supplemental oxygen due to the severity of their disease.
  • However, trimodulin is not only expected to be effective in treatment of COVID-19 patients.
  • This further expedites the development of trimodulin as potential new treatment option for a broad population of hospitalized patients with CAP”, emphasized Dr Thomas Häder, Head of Clinical Strategy and Development at Biotest.

Senhwa Biosciences Received US FDA IND Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection

Retrieved on: 
Tuesday, November 21, 2023
Food and Drug Administration, CCL4, Food, Influenza, CAP, IL-6, IIT, Patient, CK2, César-Joseph Bourayne, Viral, Infection, COVID-19, Therapy, MCP-1, Virus, SARS-CoV-2, Community-acquired pneumonia, Drug development, Vaccine, Pharmaceutical industry, Silmitasertib

The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.

Key Points: 
  • The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.
  • Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses.
  • "Senhwa regards this phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses," said Jin-Ding Huang, CEO of Senhwa Biosciences, Inc.
  • Prior to this phase II study, Silmitasertib was investigated in two investigator-initiated trials (IIT) in the United States and has showed clinical benefits by accelerating the recovery speed in patients with moderate symptoms of COVID-19.

Safe Water For All

Retrieved on: 
Tuesday, November 14, 2023
French Foreign Legion, Disease, Research, Risk, Mortality, Patient, Multimedia, Pain, Community-acquired pneumonia, Human, Legionnaires' disease, Education, Vaccine, Dietary supplement

WASHINGTON , Nov. 14, 2023 /PRNewswire/ -- Safe water…..it is a human right many of us take for granted.

Key Points: 
  • WASHINGTON , Nov. 14, 2023 /PRNewswire/ -- Safe water…..it is a human right many of us take for granted.
  • Most never realize the exposures to potentially deadly waterborne pathogens lurking in our public water.
  • President of the board, Tonya Winders states, "For those living with compromised immune or lung health, Legionnaires' disease can be fatal.
  • Please join us in this important effort to ensure safe water for all!

EQS-News: Biotest’s Trimodulin shows reduced mortality in patients with severe community-acquired pneumonia through rapid normalisation of inflammation

Retrieved on: 
Thursday, December 14, 2023
University College London, Community-acquired pneumonia, Ventilation, Intensive care medicine, Immunoglobulin A, Mortality, Inflammation, Multiple organ dysfunction syndrome, Plasma, Septic shock, COVID-19, CAP, Antibody, Patient, Oxygen, Sepsis, SCAP, Immunoglobulin M, Immunoglobulin G, Immune system, Failure, Pneumonia, Vaccine, Pharmaceutical industry

The article describes new mechanisms by which trimodulin supports the immune system in patients with severe Community-Acquired Pneumonia (sCAP).

Key Points: 
  • The article describes new mechanisms by which trimodulin supports the immune system in patients with severe Community-Acquired Pneumonia (sCAP).
  • One major characteristic of sCAP patients is that their immune system becomes dysregulated, which results in inflammation.
  • The results reported, support the currently ongoing investigation of trimodulin in artificial ventilated patients with sCAP with evidence of significant inflammation (ESsCAPE trial).
  • In addition, trimodulin is currently also in development for the treatment of hospitalized, oxygen-supported patients with non-severe CAP, including COVID-19 (TRICOVID trial).