XTalks

MAY 10, 2023

Read more about the vaccine, including clinical trial results on its efficacy and safety. The treatment, an antisense oligonucleotide developed by Biogen, targets abnormal proteins arising from SOD1 mutations, which are associated with the development of ALS in some patients.

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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. Herceptin (Trastuzumab) and Mabthera (Rituximab).

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XTalks

JULY 20, 2022

It is also the first protein-based COVID-19 vaccine to be authorized in the country. Read the full articles here: Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Life Science Vaccination Vaccine Drugs 52

XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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XTalks

JULY 19, 2022

The two-dose protein-based, adjuvanted vaccine has been authorized for use in adults 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. In a press release outlining the authorization, the FDA noted that the clinical trial for Novavax’s vaccine was conducted before the appearance of the omicron and delta variants.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Exosome-Based Liquid Biopsy in Oncology.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

DECEMBER 24, 2020

The pandemic propelled the life science and healthcare sectors onto center stage, and they rose to the occasion against the most unprecedented health challenge in recent times. While COVID-19 has undoubtedly been the biggest story in the life science industry in 2020, it was a busy and positive year in many other areas.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

Pharmaceutical Technology

OCTOBER 20, 2022

The funding round saw participation from current investors of the company, Advent Life Sciences and Belinda Termeer. The company will utilise the Series A funds to progress its small molecule drug presently in development into first-in-human clinical trials for advanced metastatic breast cancer.

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Development Drugs Protein Life Science 130

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry? What is a Receptor Occupancy Assay?

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Clinical Trials Clinical Trials Trials Antibody 98

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 1.351 variant.

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Protein Vaccination Vaccine Trials 97

Pharmaceutical Technology

MARCH 10, 2023

In an email to Pharmaceutical Technology , an NHSBT spokesperson said the centre will “support early phase clinical trials and preclinical work, providing a route to eventual commercial scale production”. In the past, researchers have often had to seek help from outside the UK, thus delaying clinical trials and patient access.

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XTalks

FEBRUARY 19, 2024

The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. The comparison is particularly important as gB/MF59 demonstrated promise in Phase II clinical trials but did not advance to Phase III.

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

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Clinical Trials Clinical Trials FDA Approval Trials 119

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The drug candidate targets DNA-dependent protein kinase (DNA-PK). Merck KG, is a science and technology company. The company serves healthcare, performance materials, and life sciences markets.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The drug candidate targets DNA-dependent protein kinase (DNA-PK). Merck KG, is a science and technology company. The company serves healthcare, performance materials, and life sciences markets.

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Gene Editing DNA Cosmetics Life Science 100

XTalks

MAY 24, 2022

The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Lenacapavir is designed to act as an inhibitor of the HIV capsid protein, and it inhibits the virus at distinct stages (early and late) of its life cycle.

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Drugs Clinical Trials Clinical Trials Trials 98

XTalks

JANUARY 3, 2024

In individuals affected by ATTR, which includes both hereditary and wild-type (non-hereditary) variants, the TTR protein forms fibrils that accumulate in various tissues. Safety and Efficacy of Wainua The FDA’s approval of Wainua is underpinned by compelling clinical data. This conjugation facilitates ASO delivery to hepatocytes.

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FDA Approval Protein RNA Clinical Trials 105

XTalks

DECEMBER 12, 2023

The world of neuroscience trials is rapidly evolving, presenting new challenges and opportunities for researchers and clinicians. The worldwide market for neurology clinical trials stood at a valuation of $5.24 There is currently a heightened emphasis on imaging and liquid biomarkers in neuroscience clinical trials.

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Trials Clinical Trials Clinical Trials Genetics 111

XTalks

JULY 17, 2023

protein on the surface of gastric epithelial cells, which display abnormal expression levels of this protein compared to normal cells. Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. How Does Zolbetuximab Work?

