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. It’s a very exciting time in gene therapy.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

XTalks

MAY 17, 2024

This day isn’t just a reminder of the medical challenge to find a safe and effective HIV vaccine, but also a tribute to the undertaking that has both challenged and intrigued researchers for over three decades. The Current Landscape of HIV Vaccine Research Today, the landscape of HIV research is filled with innovation.

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Vaccination Vaccine Research Immune Response 52

XTalks

DECEMBER 29, 2023

Reese, executive vice president of Research and Development at Amgen, in the company’s press release. 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).

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Clinical Trials Clinical Trials FDA Approval Trials 119

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.

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XTalks

JANUARY 20, 2021

Researchers at KU Leuven in Belgium have found a potential mechanism underlying irritable bowel syndrome (IBS) that involves activation of immune cells primed by past gastrointestinal infections. The research findings were published in the journal Nature. Related: Monitoring Patients with IBS or Kidney Failure?

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Immune Response Research Allergies Protein 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours.

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Regulation Vaccination Vaccine Trials 52

Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany.

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Drugs Life Science Gene Editing Gene 59

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

XTalks

AUGUST 13, 2020

The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. It is also dedicated to fostering innovations in care, clinical research, health education and the support of community health. Kaiser began Phase III trials of the vaccine at the end of July.

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Vaccination Vaccine Trials Clinical Trials 89

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. What are the major challenges you’re facing right now in vaccine development?

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Vaccination Vaccine Development Clinical Trials 96

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.,

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Vaccination Vaccine Trials Clinical Trials 59

XTalks

NOVEMBER 30, 2023

Over the last 35 years, substantial strides have been made in tackling HIV/AIDS, propelled by advancements in medical research, enhanced accessibility to treatment and prevention and a more comprehensive understanding of the virus. Notably, it significantly reduced viral load and clinical illness compared to a placebo.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

pharmaphorum

AUGUST 27, 2020

Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry. A world-class science and start-up ecosystem. COVID-19 sparks change.

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Vaccination Vaccine Life Science Clinical Trials 120

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

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.

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Clinical Trials Clinical Trials Antibody Life Science 52

XTalks

MAY 30, 2023

Established by the Multiple Sclerosis International Federation (MSIF) in 2009, World MS Day has quickly grown to be an influential movement that brings together various stakeholders that include patients and caregivers, researchers and healthcare professionals across more than 90 countries.

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Genetics Research Immune Response Drugs 98

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. Novavax Vaccine Research.

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Vaccination Vaccine Immune Response Protein 59

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.

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Clinical Trials Clinical Trials Trials Immune Response 59

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.,

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Immune Response Clinical Trials Clinical Trials Development 40

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. .

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Gene Therapy Gene Immune Response In-Vivo 52

Pharmaceutical Technology

JULY 22, 2022

Most experts believed that it would take a few years for the virus to become seasonal in nature after the global population gains greater immunity and as people return to their pre-pandemic lives, the article detailed. In addition, immunity against the infection is found to wane for both previously infected individuals and the vaccinated.

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Vaccination Vaccine Life Science Immune Response 130

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.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

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. The vaccine is currently being tested in children in Phase III trials and the company is hoping to get FDA approval by the end of the year.

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FDA Approval Vaccination Vaccine Immune Response 89

XTalks

SEPTEMBER 16, 2021

The federal health regulator maintains that boosters of Pfizer’s vaccine may not be needed, but in documents prepared for outside advisors, FDA scientists acknowledged yesterday that a third dose can heighten immune responses. Globally, about 88 percent of COVID-19 cases are from the Delta family.

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Vaccination Vaccine Immune Response Clinical Trials 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.

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Antibody Clinical Trials Clinical Trials Trials 52

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

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Vaccination Vaccine FDA Approval Protein 98

XTalks

FEBRUARY 29, 2024

Dual-function fusion proteins represent a cutting-edge approach in biopharmaceutical research, offering a promising avenue for the development of novel therapeutics in the treatment of complex diseases such as cancer and autoimmune disorders. My initial exposure to medicine came through bench research.

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Protein Development Clinical Trials Clinical Trials 94

XTalks

AUGUST 5, 2022

Register for this free webinar to learn why patient-centricity is important in rare disease research. The featured speakers will discuss how to facilitate trial participation in rare disease. Stelara Clinical Trial Results. Psoriatic Arthritis Clinical Trial Pipeline. Stelara is a human IgG1?

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Clinical Trials Clinical Trials Antibody Trials 52

XTalks

MAY 1, 2023

While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. Qalsody offers families who have lost generation after generation in the prime of their life to this devastating disease a therapy targeting the underlying cause of SOD1 -ALS.

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FDA Approval Gene Genetics Protein 89

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

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DNA Vaccination Vaccine Immune Response 40

XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. Adjuvants are used to help stimulate stronger vaccine immune responses. Based on the encouraging Phase I data, Medicago says it plans to proceed with its Phase II/III trials.

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Vaccination Vaccine Trials Immune Response 52

XTalks

OCTOBER 16, 2020

However, that outbreak was controlled before Regeneron’s drug could be tested in a clinical trial. A second Ebola outbreak occurred in August 2018 in the Democratic Republic of Congo (DRC), during which evaluation of Inmazeb was initiated in a large-scale clinical trial.

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Antibody Drugs Clinical Trials Clinical Trials 98

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Glenn, president of research and development at Novavax, in a news release. “It 1.351 variant.

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Protein Vaccination Vaccine Trials 97

pharmaphorum

SEPTEMBER 22, 2022

Le Vert says Osivax’s technology differs, however, as it attacks the virus’ T-cells, making the vaccine more effective in the long term, and that clinical trials have shown promise. The beauty of that T-cell response is that you can actually access the internal parts of the virus,” Le Vert states.

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Vaccination Vaccine Antibody Clinical Trials 96

Roots Analysis

DECEMBER 11, 2022

As per the International Agency for Research on Cancer (IARC), by 2040, there are likely to be 27.5 As a result, t-cell immunotherapies market is expected to pick up pace in the coming years adn is anticipated to be the next goldmine in the life sciences industry. million deaths in 2021, in the US alone.

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Marketing Production Genetics Immune Response 40

pharmaphorum

OCTOBER 12, 2022

Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”. Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.

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