XTalks

JANUARY 7, 2025

Symvess is a one-time, single-use, acellular tissue-engineered vessel (ATEV) composed of human extracellular matrix proteins. Secondary endpoints, such as infection rates, amputation and limb salvage, also favored Symvess, with the trial covering traumatic injuries from car accidents, gunshot wounds and industrial accidents.

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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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Gene Therapy Manufacturing Gene Clinical Trials 264

XTalks

APRIL 2, 2025

Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a successful Phase II trial in IgA nephropathy. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 59

Life Science Clinical Development Development Trials 59

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The Phase III VISIONARY trial enrolled 530 adults aged 18 to 65, with varying degrees of kidney function, and most were at risk of progressing to end-stage kidney disease.

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Trials Clinical Trials Clinical Trials Antibody 101

Pharmaceutical Technology

JANUARY 22, 2023

While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date. In clinical trials, the drug showed a 3.8-point point improvement (unadjusted means) and a 3.2-point

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Drugs Gene Hormones Clinical Trials 317

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

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations. Study Design Considerations.

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Clinical Trials Clinical Trials Trials Regulation 97

XTalks

APRIL 15, 2025

Hemophilia occurs when a clotting protein is missing or deficient, causing prolonged bleeding that can lead to joint damage and chronic pain. Despite these burdens, fewer than 5% of hemophilia clinical trials include female participants. In a cohort of 45 post-menarcheal girls in China, 46.7%

Gene Therapy 66

Gene Therapy Gene Clinical Trials Clinical Trials 66

XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. By inhibiting this protein, povorcitinib reduces the inflammatory signals that contribute to abscess and nodule formation. for placebo.

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Trials Clinical Trials Clinical Trials Hormones 59

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

NOVEMBER 21, 2024

It is characterized by the build-up of abnormal protein deposits in the heart tissue, leading to stiffening of the heart walls and impairing its ability to pump blood effectively. One such study, the PREVAMIC trial conducted in Spain , found that cardiac amyloidosis was present in 20.1

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Production Protein Life Science Trials 105

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

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Trials Gene Hormones Clinical Trials 98

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

XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. However, the company noted that cell-mediated immunity was not significantly impacted by omicron, as 85 percent of epitopes in the spike protein have been observed to be recognized by CD8+ T cells.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

XTalks

APRIL 9, 2025

Primary IgAN is a rare autoimmune disease in which deposits of IgA provoke glomerular inflammation and excessive protein leakage into the urine. Persistent proteinuria is a wellestablished risk factor for kidney function decline, with up to half of patients progressing to kidney failure within 10 to 20 years of diagnosis.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

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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Life Science Vaccination Vaccine FDA Approval 40

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 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)

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Vaccination Vaccine Protein Immune Response 98

pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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Vaccination Vaccine Development Immune Response 138

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

FEBRUARY 19, 2025

It occurs when a genetic error causes the overproduction of a protein called CSF1, which attracts inflammatory cells to the joint, often causing pain, swelling and reduced mobility. Looking ahead, Deciphera is exploring additional clinical trials and potential collaborations in the TGCT space.

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FDA Approval Drugs Trials Clinical Trials 59

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. What is Flow Cytometry?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

XTalks

OCTOBER 12, 2021

14-3-3 zeta) protein, which the UToledo researchers had been studying for its role in immune-related pathologies, such as aortic aneurysms and in signaling pathways involving the pro-inflammatory cytokine interleukin-17. However, they found the opposite to be true, where the protein was actually protective against development of the disease.

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Vaccination Vaccine Research Immune Response 105

Pharmaceutical Technology

APRIL 18, 2023

The FDA approved the drug based on positive Phase III data from the Lavender trial. In the trial, the non-placebo group had a change in the RSBQ from baseline to week 12 of -5.1, The condition is caused by a mutation in the methyl CpG binding protein (MECP2) gene, which controls the function of many other genes.

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Drugs FDA Approval Clinical Trials Clinical Trials 255

Pharma in Brief

NOVEMBER 18, 2020

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. The Trial Judge’s conclusion was consistent with the views of the experts he preferred and the principles in the governing jurisprudence. Trial decision. Appeal decision. Skilled person.

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Regulation Trials Protein Compliance 52

Delveinsight

JULY 29, 2021

Biogen-Ionis’ experimental drug meets primary goal in Alzheimer’s trial. Biogen and Ionis Pharmaceuticals have demonstrated that their experimental drug, BIIB080 (IONIS-MAPT), fulfilled the primary goal of safety and tolerability in the Phase Ib multiple ascending doses (MAD) clinical trials in mild Alzheimer’s disease patients.

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Drugs Protein Life Science Development 98

XTalks

NOVEMBER 10, 2020

Update (November 10, 2020): Pfizer and BioNTech announced in a press release yesterday that their candidate COVID-19 vaccine was found to be more than 90 percent effective in preventing infection by the novel coronavirus in Phase III trials. The ongoing Phase III trial continues to evaluate the mRNA vaccine in close to 44,000 individuals.

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Vaccination Vaccine Trials Clinical Trials 75

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Vaccination Vaccine Protein Trials 98

XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

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FDA Approval Sales Antibody Protein 66

XTalks

OCTOBER 22, 2024

transmembrane tight junction protein, which is commonly found in some gastric and GEJ cancers. gene, and an estimated 60 percent of all gastric cancers harbor the protein. In the SPOTLIGHT trial, Vyloy extended median PFS to 10.6 In the SPOTLIGHT trial, Vyloy extended median PFS to 10.6 months, compared to 8.7

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

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

NOVEMBER 23, 2021

Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials. The CDMO’s new manufacturing facility will have the capability to develop and manufacture nucleic acids, recombinant proteins and therapeutics expressed via microbial fermentation.

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Manufacturing Vaccination Vaccine Drugs 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. “On

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Big Data Drugs Clinical Trials Clinical Trials 122

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

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). It targets delta-like ligand 3 (DLL3), a protein usually found inside normal cells but abnormally present on the surface of SCLC cells.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

DECEMBER 5, 2023

As its active ingredient, repotrectinib inhibits the proto-oncogene tyrosine-protein kinase ROS1 and the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB and TRKC. The drug’s efficacy and safety were evaluated in the TRIDENT-1 study, an open-label, single-arm Phase I/II trial, focusing on both TKI-naïve and TKI-pretreated patients.

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Protein FDA Approval Medicine Trials 115

XTalks

MARCH 3, 2022

A successful connected products strategy is part of the digital transformation journey for many life science companies. The treatment involves taking a patient’s T cells and introducing a chimeric T cell receptor engineered to target specific proteins on tumor cells.

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FDA Approval Life Science Production Trials 98