ARDS

Therapeutic Solutions International Files for Orphan Drug Designation Using JadiCell Adult Universal Donor Stem Cells for Treatment of Acute Respiratory Distress Syndrome

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월요일, 6월 26, 2023
Infectious Diseases, FDA, Neurology, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, General Health, Marketing, Umbilical cord, Internet, COVID-19, Clinical trial, TSOI, Emergency, Regenerative medicine, Orphan drug, Patient, Mortality, Pharmaceutical industry

Therapeutic Solutions International (TSOI) announced today filing with the FDA for Orphan Drug Designation for its JadiCell Adult Stem Cell Product for treatment of Acute Respiratory Distress Syndrome (ARDS).

Key Points: 
  • Therapeutic Solutions International (TSOI) announced today filing with the FDA for Orphan Drug Designation for its JadiCell Adult Stem Cell Product for treatment of Acute Respiratory Distress Syndrome (ARDS).
  • The Company has been advancing clinical use of this novel umbilical cord derived mesenchymal stem cell in the area of neurology and pulmonology with an FDA cleared clinical trial for COVID-19 associated ARDS.
  • Granting of Orphan Drug Designation would qualify JadiCells for certain benefits and incentives, including seven years of marketing exclusivity, tax credits for clinical trials, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application fees.
  • “We are thankful for the positive feedback we have been receiving from Key Opinion Leaders in the area of regenerative medicine and pulmonology which prompted us to pursue the Orphan Drug Designation for specific aspects of ARDS,” said Timothy Dixon, President, and CEO of the Company.

Innovation Pharmaceuticals Provides Update on U.S. Patent Applications Covering Use of Brilacidin in Inflammatory Bowel Diseases, Coronaviruses and Fungal Diseases

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수요일, 6월 21, 2023
Patent, Biomedical Advanced Research and Development Authority, Gastrointestinal tract, ALI, COVID-19, Infant respiratory distress syndrome, Nature Communications, OTCQB, HDP, Development, Patient, Ulcerative colitis, Biomarker, Acute respiratory distress syndrome, Host, BARDA, Pharmaceutical industry

Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.

Key Points: 
  • Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.
  • The Company out-licensed Brilacidin in UP/UPS to Alfasigma S.p.A. Brilacidin has also been evaluated in Phase 2 testing in moderate-to-severe hospitalized cases of COVID-19 (by intravenous delivery), with beneficial treatment effects observed in patient subgroups.
  • A separate patent application has been submitted to the USPTO for use of Brilacidin in fungal diseases.
  • Additional in vivo testing in efficacy models against two hard-to-treat fungal pathogens is scheduled for 3Q2023.

Global Acute Respiratory Distress Syndrome Market Report 2023-2028: Industry Trends, Growth, Impact of Inflation, Opportunities, Company Analysis - ResearchAndMarkets.com

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수요일, 6월 7, 2023
Pharmaceutical, Health, Medical Devices, Research and development, Failure, Bed, Hospital, COVID-19, Ageing, Risk, Lung, Government, Incidence, Chronic Respiratory Disease, Patient, Transfusion-related acute lung injury, Developed country, Viral, Acute respiratory distress syndrome, ICU, R, Air pollution, Diagnosis, White lung, Dietary supplement, Pharmaceutical industry, Medical device, Nursing, Growth

The "Acute Respiratory Distress Syndrome Market, Global Forecast 2023-2028, Industry Trends, Growth, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Acute Respiratory Distress Syndrome Market, Global Forecast 2023-2028, Industry Trends, Growth, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The other factors forecasted to propel the development of the worldwide acute respiratory distress syndrome (ARDS) market include the rising rate of air pollution and lifestyle-related diseases and Increasing accident rates and trauma-causing ARDS market.
  • However, the high cost of devices, lack of awareness about diseases, failure of trials for ARDS, and stringent regulation for approvals are the main factors restraining the global acute respiratory distress syndrome market.
  • In addition, nebulization devices dominate the acute respiratory distress syndrome market due to their low cost and wide availability.

