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. US marketing application.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

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 52

Vaccination Vaccine Immune Response Antibody 52

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. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

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 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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 .

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

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 52

Vaccination Vaccine FDA Approval Containment 52

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.

Antibody 52

Antibody Trials Production Clinical Trials 52

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 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 10, 2020

BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., 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. Bahrain, and Canada.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

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.

Antibody 52

Antibody Medicine Production Trials 52

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 100

Vaccination Vaccine Medicine Clinical Trials 100

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 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

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. The marketing rights to Thiola were acquired by Retrophin in 2014 from Mission Pharmacol. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

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 52

Antibody Production Clinical Trials Clinical Trials 52

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 40

Vaccination Vaccine Containment Immune Response 40

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 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 15, 2020

In November , the European Medicines Agency agreed to review the Marketing Authorization Application for avacopan for the treatment of patients with ANCA-associated vasculitis. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems. Oral, Small Molecules.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Europe, generic competition has started in certain countries after the expiration of Jevtana ® ’s market exclusivity in March 2021. Change at CER.

Sales 52

Sales Vaccination Vaccine Medicine 52

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 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

FEBRUARY 24, 2022

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. No new safety concerns were identified from the data available.

Vaccination 52

Vaccination Vaccine Production Immune Response 52