pharmaphorum

APRIL 26, 2022

As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval.

Containment 101

Containment Production Development Immune Response 101

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. GAITHERSBURG, Md., Source link.

Vaccination 52

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

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. Forward-Looking Statements.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Delveinsight

DECEMBER 13, 2020

alcohol, certain drugs) and autoimmune diseases can also cause hepatitis. The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). 2b) was developed to maintain a steady level of an active drug and reduce the frequency of administration.

Genotype 52

Genotype FDA Approval DNA Drugs 52

XTalks

AUGUST 17, 2020

chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. Immune system modulators (i.e. protein-based biologics) and vaccine treatments.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. Director of the FDA’s Center for Biologics Evaluation and Research.

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

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

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

Drug Discovery World

MAY 29, 2024

Affordability and accessibility Of the more recently approved CGTs that are available to patients, approximately a third of the cost of those drugs is due to purification alone. The packed capsids are the ones you really want, as they contain the genetic information that’s going to be transferred to the host”, he says.

Gene Therapy 109

Gene Therapy Gene Genetics DNA 109

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., The information contained in this release is as of December 10, 2020. Bahrain, and Canada. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

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. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 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

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. INTERCHANGEABILITY. Pfizer Disclosure Notice.

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Vaccination Vaccine Protein Immune Response 111

The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . Regeneron has shared these results with the U.S. combined dose groups; 6.5%

Antibody 40

Antibody Trials Production Clinical Trials 40

Drug Discovery World

MAY 11, 2023

If they are not detected and removed during purification, process-related impurities can alter drug quality or evoke undesired immunogenic reactions in the patient. Another dangerous consequence can occur when the therapeutic or vaccine introduces proteins that can activate an uncontrolled immune response.

Production 52

Production Gene Protein Vaccination 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). CULVER CITY, Calif.–(

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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 The information contained in this release is as of July 19, 2022. INTERCHANGEABILITY.

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. 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.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. This indication is approved under accelerated approval based on tumor response rate and durability of response.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

The Pharma Data

AUGUST 17, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Immune Response 52

Immune Response Trials Medicine FDA Approval 52

pharmaphorum

NOVEMBER 2, 2021

The more targeted, bispecific functionality of bsAbs broadens the reach of antibody-mediated therapies against both solid and haematological cancers, creating novel approaches that can induce a tumour-specific immune response, target immune checkpoints, or improve payload delivery to tumour cells (Fig.

Antibody 52

Antibody Immune Response Production Engineer 52

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). 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

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. chief medical officer and head of Global Product Development.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

JUNE 30, 2021

The Marketing Authorization approves use of Opdivo plus Yervoy in all EU member states, as well as Norway, Iceland and Liechtenstein. Opdivo plus Yervoy received approval from the U.S. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials 52

Trials Genome Genomics Containment 52

The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (FDA). 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

JULY 23, 2021

Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. In consultation with the U.S. About Opdivo.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Vaccination 52

Vaccination Vaccine Trials Containment 52

The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. Immune-Mediated Endocrinopathies. About Opdivo.

Trials 52

Trials Hormones Genome Genomics 52

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. At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma.

Sales 52

Sales Vaccination Vaccine Medicine 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. . INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98