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.

Life Science 52

Life Science Vaccination Vaccine Drugs 52

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. SL-172154 entered clinical trials in mid-2020, following promising preclinical results.

Protein 72

Protein Development Clinical Trials Clinical Trials 72

XTalks

SEPTEMBER 19, 2024

Mobasher 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. The mechanism of action of our BTK CDAC allows for complete degradation of the BTK protein and has distinct advantages over current BTK inhibitors.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 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.

Life Science 92

Life Science Vaccination Vaccine Trials 92

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.

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

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.

Clinical Trials 97

Clinical Trials Clinical Trials Trials FDA Approval 97

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.

Development 130

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?

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

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.

Protein 85

Protein Vaccination Vaccine Trials 85

XTalks

NOVEMBER 7, 2024

Duchenne’s hallmark is the lack of dystrophin, a protein essential for muscle health. Ambulatory patients receive traditional approval, while non-ambulatory cases are covered under accelerated approval, pending further trials. Clinical trials show promising response durations of 9.7 million Americans.

Gene Therapy 96

Gene Therapy Gene Editing Gene FDA Approval 96

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.

Gene Therapy 264

Gene Therapy Manufacturing Gene Clinical Trials 264

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The primary endpoint of the trial was a reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo after nine months of treatment, which indicates improved kidney function.

Trials 83

Trials Clinical Trials Clinical Trials Antibody 83

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.

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

Clinical Trials 114

Clinical Trials Clinical Trials FDA Approval Trials 114

XTalks

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). As of March 2024, the FDA has approved six small interfering RNA (siRNA) therapies.

Trials 52

Trials RNA Protein Gene Editing 52

XTalks

NOVEMBER 22, 2024

NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinical trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. Together, they form a once-daily oral therapy designed for patients who cannot achieve their targets with current treatments.

Trials 65

Trials Clinical Research Clinical Trials Clinical Trials 65

XTalks

JULY 29, 2024

This blog will discuss new US Food and Drug Administration(FDA)-approved treatments, promising clinical trials and the latest advancements in lung cancer research, providing hope for better patient outcomes. This MET inhibitor targets the abnormal MET protein, helping to shrink tumors. percent.

Research 59

Research Clinical Trials Clinical Trials FDA Approval 59

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.

Gene Editing 100

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.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

XTalks

JUNE 18, 2024

.” — Aki Ko Additionally, Elixirgen Therapeutics has unveiled promising preclinical results for its Bobcat mRNA technology at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.

Protein 52

Protein RNA Genetics Clinical Trials 52

XTalks

JUNE 11, 2024

These statistics underscore the urgent need for innovative treatments and inclusive clinical trials that can address the diverse needs of the lupus population. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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.

Drugs 93

Drugs Clinical Trials Clinical Trials Trials 93

XTalks

OCTOBER 16, 2024

Hympavzi reduces the activity of TFPI, a naturally occurring anticoagulation protein. Hympavzi is the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the US for hemophilia A or B, and it’s also the first hemophilia therapy to be administered via a pre-filled auto-injector pen.

FDA Approval 98

FDA Approval Trials Clinical Trials Clinical Trials 98

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.

Gene Therapy 98

Gene Therapy Gene Clinical Trials Clinical 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.

FDA Approval 102

FDA Approval Protein RNA Clinical Trials 102

XTalks

NOVEMBER 5, 2024

a clinical-stage biotech company focused on pioneering therapies based on G protein-coupled receptors (GPCRs), recently completed its initial public offering (IPO), marking a significant milestone for the South San Francisco-based firm. Regulatory submissions for trial initiation are anticipated soon. Septerna, Inc.,

Drugs 59

Drugs Hormones Protein Antibody 59

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.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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?

Clinical Trials 81

Clinical Trials Clinical Trials Trials Antibody 81

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.

Trials 105

Trials Clinical Trials Clinical Trials Genetics 105

XTalks

AUGUST 27, 2024

Rybrevant is a bispecific antibody that works by targeting the EGFR and MET proteins involved in cancer cell growth. The MARIPOSA study is part of an extensive clinical trial program evaluating the efficacy of Rybrevant in various NSCLC settings.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

OCTOBER 9, 2024

The study, which is the first global study for ivonescimab, targets a patient population where previous Phase III global clinical trials using PD-1 monoclonal antibodies have not been successful. The company says more than 1,800 people have been treated with the antibody across all clinical trials to date.

Trials 52

Trials Antibody Clinical Trials Clinical Trials 52

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).

FDA Approval 88

FDA Approval Life Science Clinical Trials Clinical Trials 88

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.

Life Science 52

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.

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

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.

Vaccination 98

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.

Big Data 122

Big Data Drugs Clinical Trials Clinical Trials 122

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. mRNA therapies work by instructing cells to produce specific proteins that can enhance the body’s natural defenses or correct deficiencies.

Development 52

Development Drugs Immune Response Protein 52