XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Reduction in these two biomarkers in response to tofersen is believed to predict clinical benefit for patients. What is SOD1 -ALS?

FDA Approval 89

FDA Approval Gene Genetics Protein 89

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. . ” Findings from the Phase 1 Clinical Trial.

DNA 40

DNA Vaccination Vaccine Immune Response 40

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. MicroRNAs are smaller than the small interfering RNA (siRNA) drugs now reaching the market, such as Alnylam’s Onpattro (patisiran), Givlaari (givosiran) and Oxlumo (lumasiran) for rare diseases.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8%

Drugs 59

Drugs Life Science Gene Editing Gene 59

pharmaphorum

DECEMBER 1, 2021

In a complete response letter (CRL), the FDA said that it would need a second clinical trial of plinabulin before it could consider approving the drug, setting up what looks like a lengthy delay for the programme. The post BeyondSpring faces a tough winter as FDA rejects its lead drug appeared first on.

Drugs 52

Drugs Immune Response Trials Licensing 52

The Pharma Data

AUGUST 16, 2021

Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. In the U.S.,

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. 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.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

pharmaphorum

AUGUST 27, 2020

The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. In the UK, structural problems of the AIM market have compounded these problems by driving institutional investors away from relatively illiquid shares. Companies have struggled to access intermediate capital. COVID-19 sparks change.

Vaccination 112

Vaccination Vaccine Life Science Clinical Trials 112

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., month median overall survival (mOS) improvement, statistically significant mOS improvements between 4.2

Trials 52

Trials Immune Response HR Clinical Development 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S., About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S.,

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52

The Pharma Data

MAY 6, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

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. Alzheimer’s disease), or by initiating a new one. Treherne is currently Chairperson of Monument Therapeutics.

Development 98

Development Drugs Clinical Trials Clinical Trials 98

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

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. in the U.S.) The Pfizer?BioNTech

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

APRIL 2, 2021

Pfizer’s newest and updated COVID-19 vaccine trial results from its ongoing Phase III clinical trial confirms that protection lasts at least six months after administration of the second dose. 1.351 variant, which may have the potential to evade the immune response.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic. Download this exclusive report here.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the BNT162 Vaccine Candidate Program. billion doses by the end of 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 23, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Vaccination 52

Vaccination Vaccine Immune Response Production 52

The Pharma Data

DECEMBER 10, 2020

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. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

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 .

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

AUGUST 20, 2020

The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. This press release features multimedia. View the full release here: [link].

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Every day, Pfizer.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Pharmaceutical Technology

AUGUST 12, 2022

The concept behind this form of treatment is that the introduction of these cells will enhance the immune response to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives. Overall, the global CAR-T cell market for all indications was worth $1.7

Development 130

Development Immune Response Drugs Marketing 130

Drug Discovery World

SEPTEMBER 6, 2022

And whilst clinical trials activity decreased by around 15% compared to 2020, last year still saw a number of regenerative medicines reach the bedside. The challenge for the market then, according to Boissel, is how much can a payor afford to pay upfront? . billion, compared to $19.9 million price point per dose.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. The marketing rights to Thiola were acquired by Retrophin in 2014 from Mission Pharmacol.

Trials 98

Trials Gene Hormones Clinical Trials 98

Pfizer

JULY 8, 2022

In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. 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. Emergency Use Authorization.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

Antibody 52

Antibody Medicine Production Trials 52