The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses 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.

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The Pharma Data

OCTOBER 28, 2020

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).

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The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 6,7 Approximately 10% of asthma patients have severe asthma.

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The Pharma Data

DECEMBER 29, 2020

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.

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The Pharma Data

NOVEMBER 10, 2021

Next generation vaccines for COVID-19 should aim to induce an immune response 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.

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The Pharma Data

NOVEMBER 20, 2020

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 immune response or who have high viral load. Limitations of Authorized Use.

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The Pharma Data

APRIL 8, 2022

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 immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications. .

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The Pharma Data

JANUARY 17, 2021

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 immune responses. The NDA was built on data from the Phase III VICTORIA trial.

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The Pharma Data

OCTOBER 18, 2020

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).

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Codon

FEBRUARY 13, 2024

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.

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The Pharma Data

MARCH 11, 2021

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.”.

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The Pharma Data

NOVEMBER 21, 2020

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 immune response or who have high viral load. Limitations of Authorized Use.

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FDA Clinical Trials Hospitals Production 40

The Pharma Data

JULY 8, 2021

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.

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The Pharma Data

AUGUST 3, 2021

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.

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The Pharma Data

JUNE 18, 2021

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.

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The Pharma Data

NOVEMBER 29, 2020

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.

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The Pharma Data

OCTOBER 28, 2020

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.

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Codon

JULY 27, 2023

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 immune responses.

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Codon

JULY 27, 2023

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 immune responses.

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Therapies RNA DNA Engineering 52

The Pharma Data

SEPTEMBER 7, 2021

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.

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The Pharma Data

MARCH 29, 2022

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.

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Codon

SEPTEMBER 29, 2024

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 immune response, rapidly adopt new conformations to fit through tight cellular junctions, and self-replicate at safe background levels for years on end.

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The Pharma Data

OCTOBER 26, 2020

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.

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Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.

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The Pharma Data

FEBRUARY 8, 2021

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).

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The Pharma Data

FEBRUARY 4, 2021

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).

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Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

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%

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Vaccine Production FDA Disease 52

The Pharma Data

DECEMBER 20, 2020

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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