The Pharma Data

FEBRUARY 12, 2022

Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Food and Drug Administration. patients who recovered from COVID-19.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

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The Pharma Data

FEBRUARY 13, 2022

About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. If approved, Dupixent will be the first biologic medicine available in the U.S.

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The Pharma Data

APRIL 16, 2021

Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone.

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The Pharma Data

APRIL 4, 2022

Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. If approved, Dupixent would be the first medicine available in the U.S.

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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.

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The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). However, polyps have a strong tendency to reoccur often leading to repeat surgery.

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The Pharma Data

MAY 4, 2021

Serious Side Effects : Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

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Drug Discovery World

OCTOBER 28, 2022

A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the Epstein-Barr virus (EBV) have been shown to block infection when tested in human cells in a laboratory setting. . There is no licensed vaccine to protect against the virus. . EBV is one of the most common human viruses.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.

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Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Kielczewska will present: ‘Discovery of antibody-based therapeutics to challenging targets: Platform considerations’.

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Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. GMTs) in an earlier analysis. have a fever.

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Pfizer

JULY 26, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The booster schedule is based on the labeling information of the vaccine used for the primary series.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

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Drug Discovery World

FEBRUARY 20, 2023

At the start of the year, a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID) proved that an additional dose of a Covid-19 vaccine is safe in adults who had previously received a full regimen of an approved vaccine.

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Pfizer

DECEMBER 8, 2022

Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. EMERGENCY USE AUTHORIZATION.

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Pfizer

SEPTEMBER 28, 2022

Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). 5-adapted bivalent vaccine.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA).

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Pfizer

JULY 19, 2022

Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency. Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. Emergency Use Authorization. has a fever.

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Pfizer

SEPTEMBER 16, 2022

The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against both Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. EMERGENCY USE AUTHORIZATION.

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Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17. Pfizer and BioNTech submitted the same data to the U.S. The companies also plan to submit these data to other regulatory agencies around the world. . has a fever.

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Pfizer

NOVEMBER 2, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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Pfizer

OCTOBER 19, 2022

Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. EMERGENCY USE AUTHORIZATION. have a fever.

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The Pharma Data

JANUARY 24, 2021

It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. All participants randomized to receive either 4,200 mg of bamlanivimab, Lilly’s neutralizing antibody, or placebo.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 1) The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022. US Food and Drug Administration. Reese, M.D.,

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Food and Drug Administration for the products. 2018 for patients with severe asthma, without an eosinophilic phenotype.

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The Pharma Data

APRIL 8, 2021

The COV-BARRIER trial was designed to complement the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Food and Drug Administration (FDA) on Nov. An emergency use authorization (EUA) was issued by the U.S.

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen will record sales in the U.S.

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The Pharma Data

FEBRUARY 8, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million.

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The Pharma Data

FEBRUARY 4, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million.

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The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category.

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly Antibody Therapies Around the World. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.

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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). Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.

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