Community-acquired pneumonia

EQS-News: Biotest increased sales by 83.6% to Euro 215.2 million in first quarter 2024

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金曜日, 5月 10, 2024
Birth, FDA, Phase, Pneumonia, Grifols, Technology transfer, Dreieich, Management, Fibrinogen, Immunodeficiency, Collection, Research, Community-acquired pneumonia, Factor, Biologics license application, ROCE, SCAP, Tax, Patient, Next Level, Health, Plasma, Disclosure, Video game

The Biotest Group recorded revenue of € 215.2 million in the first quarter of the 2024 financial year.

Key Points: 
  • The Biotest Group recorded revenue of € 215.2 million in the first quarter of the 2024 financial year.
  • EBIT for the first quarter of 2024 amounted to € 52.8 million, a significant improvement on the first quarter of the previous year (prior year period: € - 9.1 million).
  • The financial result for the first quarter of the current year deteriorated by € -1.4 million to € -10.7 million (prior-year period: € -9.3 million).
  • The Biotest Group's earnings after taxes improved to € 29.5 million in the first quarter of 2024 after € -20.4 million in the same quarter of the previous year due to the influencing factors described above.

ADMA Biologics Announces First Quarter 2024 Financial Results and Provides Business Update

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木曜日, 5月 9, 2024
Mortality, EP, KPI, FTE, Vaccine-naive, Risk, PIN, Phase 10, FY, ADMA, Immunotherapy, Conference, Plasma, Vaccine, Total revenue, Growth, Patent, Patient, Marketing, Death, Interim, Adjustment, GAAP, Overalls, Community-acquired pneumonia, Pet industry

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., May 09, 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 first quarter 2024 financial results and provided a business update.
  • “ADMA’s commercial success continues to unfold, and during the first quarter of 2024, we surpassed our financial expectations and delivered compounding earnings growth.
  • First Quarter 2024 Financial Results:
    Total revenues were $81.9 million for the quarter ended March 31, 2024, as compared to $56.9 million for the quarter ended March 31, 2023, an increase of $25.0 million, or approximately 44%.
  • As a result, ADMA achieved a corporate gross margin of 48% in the first quarter of 2024 as compared to 29% in the first quarter of 2023.

Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis

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木曜日, 4月 11, 2024
Doctor of Philosophy, UTI, Mortality, Randomized controlled trial, Urinary tract infection, Safety, High Risk, Sepsis, Immunotherapy, Septic shock, Ventilation, Community-acquired pneumonia, System, Patient, Therapy, Overalls, Infection, Pharmaceutical industry

Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population.

Key Points: 
  • Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population.
  • The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups.
  • Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates.
  • Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled.

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

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火曜日, 3月 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

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水曜日, 2月 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

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水曜日, 2月 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

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月曜日, 1月 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

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木曜日, 1月 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

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火曜日, 1月 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: 
土曜日, 12月 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.