XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

Drug Delivery 84

Drug Delivery Drugs Immune Response Allergies 84

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. During pregnancy, CMV infection is responsible for causing severe birth defects and brain damage in newborns.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

XTalks

DECEMBER 29, 2023

Tarlatamab is an investigational drug currently undergoing clinical trials to assess its efficacy in patients with two distinct types of neuroendocrine cancer: SCLC and neuroendocrine prostate cancer (NEPC). As a bispecific T-cell engager immunotherapy, tarlatamab directs the patient’s T cells to attack cancer cells exhibiting DLL3.

Clinical Trials 106

Clinical Trials Clinical Trials FDA Approval Trials 106

XTalks

NOVEMBER 12, 2024

World Pneumonia Day 2024 provides an opportunity to examine the latest advances in pneumonia treatment and prevention — and the role that healthcare and life sciences industries play in reducing its global impact. These therapies work by controlling excessive inflammatory responses in the lungs.

Bacteria 91

Bacteria Life Science Vaccination Vaccine 91

XTalks

AUGUST 8, 2022

Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash.

Immune Response 89

Immune Response Antibody Life Science Engineer 89

XTalks

OCTOBER 11, 2024

The vaccine uses recombinant RSV glycoprotein F, stabilized in its prefusion conformation (RSVPreF3), along with GSK’s AS01E adjuvant to boost the immune response — the same adjuvant used in Shingrix, its shingles vaccine, but at a lower dose.

Vaccination 83

Vaccination Vaccine Immune Response Trials 83

XTalks

NOVEMBER 30, 2023

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. Additionally, Gag-specific CD8+ T cells demonstrated an increase of 1.7

FDA Approval 108

FDA Approval Gene Therapy Clinical Trials Gene 108

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. Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care.

Research 92

Research Dermatology Clinical Trials Clinical Trials 92

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, The inhalant version.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

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.

Immune Response 98

Immune Response Dermatology Clinical Trials Clinical Trials 98

The Pharma Data

NOVEMBER 1, 2020

Clinical Data Expected by End of Year. Tiziana Life Sciences plc. (“Tiziana” or the “Company”). This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Life Science 52

XTalks

OCTOBER 1, 2024

Langenickel Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. These aggregates can trigger unwanted immune responses and reduce transfection efficiency.

Development 52

Development Drugs Immune Response Protein 52

Pharmaceutical Technology

NOVEMBER 22, 2022

The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. billion towards the “pandemic-busting plan”, which involves the investigation of rapid response vaccine technologies. The UK Government is behind this effort.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

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. Tamibarotene is a selective agonist of retinoic acid receptor alpha/beta, with potential binding to retinoid X receptors (RXR).

Trials 70

Trials HR Immune Response FDA Approval 70

XTalks

JANUARY 20, 2021

While diseases like celiac are associated with inappropriate activation of the immune system triggered by food antigens, this is not the case in IBS. In a normal, healthy intestine, foods do not trigger immune responses and so in a patient with IBS, something else must activate the response. Mouse and Human Studies.

Immune Response 52

Immune Response Research Allergies Protein 52

XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

Vaccination 63

Vaccination Vaccine Trials Clinical Trials 63

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

Vaccination 74

Vaccination Vaccine Development Clinical Trials 74

pharmaphorum

NOVEMBER 29, 2022

Number of on-going clinical trials: 14. T cells are known to mediate anti-tumor immune responses. For that reason, they have become the key target of immune checkpoint therapies, like PD-(L)1 agents. Locations: 3 (US HQ, Korea office, Korea R&D center). Number of employees: 90+ (as of Oct. Creation: Jan.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Engineer 105

XTalks

SEPTEMBER 27, 2024

Link Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Syncromune’s Future Directions Syncromune is expanding clinical trials and exploring SYNC-T’s application in other tumor types.

Immune Response 59

Immune Response Drugs Trials Clinical Trials 59

XTalks

APRIL 26, 2021

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. Malaria Vaccine Phase II Trial. At six months, 29.5

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results. Results from the PREVENT-19 pediatric expansion trial showed that the vaccine was also effective in adolescents aged 12 to 17 years. NVX-CoV2373 also includes an adjuvant called Matrix-M.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

XTalks

JANUARY 8, 2021

Both vaccines demonstrated an effectiveness of about 95 percent in Phase III clinical trials. Others have voiced concern that clinical trials have not evaluated half doses nor different dosing schedules. The agency says, “These are all reasonable questions to consider and evaluate in clinical trials.

Vaccination 138

Vaccination Vaccine Clinical Trials Clinical Trials 138

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.

FDA Approval 52

FDA Approval Vaccination Vaccine Pharmacy 52

pharmaphorum

JULY 20, 2021

The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351) 1.351) variant first identified in South Africa. The post EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine appeared first on.

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

XTalks

MARCH 19, 2024

These cells are crucial for the body’s immune response, producing antibodies that help fight infection. However, when these cells become cancerous, they proliferate uncontrollably, leading to a myriad of health issues, including bone damage, kidney failure and impaired immune function.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Immune Response 59

pharmaphorum

AUGUST 27, 2020

The Biotechnology and Biological Sciences Research Council (BBSRC), part of UK Research and Innovation (UKRI), works with universities, research organisations, businesses, charities, and government to develop a supportive ecosystem. The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials.

Vaccination 122

Vaccination Vaccine Life Science Clinical Trials 122

XTalks

NOVEMBER 22, 2022

In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo. Tzield’s FDA approval was based on safety and efficacy data from a randomized, double-blind, event-driven, placebo-controlled trial involving 76 patients with stage 2 type 1 diabetes.

Insulin 80

Insulin Drugs FDA Approval Immune Response 80

XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

Vaccination 79

Vaccination Vaccine Clinical Trials Clinical Trials 79

The Pharma Data

JANUARY 3, 2021

Weber is a renowned melanoma specialist and leading immunotherapy translational and clinical scientist. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. GAITHERSBURG, Md.,

Immune Response 40

Immune Response Clinical Trials Clinical Trials Development 40

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. There were no significant safety findings reported through day 29. Mixed Results.

Vaccination 90

Vaccination Vaccine Immune Response Antibody 90

Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

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.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

XTalks

JULY 28, 2021

While Merck’s previous shot, Pneumovax 23, defends against 23 serotypes and has been on the market for almost four decades, the immune responses it generates are not as durable as Prevnar 13. This is why Pfizer’s Prevnar 13 has dominated the pneumonia vaccine space for more than a decade.

FDA Approval 64

FDA Approval Vaccination Vaccine Immune Response 64

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

Vaccination 94

Vaccination Vaccine FDA Approval Protein 94