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

XTalks

DECEMBER 29, 2023

Classified as a bispecific T-cell engager (BiTE molecule), tarlatamab consists of two essential parts: one binds to T-cells, vital in immune response, and the other targets cancer cells. Tarlatamab differs from conventional chemotherapy as it’s an immunotherapy designed to help immune cells detect, attach to and fight cancer cells.

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Clinical Trials Clinical Trials FDA Approval Trials 119

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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Manufacturing Vaccination Vaccine RNA 130

XTalks

SEPTEMBER 25, 2024

The candidate, MPV/S-2P, uses a murine pneumonia virus to deliver the stabilized spike protein, aiming to activate immunity both in the blood and in the respiratory tract’s mucosal tissues — where many respiratory viruses take hold.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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FDA Approval Gene Therapy Gene Clinical Trials 111

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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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

JUNE 15, 2022

The Novavax COVID-19 vaccine was recommended for emergency use in adults by the World Health Organization (WHO) in December 2021 , and is approved in over 40 countries. The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. The Novavax COVID-19 Vaccine Candidate.

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Vaccine Vaccination Immune Response Protein 59

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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FDA Approval Manufacturing In-Vivo Trials 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

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.

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Immune Response Vaccination Vaccine FDA Approval 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.

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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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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

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

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

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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Vaccination Vaccine FDA Approval Hormones 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.

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Vaccination Vaccine Immune Response Protein 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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Vaccine Vaccination Antibody Protein 52

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.

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Development DNA Clinical Trials Clinical Trials 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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XTalks

MAY 24, 2024

Tarlatamab Clinical Trial Insights In the DeLLphi-301 Phase II study, tarlatamb was administered biweekly at a dose of 10 mg to patients with advanced SCLC who had progressed after two or more prior lines of therapy, aiming to activate their immune responses against the tumor. About 40 percent of patients saw significant shrinkage.

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Antibody Clinical Trials Clinical Trials Trials 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.

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Trials Antibody Genetics Gene 52

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 Vaccination Vaccine 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

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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Trials Gene Hormones Clinical Trials 98

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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Antibody Immune Response Production Engineer 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

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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The Pharma Data

JULY 6, 2021

Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. There are currently no FDA-approved treatment options for FTD. About the Progranulin-Elevating Monoclonal Antibodies – AL001 and AL101.

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Genetics Gene Antibody Development 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).

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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. INDICATION.

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Vaccine Vaccination Clinical Trials Clinical Trials 85

Pfizer

OCTOBER 20, 2022

PREVNAR 20® is Pfizer’s next-generation pneumococcal conjugate vaccine that 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 CRM197 Protein]). On June 8, 2021, Pfizer announced 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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Life Science Vaccine Vaccination Trials 98

The Pharma Data

JUNE 30, 2021

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. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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Trials Genomics Genome Containment 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. Source: Regeneron. Posted: November 2020.

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