Allergies, FDA Approval and Vaccination - Clinical Research Informer

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

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

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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

FDA Approval

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First Single-Shot Vaccine in Fight Against Global Pandemic

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.

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Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA, an agency within the U.S. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S.

FDA Approval

FDA Approval Genome Genomics Production

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

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. Pfizer and BioNTech Announce U.S.

FDA Approval

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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

The Pharma Data

JULY 29, 2021

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. Consider vaccination if medically appropriate.

FDA Approval

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Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 million doses of Moderna’s vaccine candidate against COVID-19 , mRNA-1273. “As

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Top Life Science News and Trends in 2023 at Xtalks

XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. Notably, pharmaceutical drugs dominated TV ad impressions this year, with an iSpot.tv billion ad impressions. billion in 2022.

Life Science

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Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

The Pharma Data

NOVEMBER 16, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Vaccination

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Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

FDA Actions. 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). Testing Therapies, Antivirals and Vaccines. Please read more here. . Days after the U.S.

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Extensive study identifies over a dozen existing drugs as potential COVID-19 therapies

Scienmag

JUNE 3, 2021

FDA-approved drugs or experimental drugs with ample health data could be rapidly tested in humans for treatment of COVID-19 Credit: Scripps Research June 3, 2021 – LA JOLLA, CA–Mining the world’s most comprehensive drug repurposing collection for COVID-19 therapies, scientists have identified 90 existing drugs or drug candidates with (..)

FDA Approval

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

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.

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Top 2020 Biopharma M&A Deals

The Pharma Data

DECEMBER 30, 2020

AstraZeneca Dives into Rare Diseases: AstraZeneca has been in the spotlight for the COVID-19 vaccine candidate it developed with Oxford University. Nestlé and Peanut Allergies – In August, Nestlé Health Science acquired the outstanding stakes of Aimmune for $2.6 But the U.K.-based Most Read Today. Source link.

Antibody

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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

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

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What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

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.

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Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

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

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FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

APRIL 4, 2022

Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Source link: [link].

Medicine

Medicine Trials Allergies FDA Approval

FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

Pharmaceutical Technology

JUNE 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

FDA Approval

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FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

The Pharma Data

JULY 29, 2021

Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity. Vaccinations: Avoid use of live vaccines with baricitinib. It is approved in the U.S.

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Update on ongoing Dupixent® (dupilumab) chronic spontaneous urticaria Phase 3 program

The Pharma Data

FEBRUARY 19, 2022

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Source link: [link].

Genetics

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FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

The Pharma Data

FEBRUARY 13, 2022

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Source link: [link].

Medicine

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Pfizer Responds to Research Claims

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

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Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. It is approved in the U.S. Ricks , Lilly chairman and CEO. See the full Prescribing Information here.

Antibody

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Johnson & Johnson Statement on COVID-19 Vaccine (7/12)

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

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. billion in 2022. billion in 2022.

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Monthly News Roundup – December 2020

The Pharma Data

DECEMBER 31, 2020

Moderna and Pfizer’s COVID-19 Vaccines Roll Out in Early Phase. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. In studies, the vaccines were found to be 94% to 95% effective in preventing COVID-19 disease.

Vaccination

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Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccination

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World RNA Day: What impact RNA it had on drug discovery?

Drug Discovery World

AUGUST 1, 2023

As reported by DDW , the aim for the centre is to help future-proof the UK against emerging health threats and the first mRNA vaccine is expected to be produced in the UK in 2025. This Phase I trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.

RNA

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Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Sales

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Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

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

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Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

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)

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AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab

pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab FDA Approval History. patients who recovered from COVID-19. . Posted: January 2021.

Antibody

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2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences

XTalks

DECEMBER 24, 2020

From isolating SARS-CoV-2 in early January to sequencing its genome shortly thereafter and having a prototype vaccine against it within days, scientific process and progress have held steadfast throughout the pandemic. For example, investment in mRNA vaccines and viral vectors came well before January, many years before it.

Life Science

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Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

The Pharma Data

JULY 15, 2021

Interim results from a Phase 1/2a sub-study published in the New England Journal of Medicine (NEJM) demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization, the length of time evaluated to date.

Immune Response

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Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Clinical Research Informer

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

Trending Sources

First Single-Shot Vaccine in Fight Against Global Pandemic

Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Top Life Science News and Trends in 2023 at Xtalks

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

Biopharma Update on the Novel Coronavirus: October 27

Extensive study identifies over a dozen existing drugs as potential COVID-19 therapies

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

Top 2020 Biopharma M&A Deals

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

Update on ongoing Dupixent® (dupilumab) chronic spontaneous urticaria Phase 3 program

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

Pfizer Responds to Research Claims

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

Johnson & Johnson Statement on COVID-19 Vaccine (7/12)

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Monthly News Roundup – December 2020

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

World RNA Day: What impact RNA it had on drug discovery?

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences

Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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