FDA Approval, Immune Response and Licensing - Clinical Research Informer

U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

FDA Approval

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Licensing

Licensing Licensing Vaccination Vaccine

Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

OCTOBER 28, 2022

What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending.

Vaccination

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing

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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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. At six months, 29.5

Vaccination

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Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. The treatment requires three initial doses at 14-day intervals, followed by a maintenance dose every 28 days. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

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PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

AUGUST 16, 2021

Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. In 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). News information is not all-inclusive and updates are published once a week on Tuesdays. . . Other Industry News.

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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. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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Moderna ramps up EU COVID jab capacity via Lonza deal

pharmaphorum

JUNE 2, 2021

The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals.

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U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccination

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Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

Vaccination

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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

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. Casirivimab and imdevimab injection is not FDA approved for any use.

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Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Antibody

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. “The investigational cocktail is now available to indicated high-risk U.S.

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Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Germany, Turkey, South Africa, Brazil and Argentina. Source: Pfizer Inc. .

Vaccination

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. Nizoral is prescribed off-label, while the others are FDA approved. What Is a Surrogate Endpoint? Novartis’ Signifor (pasireotide) is also indicated in the treatment of the disease.

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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

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

Vaccination

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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

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. INTERCHANGEABILITY.

Vaccination

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody

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Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody

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Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

Pfizer

OCTOBER 20, 2022

Food and Drug Administration (FDA) approved PREVNAR 20® for the prevention of invasive disease and pneumonia in adults age 18 years or older. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay.

Vaccination

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Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

In September, Corbus Pharmaceuticals Holdings announced topline results from its 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc), a rare life-threatening multi-system autoimmune disease for which there are no FDA-approved treatments.

Clinical Trials

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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 the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. The new development program builds on the companies’ success in developing the first approved and most widely used mRNA vaccine as of today i to help prevent COVID-19. INDICATION.

Vaccination

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Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

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Clinical Research Informer

U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Trending Sources

Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

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

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

Biopharma Update on the Novel Coronavirus: October 27

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

Moderna ramps up EU COVID jab capacity via Lonza deal

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

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

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

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

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

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

Advances in the Battle Against Autoimmune Disease

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 Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

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