Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. Reduction in these two biomarkers in response to tofersen is believed to predict clinical benefit for patients. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

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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Drugs FDA Approval Sales Vaccination 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax.

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XTalks

AUGUST 17, 2020

chimeric receptor antigen [CAR] T cell) immune modulators (i.e. protein-based biologics) and vaccine treatments. 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.

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Protein Engineer Immune Response In-Vivo 98

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death.

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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. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Source: Novavax, Inc. .

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The award is funding the U.S. Source link.

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Clinical Development Vaccination Vaccine Development 52

The Pharma Data

FEBRUARY 23, 2022

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. for efficacy, immunogenicity and safety compared to a placebo. 1.351 (Beta) variant.

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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.

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Vaccination Vaccine Immune Response Protein 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The F-protein facilitates the fusion of the virus with the membrane of the host cell. billion by 2028.

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Vaccination Vaccine FDA Approval Protein 98

Pharmaceutical Technology

OCTOBER 25, 2022

A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins. Imjudo is also a human monoclonal antibody and hinders cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) activity.

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Immune Response Protein FDA Approval Antibody 173

Find Me Cure

OCTOBER 13, 2019

HER2 is a protein that plays an important role in cancer cell growth and is found on the surface of cancer cells in a very high quantity in about 10-20% of breast cancers. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

Development 52

Development DNA Clinical Trials Clinical Trials 52

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.

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Genotype FDA Approval DNA Drugs 52

STAT News

MARCH 6, 2023

Neoantigen vaccines are designed to target certain proteins called neoantigens on tumor cells. “The biology is pretty solid,” Wu said in a Globe interview, although she estimated that the treatment is still one to five years from FDA approval.

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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

DECEMBER 18, 2020

The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Director of the FDA’s Center for Biologics Evaluation and Research. Director of the FDA’s Center for Biologics Evaluation and Research.

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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). Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

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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.

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XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. It’s caused by mutations in the DMD gene, which encodes the dystrophin protein; dystrophin plays an important role in supporting muscle fibers.

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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.

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Production Gene Protein Vaccination 52

Drug Discovery World

APRIL 14, 2023

Jaffee’s award lecture will be held on Monday April 17 at 4:45pm ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET. Schreiber’s award lecture will be held on Monday April 17 at 5:30pm ET.

Genetics 52

Genetics Research Medicine Clinical Research 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., Casirivimab and imdevimab injection is not FDA approved for any use. did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk.

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.

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XTalks

DECEMBER 17, 2021

While researchers are still learning more about Omicron, what we know is that it has the ability to spread quickly, has over 30 mutations in its spike protein and can impact the effectiveness of current vaccines. The results are promising and Moderna is set to go ahead with its planned Phase II trial for the vaccine.

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Drug Discovery World

AUGUST 21, 2023

Combination therapy with pembrolizumab In July 2021, the Food and Drug Administration (FDA) approved Merck’s pembrolizumab (Keytruda) for high-risk, early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. and 79.6%, respectively.

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Protein Trials Clinical Trials Clinical Trials 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

The Pharma Data

DECEMBER 31, 2020

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. The partial piece of the spike protein cannot cause COVID-19 disease.

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FDA Approval Vaccination Vaccine Hormones 52

The Pharma Data

MARCH 16, 2021

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases.

Medicine 52

Medicine Doctors Doctor Development 52

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Saphnelo is also being evaluated for SLE in the European Union and Japan.

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Marketing Sales FDA Approval Antibody 52

Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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RNA Drugs Gene Silencing Vaccination 52

XTalks

JUNE 9, 2022

It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Evkeeza works by binding to and blocking the function of ANGPTL3, which is a protein that plays a role in lipid metabolism.

Trials 52

Trials Antibody Genetics Gene 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.

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