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(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.
It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. The study assesses the safety profile and immuneresponse when COVID-19 mRNA investigational booster vaccine (100 mcg dose) and high-dose quadrivalent influenza vaccine are administered simultaneously. About Sanofi.
.” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. ” Presentation number: 397P / Poster: ID 680.
Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. today announced that they have submitted Phase 1 data to the U.S.
In line with our global leadership and our 7 0-year history of pro tecting people with influenza v accine s , w e will always focus on developing product s that demonstrate protection beyond flu , as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia.
Immuneresponses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.
All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immuneresponses following the second dose of INO-4800.
The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania.
REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. placebo; p=0.024).
Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immuneresponse to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 6,7 Approximately 10% of asthma patients have severe asthma.
29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.
Next generation vaccines for COVID-19 should aim to induce an immuneresponse against ‘replication proteins’, essential for the very earliest stages of the viral cycle, concludes new research carried out by UCL scientists. ” Discovering the T cell response to replication proteins.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immuneresponse or who have high viral load. Limitations of Authorized Use.
Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immuneresponses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications. .
The primary endpoint of the study was composite of time to first occurrence of heart failure hospitalization or cardiovascular death. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immuneresponses. The NDA was built on data from the Phase III VICTORIA trial.
Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. Hospitals interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).
Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. There is also a growing body of successful treatments in the U.S., 4 But the same barriers still exist today.
These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. variant of SARS-CoV-2 (formerly referred to as the U.K. was the dominant strain.”.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immuneresponse or who have high viral load. Limitations of Authorized Use.
Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 2,6,9) Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.(10,11) Amgen (NASDAQ:AMGN) announced that the U.S.
The EUA now provides for the use of baricitinib for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The company and Pfizer Inc. Numbers may not add due to rounding.
PREVNAR 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. The indication for preventing pneumonia caused by S.
It also can cause more serious conditions like hepatitis and pneumonia, which often require hospitalization, as well as increase the likelihood of transplant rejection and graft-versus-host disease. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. About HOOKIPA
HOOKIPA Pharma Inc.
Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement.
There’s a TV show where a bunch of doctors are walking through a hospital corridor. In response, the U.S. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. a lower risk of immuneresponses.
There’s a TV show where a bunch of doctors are walking through a hospital corridor. In response, the U.S. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. a lower risk of immuneresponses.
Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Contributions to Research, Life-Sciences Industry.
Spinner, MD, Consulting Physician Infectious Diseases and Pandemic Officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, Munich, Germany, said: “Increasing COVID-19 cases, driven by the highly-transmissible BA.2 1-3 Evusheld was generally well-tolerated in the trial.
At best, the corporations with the best models released weak versions to the public under non-commercial licenses. The new viruses could shuffle surface antigens after encountering an immuneresponse, rapidly adopt new conformations to fit through tight cellular junctions, and self-replicate at safe background levels for years on end.
FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients. FDA Actions. Days after the U.S. Other Industry News.
This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immuneresponse to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.
In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).
In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).
to €401 million, driven by Rest of the World (up 50.7%), and Europe (up 10.5%) reflecting demand increase driven by recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition and postponed procedures. First-quarter Lovenox ® sales increased 30.4%
Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. ARCA biopharma enrolled the first patients in ASPEN-COVID-10, its Phase IIb trial of rNAPc2 for hospitalized COVID-19 patients.
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