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

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

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

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

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

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. “For

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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

The Pharma Data

DECEMBER 23, 2020

company developing UB-612 a multitope peptide-based vaccine to fight COVID-19, today announced an exclusive agreement with Aurobindo Pharma to expand its global development and commercialization of UB-612 to India and the United Nations Children’s Fund (UNICEF) agency. billion, to deliver the vaccine in multiple countries.

Vaccination 52

Vaccination Vaccine Manufacturing Antibody 52

The Pharma Data

JANUARY 27, 2021

coronavirus vaccination effort, the White House COVID-19 Response team announced Wednesday. Department of Health and Human Services (HHS) is amending its rules to allow retired health professionals to administer COVID-19 vaccine shots, said Jeff Zients, the White House COVID-19 Response coordinator. WEDNESDAY, Jan.

Nurses 52

Nurses Doctors Doctor Vaccination 52

The Pharma Data

DECEMBER 2, 2020

Yet, despite the push, the UK is set to administer the first Western vaccine before the FDA’s vaccine review committee even meets, leaving an increasingly skeptical public wondering why. For the COVID-19 vaccines, Pfizer and Moderna are still collecting data from Phases I and II. Most vaccines take 20 to 30 years to be licensed.

Vaccination 52

Vaccination Vaccine Trials Licensing 52

Scienmag

DECEMBER 17, 2020

December 17, 2020 — An opinion piece published today online in BMJ by Nina Schwalbe in the Heilbrunn Department of Population and Family Health at Columbia Mailman School of Public Health, calls for a national vaccine strategy now that COVID-19 vaccines are available.

Vaccination 40

Vaccination Vaccine Licensing Licensing 40

The Pharma Data

MAY 8, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., The vaccine showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. 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 147

FDA Approval Antibody Allergies Packaging 147

The Pharma Data

DECEMBER 23, 2020

24, 2020 /PRNewswire/ — COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .

Vaccination 52

Vaccination Vaccine Development Manufacturing 52

The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. The MOH has secured 6 million doses of the COVID-19 Vaccine Moderna.

Vaccination 52

Vaccination Vaccine Medicine Containment 52

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

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

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

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 52

Vaccination Vaccine Medicine Clinical Trials 52

Pfizer

SEPTEMBER 16, 2022

1 bivalent vaccines. The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

Drug Discovery World

OCTOBER 28, 2022

Scientists from the National Institute of Allergy and Infectious Diseases (NIAID) in collaboration with researchers from Walter Reed Army Institute of Research, led the study. . There is no licensed vaccine to protect against the virus. . EBV is one of the most common human viruses.

Antibody 52

Antibody Allergies Protein Licensing 52

XTalks

MAY 2, 2024

Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. The condition is an adverse event linked to competitor vaccines.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , The participants were enrolled into 1.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

OCTOBER 26, 2020

Testing Therapies, Antivirals and Vaccines. Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K. Days after the U.S.

Antibody 52

Antibody Vaccination Vaccine Manufacturing 52

Pfizer

OCTOBER 19, 2022

In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 5-adapted bivalent COVID-19 vaccine for use in children under 5 years of age. 5-adapted bivalent COVID-19 vaccine across age groups. . AUTHORIZED USE.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

Delveinsight

JANUARY 21, 2021

Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. Gritstone appends COVID-19 to the pipeline with the NIAID-supported vaccine. Like the first generation of COVID-19 vaccines , the candidate of Gritstone aims the spike protein of the new coronavirus.

Research 52

Research Protein Clinical Trials Clinical Trials 52

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer In April, Biotech ISA Pharmaceuticals launched a clinical trial using its Amplivant adjuvant technology to test Scancell’s Modi-1 vaccine in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. The candidate demonstrated 64.7%

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 30, 2022

The debut was the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014, and followed a £195 million fundraising round for Oxford Nanopore in May. The Oxford University spin-out rose to prominence for commercialising the technology platform behind the Oxford/AstraZeneca COVID-19 vaccine.

Life Science 95

Life Science Allergies DNA Licensing 95

pharmaphorum

OCTOBER 1, 2021

It also won a £113 million contract to provide rapid saliva-based COVID-19 testing services to the NHS, although that was ended early by the UK government in the summer as demand fell due to vaccinations. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

Marketing 52

Marketing Business Development Genome Genomics 52

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 52

Sales Vaccination Vaccine Medicine 52

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. for a pediatric dose.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

FEBRUARY 8, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

FEBRUARY 4, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

JANUARY 24, 2021

Gritstone Oncology , based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug was licensed from Immutep Limited. COVID-19-Related.

Trials 52

Trials Allergies In-Vitro Antibody 52

The Pharma Data

APRIL 4, 2022

We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. If approved, Dupixent would be the first medicine available in the U.S. Source link: [link].

Medicine 52

Medicine Trials Allergies FDA Approval 52

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. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Additional safety information can be viewed below.

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

FEBRUARY 12, 2022

Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bebtelovimab is being studied for the treatment of mild-to-moderate COVID-19 both as a monotherapy and together with other mAbs.

Antibody 40

Antibody Trials Clinical Trials Clinical Trials 40

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 52

FDA Approval Clinical Trials Clinical Trials Trials 52