XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD).

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Life Science Drug Delivery Systems Vaccine Vaccination 52

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

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Moreover, 40-50% of patients experience recurrent disease requiring the need for cystectomy, which is associated with significant risks and bladder-sparing treatment options remain limited.

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XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Moreover, 40-50% of patients experience recurrent disease requiring the need for cystectomy, which is associated with significant risks and bladder-sparing treatment options remain limited.

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Antibody Trials Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes.

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Insulin Drugs FDA Approval Immune Response 97

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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Production FDA Approval Antibody Gene 52

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. The vaccine is given in two doses.

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Vaccine Vaccination Immune Response Protein 59

XTalks

MAY 16, 2025

While Apitox is not yet FDA-approved, a similar formulation known as Apitoxin has been used in South Korea since 2003 to manage osteoarthritis symptoms. Preclinical data suggest that bee venom components may modulate immune responses linked to the disease. which holds a majority ownership stake in the US entity.

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Licensing Licensing Immune Response Trials 52

XTalks

JULY 14, 2021

And the science backs this. The studies have shown that robust immune responses are achieved when a Pfizer vaccine dose is followed by a dose of AstraZeneca. And in turn, the question’s context was Pfizer’s recent announcement of seeking FDA approval for a third booster dose of its COVID-19 vaccine.

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Vaccine Vaccination Immune Response FDA Approval 98

XTalks

SEPTEMBER 23, 2021

one month after administration of the second dose, which indicates a strong immune response. In the US, the companies expect to submit the preliminary data in a near-term submission for Emergency Use Authorization (EUA) as they continue to collect the safety and efficacy data needed to file for full FDA approval in this age group.

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic.

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XTalks

MARCH 8, 2024

This evidence included comparisons of the products using an extensive array of physicochemical tests and biological assays to confirm the biosimilars’ similarity in efficacy, safety and immune response to the original drugs, the FDA explained.

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Drugs FDA Approval Production Immune Response 59

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. In early 2021, the FDA approved Pfizer’s Panzyga for the treatment of CIDP.

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XTalks

JUNE 10, 2024

Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

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Immune Response Dermatology Clinical Trials Clinical Trials 52

XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. Stelara Clinical Trial Results. Stelara is a human IgG1?

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Clinical Trials Clinical Trials Antibody Trials 52

XTalks

MARCH 13, 2023

For this reason, rare disease patient communities are hopeful for a new gene therapy that may result in long-term benefits to their quality of life and survival. Another thing Dr. Xu recommended is to monitor the immune response to gene therapy products.

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Gene Therapy Gene Clinical Trials Clinical 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. These antibodies bind strongly to their target and provide a robust immune response. Ongoing and Future Studies.

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Trials Antibody Genetics Gene 52

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

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. NAGS Deficiency Surrogate Endpoint: As a carbamoyl phosphate synthase activator, Carbalu took advantage of plasma ammonia as a surrogate endpoint for trials supporting its eventual FDA approval. Paget’s Disease.

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XTalks

NOVEMBER 12, 2024

FDA Approvals and Clinical Trials In February 2024, the US Food and Drug Administration (FDA) approved Ipsen’s Onivyde (liposomal irinotecan) as a first-line treatment for metastatic pancreatic cancer. In a small trial, half of the participants exhibited strong anti-tumor immune responses.

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Research FDA Approval Trials Clinical Trials 105

XTalks

JUNE 21, 2024

Capvaxive’s approval was partially based on data from four Phase III trials including the STRIDE-3 study, which found that the vaccine was non-inferior to comparator vaccine Prevnar 20. According to a November 2023 readout, Capvaxive also elicited superior immune responses for ten of the 11 serotypes not covered by Prevnar 20.

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FDA Approval Vaccine Vaccination Life Science 108

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

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FDA Approval Antibody Immune Response Drugs 97

XTalks

OCTOBER 25, 2022

Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death. Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo is administered as a single dose with Imfinzi, followed by Imfinzi infusions every four weeks.

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FDA Approval Trials Drugs Immune Response 98

XTalks

NOVEMBER 15, 2023

Related: FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration The FDA approval of Ixchiq was based on data from two clinical studies conducted in North America. In an analysis, the immune responses of 266 participants who received the vaccine were compared to those of 96 participants who received placebo.

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XTalks

JUNE 5, 2023

Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD. Safety and Efficacy of Abrysvo The FDA’s approval of Abrysvo is supported by compelling clinical evidence. percent and severe RSV-associated LRTD by 94.1 billion by 2028.

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XTalks

JULY 26, 2023

Related: Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Up to 37 percent of newly diagnosed AML patients have a mutation in the FLT3 gene and of these, 80 percent are FLT3 -ITD mutations. months for patients receiving Vanflyta compared to 12.4

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FDA Approval Immune Response Drugs Trials 98

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

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. At six months, 29.5

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Vaccine Vaccination Immune Response Trials 105

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

New and Promising Treatments for ALS Amylyx Pharmaceuticals, a biopharmaceutical company based in Cambridge, Massachusetts, obtained FDA approval in 2022 for its oral medication Relyvrio (sodium phenylbutyrate and taurursodiol) for the treatment of ALS.

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FDA Approval Gene Genetics Protein 89

XTalks

NOVEMBER 5, 2024

The FDA-approved FluMist , featured as one of TIME’s Best Inventions of 2024, exemplifies the appeal of needle-free, self-administered nasal vaccines for influenza. Polyrizon’s focus on intranasal protection aligns with a rapidly expanding market in drug delivery innovation.

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Drug Delivery Drugs Immune Response Allergies 111

Delveinsight

AUGUST 4, 2021

Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions. In June 2021, Aducanumab by Biogen received FDA approval to treat patients with Alzheimer’s disease. and Neurimmune are actively working in the Alzheimer’s Therapeutics Market.

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XTalks

AUGUST 17, 2020

Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. Cell-based immune therapies, including CAR-T cell therapy, have had some marked success, particularly in hematological cancers such as acute lymphocytic leukemia (ALL). Nature by Design.

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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). The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. The UK Government is behind this effort.

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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

OCTOBER 16, 2020

The FDA approval is based on results from the large, multi-center clinical trial called PALM (PAmoja TuLinde Maisha) in which Inmazeb showed superiority over other antiviral investigational agents, namely ZMapp and remdesivir, with respect to mortality.

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