The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S. In the U.S.,

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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.

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The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.

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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.

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Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

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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.

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The Pharma Data

JULY 29, 2021

professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center and co-principal investigator of COV-BARRIER. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Wesley Ely, M.D.,

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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.

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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.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Ricks , Lilly chairman and CEO. It is approved in the U.S. patients who recovered from COVID-19. .

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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.

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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)

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The Pharma Data

APRIL 14, 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. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

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The Pharma Data

APRIL 16, 2021

“Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19,” said Daniel Skovronsky, M.D., However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it.

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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.

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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?

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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.

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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. General Medicines core assets grew 4.4%, while GBU sales were down 3.8%. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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The Pharma Data

FEBRUARY 8, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. General Medicines declined 7.5%, reflecting lower U.S. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. Q4 2020 sales growth (2) of 4.2% and business EPS growth of 9.8%

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The Pharma Data

FEBRUARY 4, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. General Medicines declined 7.5%, reflecting lower U.S. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. Q4 2020 sales growth (2) of 4.2% and business EPS growth of 9.8%

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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.

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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.

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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.,

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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 .

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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.

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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. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. .

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The Pharma Data

NOVEMBER 9, 2020

” The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA).

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pharmaphorum

FEBRUARY 16, 2022

Innovative Licensing Access Pathway attracted a lot of interest in 2021, but not yet proven. January 2021 saw another effort to speed up access – this time with closer working between the MHRA and the UK’s HTA bodies, NICE and the SMC – the Innovative Licensing and Access Pathway (ILAP). It is however, a (refreshing?)

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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

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The Pharma Data

MARCH 5, 2021

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. patients who recovered from COVID-19.

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The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

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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.

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