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

NOVEMBER 15, 2024

These RXR receptors play a key role in regulating transcription pathways involved in inflammation and immune responses, among other cancer hallmarks, to modulate the tumor microenvironment. This is significant as the therapy can reduce or eliminate the need for frequent blood transfusions.

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Trials HR Immune Response FDA Approval 105

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

Pharmaceutical Technology

OCTOBER 25, 2022

In September, the company’s Imfinzi (durvalumab) plus ch emotherapy received FDA approval for the treatment of locally advanced or metastatic biliary tract cancer in adults. Regulatory applications for combination therapy for advanced liver cancer treatment are currently being reviewed in Japan, Europe and various other countries. .

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Protein Immune Response Antibody FDA Approval 173

XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).

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Research Dermatology Clinical Trials Clinical Trials 105

STAT News

DECEMBER 23, 2022

In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response. The most common side effect was an overactive immune response called cytokine release syndrome, reported by 39% of patients. Continue to STAT+ to read the full story…

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FDA Approval Immune Response Drugs Research 98

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

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.

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FDA Approval Vaccine Vaccination Clinical Trials 102

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

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 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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FDA Approval Vaccine Vaccination In-Vitro 59

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

OCTOBER 28, 2022

What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending.

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Vaccination Vaccine Marketing Bacteria 162

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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FDA Approval Vaccine Vaccination Pharmacy 52

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 Clinical Trials Clinical Trials 111

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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FDA Approval Vaccination Vaccine Containment 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing 161

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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Vaccination Vaccine FDA Approval Protein 98

XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The results showed that the vaccine had no serious safety concerns and elicits immune responses against four different strains of the influenza virus.

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Life Science FDA Approval Vaccination Vaccine 40

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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Immune Response Medicine Vaccine Vaccination 52

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

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

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

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). When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. With the world watching, the biopharmaceutical community got to work.

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Manufacturing Vaccination Vaccine RNA 130

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

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

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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Vaccination Vaccine FDA Approval Containment 52

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

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

The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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Licensing Licensing Vaccination Vaccine 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

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares. . Over-the-counter treatments fail due to the body’s natural protective system.

FDA Approval 52

FDA Approval Immune Response Drug Delivery Drugs 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.

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Vaccine Vaccination Protein Immune Response 111

pharmaphorum

APRIL 26, 2022

The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval. Compelling advantages.

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Containment Development Production Drugs 115

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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Vaccination Vaccine Immune Response Protein 52