XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

The Pharma Data

DECEMBER 18, 2020

ACAAI: Reaction to COVID-19 Vaccine Unlikely for Those With Common Allergies. The ACAAI COVID-19 Vaccine Task Force issued the guidance related to the risk for an allergic reaction with the Pfizer-BioNTech COVID-19 vaccine that was given emergency use authorization by the U.S. Food and Drug Administration on Dec.

Allergies 52

Allergies Vaccination Vaccine Immune Response 52

XTalks

AUGUST 16, 2021

The US Food and Drug Administration (FDA) has amended its emergency use authorizations (EUA) for both the Pfizer and Moderna COVID-19 vaccines to incorporate a third dose for immunocompromised individuals. The allowance of a booster dose only applies to immunocompromised individuals. According to the CDC, approximately 2.7

Vaccination 104

Vaccination Vaccine Antibody Immune Response 104

XTalks

FEBRUARY 24, 2025

Carlsbad, California-based Ionis Pharmaceuticals announced it will be sharing promising new trial data for its RNA-targeted prophylactic treatment donidalorsen for hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California.

Trials 59

Trials RNA Allergies Drugs 59

XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

Manufacturing 83

Manufacturing Vaccination Vaccine Allergies 83

XTalks

NOVEMBER 16, 2020

Moderna announced today that its highly anticipated COVID-19 vaccine candidate appears to be 94.5 The news comes shortly after Pfizer and BioNTech’s mega announcement last week of their COVID-19 vaccine having shown 90 percent efficacy in an ongoing large-scale Phase III trial. The vaccine is given in two doses.

Vaccination 105

Vaccination Vaccine Trials Allergies 105

XTalks

MAY 11, 2022

The US Food and Drug Administration (FDA) announced last week that it has limited the authorized use of Janssen/Johnson & Johnson’s COVID-19 vaccine for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible or clinically appropriate.

Vaccination 98

Vaccination Vaccine Sales Allergies 98

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

XTalks

OCTOBER 26, 2023

The best way to prevent the flu is by getting vaccinated every year. The CDC and the World Health Organization (WHO) recommend annual flu vaccination for most people, especially those at high risk of serious complications, like pregnant women, elderly individuals, children and people with certain chronic health conditions.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

Cosmetics 130

Cosmetics Allergies Manufacturing Production 130

NY Times

MARCH 23, 2021

According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated information.”.

Vaccination 140

Vaccination Vaccine Trials Clinical Trials 140

Delveinsight

AUGUST 6, 2020

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. Zydus has only said that the vaccine was well tolerated by people who received it in the first phase of the trial.

Allergies 53

Allergies Vaccination Vaccine Gene Therapy 53

NY Times

NOVEMBER 30, 2020

The first shots could be given as early as Dec. 21, if authorization is granted.

Vaccination 145

Vaccination Vaccine RNA Allergies 145

Scienmag

MAY 26, 2021

Meta-analysis updates findings about common vaccines A new study looking across a large body of research finds further evidence for the safety of vaccines that are Food and Drug Administration-approved and routinely recommended for children, adults and pregnant women.

Vaccination 75

Vaccination Vaccine Drugs Research 75

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

JANUARY 6, 2021

6, 2021 — Cases of anaphylactic shock caused by COVID-19 vaccines are very rare, based on numbers from the first week and a half of vaccinations in the United States, federal public health officials said Wednesday. Seven out of 10 cases occurred within 15 minutes of vaccination. WEDNESDAY, Jan.

Vaccination 52

Vaccination Vaccine Allergies Drugs 52

The Pharma Data

DECEMBER 22, 2020

22, 2020 — In very rare cases, some people have had severe allergic reactions after receiving the new COVID-19 vaccines, leading the American College of Allergy , Asthma, and Immunology (ACAAI) to issue updated guidance for Americans with allergies. TUESDAY, Dec. © 2020 HealthDay. All rights reserved. Source link.

Vaccination 52

Vaccination Vaccine Allergies Immune Response 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

SEPTEMBER 28, 2022

5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. 5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age. 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

XTalks

DECEMBER 7, 2020

Past Few Weeks Herald Good News on the Vaccine Front. First came the news from Pfizer and its German partner BioNTech that their mRNA vaccine was 90 percent effective in preventing symptomatic COVID-19 disease. In their trial, some 30,000 patients received either two doses of Moderna’s mRNA-1273 vaccine 28 days apart or placebo.

Vaccination 52

Vaccination Vaccine Development Drugs 52

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

DECEMBER 17, 2020

Advisory Committee Votes to Recommend EUA for Moderna Vaccine. 17, 2020 — The Moderna COVID-19 vaccine received recommendation from a U.S. Food and Drug Administration advisory committee on Thursday, clearing the way for it to become the second COVID-19 vaccine to be granted emergency use authorization.

Vaccination 52

Vaccination Vaccine Allergies Clinical Trials 52

Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JANUARY 21, 2021

21, 2021 — Despite scattered media reports of severe allergic reactions to the Pfizer COVID-19 vaccine, a detailed analysis shows that such incidents are very rare, striking just 11 people for every million doses given. Tom Shimabukuro tracked data on reactions to the Pfizer vaccine soon after it was approved in December.

Vaccination 52

Vaccination Vaccine Allergies Research 52

pharmaphorum

NOVEMBER 30, 2020

Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results for the shot. It also appears to prevent volunteers from getting very sick from the virus, as all 30 cases of severe COVID-19, and single coronavirus-related death, were in the placebo arm.

Vaccination 59

Vaccination Vaccine Allergies Marketing 59

Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

Research 112

Research Vaccination Vaccine Drugs 112

Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Roots Analysis

MARCH 16, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is worth noting that several companies have begun to develop mRNA-based cancer immunotherapies and vaccines for infectious diseases.

Vaccination 52

Vaccination Vaccine DNA Protein 52

The Pharma Data

JANUARY 7, 2021

Anaphylaxis Cases/Million Doses of Pfizer-BioNTech COVID-19 Vaccine Reported. per million doses administered) after receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine in the United States, according to research published in the Jan. percent) adverse events submitted to the Vaccine Adverse Event Reporting System (VAERS).

Vaccination 52

Vaccination Vaccine Allergies Research 52

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added. .

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JULY 12, 2021

Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. What Is the Janssen COVID-19 Vaccine?

Vaccination 52

Vaccination Vaccine FDA Approval Allergies 52

pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Development in peanut allergy has also been discontinued, said Sanofi in its second-quarter update.

Drugs 69

Drugs Immune Response Allergies Sales 69

The Pharma Data

MARCH 2, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

MAY 11, 2022

The spread of drug-resistant pathogens poses a serious problem to treat common infections. Outterson outlined the actions that are needed in the short-term to counter AMR: “First, stop wasting these drugs. Second, prevent infections wherever possible, including with vaccines. Why AMR is a threat. That is our mission at CARB-X.”.

Bacteria 145

Bacteria Development Vaccination Vaccine 145