StemInov Will Bioproduct the First Cell Therapy Drug to Treat Inflammatory Diseases

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월요일, 6월 5, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Health, Health Technology, Clinical Trials, Infection, French Government of the Hundred Days, Umbilical cord, Inflammation, Tech, Septic shock, Stem cell, Trial of the century, Intensive care medicine, Patient, Acute respiratory distress syndrome, B cell, Death, Pharmaceutical industry

StemInov, a biotechnology company developing an innovative biomedicine based on stem cells from umbilical cords to treat inflammatory diseases, septic shock and acute respiratory distress syndrome (ARDS), will bioproduct the first cell therapy drug from umbilical cord stem.

Key Points: 
  • StemInov, a biotechnology company developing an innovative biomedicine based on stem cells from umbilical cords to treat inflammatory diseases, septic shock and acute respiratory distress syndrome (ARDS), will bioproduct the first cell therapy drug from umbilical cord stem.
  • WhartSep, the drug bioproduced by a specific process developed by StemInov, is made of mesenchymal stem cells derived from the umbilical cord (Wharton Jelly WJ-MSC), which have very interesting properties for the treatment of inflammatory diseases.
  • Once manufactured, the biomedicine is frozen in vials that are directly injectable after thawing to patients in intensive care.
  • on June 7th at 2 pm" said Julie Hutin, CEO of StemInov.

The first Post-COVID Syndrome Phase II clinical trial has begun recruiting patients.

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목요일, 5월 25, 2023
Smell, Medicine, Taiwan, US Food Sovereignty Alliance, 2000 Goody's Body Pain 500, Long COVID, Fatigue, Arthralgia, Chills, COVID-19, Clinical trial, Food and Drug Administration, Chest pain, Statistics, Research, Brain, Multimedia, Cough, Cord blood, Myalgia, Patient, HPC, Timeline of the COVID-19 pandemic in the United Kingdom, WHO, FDA, Headache, Food, Pfizer, Pharmaceutical industry

BALDWIN PARK, Calif., May 25, 2023 /PRNewswire/ -- StemCyte announced it has officially begun recruiting patients under a US Food and Drug Administration (FDA) approved Phase IIa human clinical trial in the United States.

Key Points: 
  • BALDWIN PARK, Calif., May 25, 2023 /PRNewswire/ -- StemCyte announced it has officially begun recruiting patients under a US Food and Drug Administration (FDA) approved Phase IIa human clinical trial in the United States.
  • This is the world's first Phase II trial using umbilical cord blood cells to treat Post-COVID syndrome.
  • Cord Blood is a cell therapy biological drug that StemCyte is investigating to repair symptoms of Post-COVID Syndrome.
  • Currently, Pfizer's Paxlovid Phase III clinical trial and StemCyte's HPC, Cord Blood complement each other in treating Post-COVID Syndrome.

Revolo Biotherapeutics Presents New Preclinical Data for ‘1104 in Acute Respiratory Distress Syndrome Associated With Influenza Infection at the ATS 2023 International Conference

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월요일, 5월 22, 2023
IAV, Infection, Mouse, MOA, Eosinophilic esophagitis, TNF, Neutrophil, Allergy, Macrophage, Gastric lavage, ATS, Influenza A virus, IL-6, Inflammation, American Thoracic Society, Lung, Dexamethasone, Animal, International Conference on Emerging Infectious Diseases, Organic acid, Patient, Immune system, Viral, Viral load, Acute respiratory distress syndrome, Chemokine, Cytokine, Lymphocyte, Immunosuppression, Conference, PBS, Autoimmunity, Disease, Vaccine, Revolo

NEW ORLEANS and CAMBRIDGE, UK,, May 22, 2023 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced new preclinical data discussed in a poster presentation at the American Thoracic Society (ATS) 2023 International Conference. The poster showcases the ability of its immune-resetting drug candidate ‘1104 to inhibit and reduce lung inflammation without immunosuppression in a new model of acute respiratory distress syndrome (ARDS) associated with influenza infection.

Key Points: 
  • The poster showcases the ability of its immune-resetting drug candidate ‘1104 to inhibit and reduce lung inflammation without immunosuppression in a new model of acute respiratory distress syndrome (ARDS) associated with influenza infection.
  • “The data continues to highlight the unique mechanism of action (MOA) of ‘1104, acting ahead of the inflammatory cascade to reset the immune system.
  • Three days after infection, animals received either PBS (negative control) or 30µg of polyinosinic-polycytidylic acid (poly I:C) to exacerbate influenza-induced lung inflammation.
  • At 48 hours after the poly I:C challenge, bronchoalveolar lavage fluid was collected to conduct differential cell counts and to measure cytokines.

