FDA lifts hold on PTC Huntington’s disease trial
Bio Pharma Dive
JUNE 20, 2024
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
This Protein May Protect Against Alzheimer’s, Scientists Say
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2023
In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.
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This Protein Could Help Us Unravel The Mystery of Alzheimer’s
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 28, 2024
The new research centers on the protein contactin-4 (CNTN4) – thought to play a role in neuronal network […] There are a lot of connected, moving biological parts in our brains, which makes the study of brain diseases particularly challenging.
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A Common Sleeping Pill May Reduce Buildup of Alzheimer’s Proteins, Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 8, 2024
In a study published in 2023, scientists found that using sleeping pills to get some shut-eye could reduce the build-up of toxic clumps of proteins […]
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Blocking a Single Protein Could Prevent Nerve Damage Responsible For Alzheimer’s
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 10, 2024
Scientists have identified a key protein in the development of Alzheimer’s disease which could prove critical in slowing or even halting the condition’s progress.
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Flashing Lights And a Clicking Sound Cleared Toxic Proteins in Alzheimer’s Mice
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 7, 2024
Scientists have now demonstrated how stimulating high-frequency brain waves in mice can clear out the amyloid protein clumps associated with Alzheimer’s. Could Alzheimer’s disease one day be treated by flashes of light and clicks of sound?
Protein 242
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A biotech shelves its Huntington's drugs after trial failures
Bio Pharma Dive
MARCH 30, 2021
Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
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For The First Time, Scientists Capture The Protein-Lipid Dance on Video
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 28, 2024
Our bodies are alive with activity and packed with proteins jammed into fatty membranes or floating in and out of watery cells. Scientists have now, for the first time, captured the dance between the two: a liquid tango featuring proteins and fats as they would normally move in cells.
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Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials
XTalks
DECEMBER 10, 2024
Rilzabrutinib works by targeting BTK, a protein involved in immune cell communication. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production. Its selective mechanism aims to minimize off-target effects, making it a potential first-in-class treatment for ITP.
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Sanofi drug for rare skin disease, acquired in buyout, fails in late-stage trial
Bio Pharma Dive
SEPTEMBER 9, 2021
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
Protein 304
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The Vital Role of Biomarkers in Neurodegenerative Pathways Early Phase Unit, Worldwide Clinical Trials
Worldwide Clinical Trials
APRIL 15, 2025
Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Integration of fluid biomarkers, imaging, and genetic profiling enhances diagnostic precision and provides valuable tools for clinical trials in ALS.
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Roche's closely watched immunotherapy fails key study in tough-to-treat lung cancer
Bio Pharma Dive
MARCH 30, 2022
A drug regimen including Roche's top prospect tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.
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Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial
Pharmaceutical Technology
JUNE 15, 2023
Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. The regimen in the trial was a one-week monotherapy period (1.5
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Alyftrek: Vertex Expands Cystic Fibrosis Treatment with Triple-Action Combo
XTalks
JANUARY 6, 2025
CF is a progressive genetic disease caused by defective CFTR proteins, which are crucial for regulating salt and water movement in cells. These mutations can vary in severity and impact on CFTR function, from complete protein dysfunction to defects in protein folding, trafficking or regulation.
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Aqilion and Merck partner to develop TAK1 protein inhibitors
Pharmaceutical Technology
FEBRUARY 16, 2023
Aqilion and Merck have entered an exclusive licence and strategic research partnership for the discovery, development and commercialisation of the transforming growth factor-β-activated kinase 1 (TAK1) protein-small molecule inhibitors. Merck will be responsible for leading the preclinical pharmacology and biology trials.
Protein 147
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Kymera’s protein degrader starts Phase II trial in atopic dermatitis
Pharmaceutical Technology
DECEMBER 8, 2023
Following the dosing of the first patient in Phase II atopic dermatitis trial, Kymera received a $15m milestone payment from Sanofi.
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Novavax starts first large-scale coronavirus vaccine trial in UK, as cases surge
Bio Pharma Dive
SEPTEMBER 25, 2020
The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.