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Clinical Trials Clinical Trials Trials Antibody 95

Drug Discovery World

DECEMBER 20, 2022

These are proteins critical for mounting potent anti-tumour responses and are used in immunotherapy to activate or enhance the body’s response. . The research was led by Dr Ignacio Moraga, from Dundee’s School of Life Sciences, alongside colleagues from Lille University and the University of Cambridge .

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Protein Life Science Engineer Clinical Trials 52

XTalks

AUGUST 30, 2022

The hemophilia A gene therapy Roctavian delivers a functional gene to enable the body to make an essential blood clotting protein on its own. A lack of sufficient functioning factor VIII and factor IX blood clotting proteins would result in the development of hemophilia A and hemophilia B, respectively.

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Gene Therapy Gene Clinical Trials Clinical Trials 98

XTalks

SEPTEMBER 21, 2023

“HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection, in the company’s press release. mRNA, 2) BG505 MD39.3 gp151 mRNA and 3) BG505 MD39.3 gp151 CD4KO mRNA.

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Vaccination Vaccine Trials Clinical Trials 59

XTalks

MARCH 28, 2024

Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council – Xtalks Life Science Podcast Ep. Early clinical trials have shown promising results and this therapy could become a valuable addition towards CRC treatment in the future.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

XTalks

FEBRUARY 20, 2024

Consequently, this damage causes blood and protein leakage into the urine. At month 12, the percentage of patients achieving clinical remission was 7.9 These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

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Clinical Trials Clinical Trials FDA Approval Trials 59

Drug Discovery World

FEBRUARY 5, 2024

The launches include an integrated solution suite for liquid biopsy workflows, and the Resolvex i300 and antibody purification columns AffinEx Protein A Capture, adding biomarker discovery, drug development and personalised medicine research to proteomics workflows.

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Gene Therapy Life Science Production Dermatology 64

XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

MARCH 13, 2024

Related: Transforming Eye Care: Innovating New Glaucoma and Dry Eye Disease Treatments — Featuring Pierre Simon, VP Marketing, Sight Sciences – Xtalks Life Science Podcast Ep. In certain populations, up to 50 percent of individuals are unaware that they have glaucoma.

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Gene Therapy Gene Life Science DNA 111

Drug Discovery World

OCTOBER 20, 2023

Its proprietary technology, Proximity Extension Assay (PEA), provides high throughput protein analysis. Through the purchase, Thermo Fisher will also gain a library of more than 5,300 validated protein biomarker targets.

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Drugs Antibody DNA Gene Therapy 52

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.

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Vaccination Vaccine FDA Approval Protein 98

pharmaphorum

JANUARY 11, 2023

Today’s pharmaceutical drug discovery process essentially relies on trial and error,” he expanded. “To To find potential drug candidates, disease-associated protein targets are tested against a small pool of less than ten million distinct chemotypes synthesised at great effort and expense over the past 100 years.

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Big Data Drugs Clinical Trials Clinical Trials 121

XTalks

MAY 9, 2024

XTALKS CLINICAL EDGE: Issue 2 — Genmab’s Interview 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. Celebrating 25 years of innovation is a significant milestone.

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Antibody Clinical Trials Clinical Trials Medicine 52

XTalks

APRIL 11, 2024

RELATED ON-DEMAND XTALKS WEBINAR: Leveraging Digital Biomarkers to Generate Real-World Physiological and Behavioral Data in CNS Clinical Studies Register for this free webinar to learn about an AI-based, multi-domain digital biomarker platform designed to provide objective, diverse and home-based patient data collection in CNS clinical trials.

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Clinical Trials Clinical Trials Development Clinical Development 110

The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — Caris Life Sciences® , a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced today that Winship Cancer Institute of Emory University (Winship) has joined Caris’ Precision Oncology Alliance (The Alliance/POA). Winship is one of 32 U.S.

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Life Science Clinical Trials Clinical Trials RNA 52

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The post EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine appeared first on.

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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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Drug Discovery World

MAY 11, 2023

Fundraising and investment are a core pillar of not just BioTrinity events but of the drug discovery industry at large, so events such as Tuesday’s keynote, Investment Trends for the Life Sciences Industry, are critical for members of the industry.

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