MediciNova Receives a Notice of Intention to Grant for a New Patent Covering MN-166 (ibudilast) for Patients with Microorganism Infection in Europe

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월요일, 5월 15, 2023
Code, COVID-19, Patent, MD, Patient, Risk, Tokyo Stock Exchange, Bacteria, MPH, Pneumonia, Mothers (Tokyo Stock Exchange), Respiratory failure, Vaccine, Doctor of Philosophy

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than February 2039.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than February 2039.
  • The allowed claims cover MN-166 (ibudilast) as a monotherapy in a patient diagnosed with or suffering from a microorganism infection.
  • The allowed claims cover a microorganism infection caused by a virus, bacteria, fungus, or any combination of two or more thereof.
  • We believe this patent broadly covers microorganism infection and will substantially increase the potential value of MN-166 as it further strengthens and expands our patent portfolio.”

MiNK Therapeutics Reports Corporate Update and First Quarter 2023 Financial Results

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목요일, 5월 11, 2023
AACR, Gene, ATS, Cancer, NSCLC, Cell, American Society of Gene and Cell Therapy, American Thoracic Society, Cytokine release syndrome, Memorial Sloan Kettering Cancer Center, Annual general meeting, Mink, Neoplasm, Therapy, Stomach, IND, Society, Abstract, Pharmaceutical industry, Vaccine, Cryptocurrency

MiNK to present an update on the novel FAP-CAR-iNKT IND-enabling program at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.

Key Points: 
  • MiNK to present an update on the novel FAP-CAR-iNKT IND-enabling program at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.
  • NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today provided a corporate update and reported financial results for the first quarter 2023.
  • Cash used in operations for the quarter ended March 31, 2023, was $4.4 million, compared to $4.2 million for the same period in 2022.
  • Net loss for the quarter ended March 31, 2023, was $5.7 million or $0.17 per share, compared to a net loss for the first quarter of 2022 of $7.8 million or $0.23 per share.

Veru Reports Fiscal 2023 Second Quarter Financial Results

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목요일, 5월 11, 2023
Operating cost, Internet, Telephone, Oxygen, Survival, Incidence, Capsule, Patient, Finasteride, Eli Lilly and Company, GPO, SERD, Agreement, Telehealth, BPH, Drug discovery, Animal law, Enobosarm, Metastasis, Comorbidity, FC2, FDA, IND, Combination, Safety, EUA, High Risk, CDK, COVID-19, Metastatic breast cancer, AGS, Trust, Mortality, LPC, ORR, SARS-CoV-2, NDA, Quality of life, Pharmacy, Prostate, Sale, Trial of the century, Emergency Use Authorization, Tadalafil, Treatment, Breast cancer, Vaccine, Pharmaceutical industry, Birth control, Reinsurance, Cryptocurrency, Virus

ET

Key Points: 
  • ET
    MIAMI, FL, May 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced financial results for its fiscal 2023 second quarter and provided a business update.
  • On March 30, 2023, the Company met with the FDA to gain further regulatory clarity for the ongoing Phase 2b/3 clinical trial design and program.
  • Cash and cash equivalents were $23.5 million as of March 31, 2023 versus $80.2 million as of September 30, 2022.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

BioCardia Reports First Quarter 2023 Business Highlights and Financial Results

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수요일, 5월 10, 2023
Partnership, Probability, Therapy, Heart failure, BCDA, DSMB, Echocardiography, New Drug Application, Pharmaceuticals and Medical Devices Agency, Quality of life, American College of Cardiology, Data monitoring committee, MSC, Patient, IRB, PMDA, Cardiology, Heart, Security (finance), Research, Phase, FDA, American College, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Breakthrough, Food, Safety, Pharmaceutical industry, Medical device, Cryptocurrency

SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.

Key Points: 
  • SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • In March, positive echocardiography data from the trial was presented at the 2023 American College of Cardiology annual meeting in New Orleans.
  • First Quarter 2023 Financial Results:
    Revenues were approximately $64 thousand for the three months ended March 2023, compared to approximately $60 thousand for the three months ended March 2022.