Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech Procedures should be in place to avoid injury from fainting. BioNTech COVID-19 Vaccine.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. About Pneumococcal Disease.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 11, 2021

Using its novel yeast display system and large diverse human antibody libraries, AvantGen has identified a panel of high affinity human monoclonal antibody clones that bind to two distinct epitopes on the receptor binding domain of the SARS-CoV-2 spike protein. IGM Cautionary Note Regarding Forward-Looking Statements.

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. 74% had measurable cellular responses at the 1.0 mg dose group demonstrated cellular responses. . PLYMOUTH MEETING, Pa. , The 1.0 mg and 2.0 mg dose group.

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DNA Vaccination Vaccine Immune Response 40

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).

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. Basel, 18 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. This is the focus of vaccines in development and convalescent plasma therapy.

Antibody 52

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Delveinsight

DECEMBER 13, 2020

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. in January 2019.

Genotype 52

Genotype FDA Approval DNA Drugs 52

The Pharma Data

JANUARY 24, 2021

In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines.

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Development Vaccination Vaccine Production 52

The Pharma Data

SEPTEMBER 8, 2020

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Sanofi, Empowering Life. For further information, please visit www.sanofi.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

OCTOBER 21, 2020

Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released.

Gene Therapy 40

Gene Therapy Immune Response Sales Gene 40

The Pharma Data

SEPTEMBER 8, 2020

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. This press release contains “forward-looking statements” of. Every day, Pfizer. Empowering Life. www.sanofi.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

Production 52

Production Gene Protein Vaccination 52

pharmaphorum

AUGUST 13, 2020

One Pfizer brand getting plenty of attention is Xeljanz, their blockbuster anti-JAK rheumatoid arthritis pill that could damp down the massive immune response that overwhelms some COVID-19 patients. Kaletra (also known as Aluvia) contains anti-viral components that block virus replication. AbbVie has donated $1.5

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Branding Vaccination Vaccine Filler 112

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 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., did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk. futility analysis). .

Antibody 52

Antibody Trials Production Clinical Trials 52

Drug Discovery World

OCTOBER 12, 2022

Professor Michael Butler, head of the National Institute for Bioprocessing Research and Training (NIBRT) Cell Technology Group (CTG), explains that the characterisation and analysis of glycans is important for the biopharma sector as it can help in the development of therapeutic agents such as monoclonal antibodies and other recombinant proteins.

Protein 52

Protein Gene Therapy Antibody Production 52

Pharmaceutical Technology

AUGUST 24, 2022

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1%

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Clinical Trials Clinical Trials Trials Development 130

The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

Antibody 52

Antibody Sales Production Development 52

The Pharma Data

DECEMBER 17, 2020

To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Antibody 52

Antibody Medicine Production Trials 52

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.

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Vaccination Vaccine Containment Immune Response 40

The Pharma Data

JUNE 18, 2021

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]). pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses.

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Vaccination Vaccine FDA Approval Containment 52

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). The BiTE platform is an innovative technology designed to engage the immune system against numerous stages and types of cancers.

Antibody 52

Antibody Immune Response Production Engineer 52

The Pharma Data

NOVEMBER 23, 2020

It is an mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. It contains the genetic materials of the spike protein. Type: Adenovirus-based.

Vaccination 52

Vaccination Vaccine Protein Trials 52

The Pharma Data

JUNE 29, 2021

A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. There is an excellent response to a second dose, even after a 10 month delay from the first.”.

Immune Response 52

Immune Response Vaccination Vaccine Antibody 52

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

The Pharma Data

SEPTEMBER 15, 2020

20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

Drug Discovery World

OCTOBER 21, 2022

Simultaneously, the capacity to conjugate fluorescent molecules to proteins to better characterise biological systems has evolved accordingly, enabling the proliferation of highly specific tools to interrogate cells. Setting up proper single-colour controls is critical to obtaining good compensation and spectral unmixing matrices.

Reagent 52

Reagent Antibody Drugs Protein 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. Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors.

Trials 52

Trials Genome Genomics Containment 52

The Pharma Data

DECEMBER 20, 2020

It is an optimized, non-chemically modified mRNA that codes for the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany.

Trials 52

Trials Gene Therapy Vaccination Vaccine 52

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

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. Conclusions. Transgene has an ongoing Invir.IO collaboration with AstraZeneca. Disclaimer.

Vaccination 52

Vaccination Vaccine Trials Containment 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 Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

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. to €127 million.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 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

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 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