pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

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Vaccine Vaccination Immune Response Gene Sequencing 64

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Humans as well as cats and dogs can be affected. .

Immune Response 52

Immune Response Licensing Licensing Sales 52

The Pharma Data

AUGUST 28, 2020

There are also plans to strengthen the Medicines and Healthcare products Regulatory Agency (MHRA)’s powers to roll out an unlicensed vaccine rapidly if one becomes available before the new year. Oxford coronavirus vaccine triggers immune response. UK signs deals for 90 million virus vaccine doses.

Vaccine 52

Vaccine Vaccination Immune Response Medicine 52

The Pharma Data

DECEMBER 17, 2020

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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

XTalks

FEBRUARY 19, 2024

In a recent study published by Weill Cornell Medicine in the Journal of Infectious Diseases , researchers have reported the potential of Moderna’s experimental mRNA vaccine in protecting adults against CMV, which could potentially also stop the transmission of the virus from mothers to their infants during pregnancy.

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Vaccine Vaccination Trials Clinical Trials 59

The Pharma Data

MAY 27, 2022

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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pharmaphorum

JUNE 24, 2022

The initiative will focus on vaccines and medicines for diseases like malaria, tuberculosis, HIV and neglected tropical diseases (NTDs), which according to the drugmaker account for 60% of the disease burden in poorer regions of the world, as well as antimicrobial resistance. GSK will invest around £1 billion ($1.2

Vaccination 59

Vaccination Vaccine Immune Response Development 59

pharmaphorum

DECEMBER 21, 2020

The deal-making activity signals Merck’s determination to stay at the forefront of cancer immunotherapy with new medicines that could complement Keytruda and broaden its portfolio. Earlier in the year there was also $2.55 billion alliance with Taiho and Astex for cancer antibodies, including a KRAS drug, and a $4.2

Immune Response 59

Immune Response Sales Antibody Drugs 59

The Pharma Data

AUGUST 16, 2021

These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. 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. This press release features multimedia. In the U.S.,

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Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

APRIL 26, 2022

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Immune Response 52

Immune Response Trials Protein Antibody 52

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. .

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

NOVEMBER 18, 2020

.” 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 52

Vaccination Vaccine Immune Response Trials 52

The Pharma Data

OCTOBER 19, 2020

Immune responses 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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

MARCH 25, 2022

This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 5-7) New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

The Pharma Data

JUNE 26, 2021

We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

Vaccine 52

Vaccine Vaccination Immune Response Licensing 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. Sergei Rudchenko, Ph.D.,

Vaccination 40

Vaccination Vaccine Development Medicine 40

pharmaphorum

JUNE 2, 2021

The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals.

Vaccine 52

Vaccine Vaccination Contract Manufacturing Production 52

The Pharma Data

MARCH 29, 2022

4-6 New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2 4-6 New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. Pfizer Inc. No new safety concerns were identified from the data available.

Vaccine 52

Vaccine Vaccination Production Immune Response 52

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. are immunocompromised or are on a medicine that affects the immune system. have a fever.

FDA Approval 102

FDA Approval Vaccine Vaccination Clinical Trials 102

The Pharma Data

SEPTEMBER 7, 2021

Throughout the COVID-19 pandemic, Bristol Myers Squibb has focused on ensuring the continued supply of our medicines to our patients and protecting the health, wellbeing and safety of our workforce. As a science-based company, we have a social responsibility to help reduce the spread of the virus. Workplace and Community.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

FEBRUARY 22, 2021

Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40

Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. is immunocompromised or is on a medicine that affects the immune system. NEW YORK and MAINZ, Germany, July 8, 2022 — Pfizer Inc. Emergency Use Authorization. has a fever.

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Vaccine Vaccination Clinical Trials Clinical Trials 81

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. This press release features multimedia. About Gilead Sciences. Gilead Sciences, Inc.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 22, 2021

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. About AstraZeneca. Liu C, et al. 2021 [link].

Trials 52

Trials Antibody Vaccination Vaccine 52

The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Participants received two 30 ?g g doses of the COVID-19 vaccine. The Pfizer?BioNTech

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 15, 2020

Scientists at Charité, University Medicine Berlin , have been able to use daratumumab to successfully treat two female patients who have systemic lupus erythematosus. The human monoclonal antibody targets specific immune plasma cells. New Immune System Cell. Monoclonal Antibodies. Oral, Small Molecules. Partnership Effort.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

XTalks

APRIL 2, 2021

Pfizer and German partner BioNTech are preparing to promptly submit the updated COVID-19 vaccine trial results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2. “We

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. are immunocompromised or are on a medicine that affects the immune system. a 3-dose primary series to individuals 6 months through 4 years of age. EMERGENCY USE AUTHORIZATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

AUGUST 16, 2021

Fast Track designation is granted for a medicine that is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. AD, also known as atopic eczema, is a chronic inflammatory skin disorder caused by skin barrier dysfunction and dysregulation of the immune response.

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Trials Dermatology Bioavailability Medicine 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. Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.(2-5) About Severe Asthma. Priority Review.

Allergies 52

Allergies Trials In-Vivo Medicine 52