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.

Immune Response 62

Immune Response Vaccination Vaccine Gene Sequencing 62

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

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.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

XTalks

NOVEMBER 20, 2020

Meanwhile, Indoor Biotechnologies has been working with Cardiff University’s School of Medicine on its test. Traditional antibody tests for uncovering past infections involve detection of antigen-specific antibodies produced during an immune response against a pathogen. The Adaptive Immune System and TCRs.

Antibody 98

Antibody Immune Response Protein In-Vitro 98

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.

Vaccination 52

Vaccination Vaccine Immune Response Nurses 52

pharmaphorum

DECEMBER 15, 2020

When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains resistant to existing antibacterial medicines. But there have been no GBS vaccines licensed since then, the Lancet pointed out in an editorial earlier this year.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 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

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

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization . has a fever.

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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 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

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 Vaccination Vaccine 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

Drug Discovery World

MARCH 24, 2023

dendritic cells, monocytes) triggers a broad immune response that includes significant increases in cytotoxic CD8 plus T cells armed with chemo-induced tumour antigens to target cancer. This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month

Trials 52

Trials Immune Response HR Clinical Development 52

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

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

Vaccination 52

Vaccination Vaccine Immune Response Licensing 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

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 52

Immune Response Sales Antibody Pharma Companies 52

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.

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Vaccination Vaccine Contract Manufacturing Production 52

The Pharma Data

JULY 11, 2021

Phase 3 study met primary and secondary endpoints demonstrating MenQuadfi ® induced superior immune responses to serogroup C compared to a standard-of-care vaccine in healthy toddlers MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers.

Immune Response 52

Immune Response Vaccination Vaccine Licensing 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

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Dermatology 40

Dermatology Trials Bioavailability Medicine 40

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 81

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

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 Vaccination Vaccine Clinical Trials 102

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

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

APRIL 20, 2023

SARS-CoV-2 particles spread through the respiratory mucosa and other infected cells, causing changes in peripheral immune cells and eliciting a cascade of immune responses, resulting in a detrimental cytokine storm. EJ Goetzl and D Kapogiannis, “Long-COVID: Phase 2 of the COVID-19 Pandemic,” American Journal of Medicine, vol.

Development 98

Development Drugs Clinical Trials Clinical Trials 98

Pfizer

OCTOBER 20, 2022

On February 15, 2022, Pfizer announced the European Medicines Agency (EMA) approved the company’s 20-valent pneumococcal conjugate vaccine, which is marketed in the European Union (EU) under the brand name APEXXNAR. . Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 09.28.2022.

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Vaccination Vaccine Containment Immune Response 40

Drug Discovery World

SEPTEMBER 6, 2022

This area of medicine, which turns our own bodies into agents of combat to fight disease, has quickly become one of the most promising fields in treating deadly diseases such as cancer, central nervous system disorders and even musculoskeletal conditions. . billion, compared to $19.9 million price point per dose. Cancer is king .

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

The primary endpoints of the study include safety and overall response rate, while secondary endpoints include progression-free survival, overall survival and immune response correlates. SELLAS’ lead product candidate, GPS, is licensed from MSK and targets the WT1 protein, which is present in an array of tumor types.

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

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

MAY 6, 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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Delveinsight

DECEMBER 3, 2020

AMD Patients often have low levels of CD59, which is a protein that protects the retina from damage caused by a vital part of the body’s natural immune response called complement. Bayer has made a cell and gene therapy platform to assist its growing pipeline of advanced therapy medicinal products.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

The Pharma Data

JULY 21, 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. Procedures should be in place to avoid injury from fainting.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52