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Surprise Alzheimer’s Finding: Brain’s Support Cells May Be Fueling Disease
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2024
Neurons aren’t the only brain cells producing the proteins associated with Alzheimer’s disease, a new study of mouse models reveals. Amyloid beta proteins occur naturally in our brains, but have long, and now controversially, been associated with Alzheimer’s disease. “Until now, neurons were […]
Protein 245
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Vepdegestrant Hits Primary Endpoint in Phase III Breast Cancer Trial
XTalks
MARCH 11, 2025
Vepdegestrant, an investigational oral therapy, utilizes PROteolysis TArgeting Chimera (PROTAC) technology a mechanism that harnesses the bodys natural protein disposal system to selectively target and degrade the estrogen receptor.
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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults
Pharmaceutical Technology
JUNE 24, 2022
The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-based Matrix-M adjuvant.
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Frontotemporal dementia: the state of treatment development
Pharmaceutical Technology
FEBRUARY 20, 2023
Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials. This includes Denali Therapeutics whose treatment TAK-594/DNL593 is in a Phase I/II trial. This protein promotes lysosomal function. The trial features four cohorts.
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China grants EUA to Covid-19 vaccine against XBB descendent lineages
Pharmaceutical Technology
JUNE 9, 2023
5+delta) protein vaccine (Sf9 cell). The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HR proteins of the XBB and BA.5 It is self-assembled into stable trimeric protein particles with the addition of squalene-based oil-in-water emulsion adjuvant following purification and mixing.
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Karyopharm receives US and Europe regulatory designations for eltanexor
Pharmaceutical Technology
JULY 21, 2022
It works by attaching to and hindering the nuclear export protein, XPO1, causing the build-up of tumour suppressor proteins in the cell nucleus. The company is analysing eltanexor in an open-label Phase I/II clinical trial underway in relapsed/refractory MDS patients.
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Six Minutes of Intense Exercise Boosts a Crucial Molecule in Your Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2023
Six minutes of high-intensity exercise is enough to produce a key protein in the brain, one that’s important in brain formation, function, and memory, and which has been implicated in the progress of neurodegenerative disorders such as Alzheimer’s disease.
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Obicetrapib Lowers LDL-C as Monotherapy and with Ezetimibe in Phase III Trials
XTalks
DECEMBER 26, 2024
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
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AstraZeneca study points to new uses for targeted cancer drug Enhertu
Bio Pharma Dive
JUNE 5, 2023
Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.
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Mice That Eat Less Live Longer – And We May Finally Know Why
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 24, 2024
We’ve known for over a century that mice and rats live longer when they are fed less, but a new study reveals the secret might be an imbalance between energy consumed and burned, rather than a lack of energy or protein. Researchers from the US and UK studied groups of mice put on identical diets, […]
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How did pharma develop a vaccine so quickly?
World of DTC Marketing
DECEMBER 29, 2020
Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.
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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents
Pharmaceutical Technology
JULY 6, 2022
A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The CMA was based on findings from the paediatric expansion of Phase III PREVENT-19 clinical trial of 2,247 adolescents of the age 12 to 17 years at 73 sites in the US.
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Health Canada approves Novavax’s Covid-19 vaccine for adolescents
Pharmaceutical Technology
DECEMBER 7, 2022
Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.
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Your Body’s Internal Clock May Boost Cancer Treatments, Scientists Say
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 19, 2024
link] Checkpoint inhibitors are immunotherapy drugs that block crucial proteins from binding to cancerous tumors, meaning the immune system’s T cells can more easily […]
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US FDA grants Fast Track status for Avidity’s AOC 1020 to treat FSHD
Pharmaceutical Technology
JANUARY 19, 2023
This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients. Avidity Biosciences’ AOC 1020 is intended to reduce the DUX4 mRNA and DUX4 protein expression in muscles in these patients.
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Cheap Daily Supplement Seems to Boost Brain Function in Older Adults
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 5, 2024
The first twin study of its kind suggests that taking daily protein and prebiotic supplements can improve scores on memory tests in people over the age of 60. What’s good for your aging gut may also be good for your aging brain. The findings are food for thought, especially as the same visual memory and […]
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How Old Are Your Eyes? New ‘Clock’ Could Reveal Disease Risk
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 1, 2023
Almost 6,000 proteins detected in the fluid could be traced […] Scientists have developed a new tool for determining the age of eye cells without sampling regenerative tissue, which could make treatments for eye disease more personalized and better targeted.
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A Type of Fiber Could Have Weight Loss Benefits Similar to Ozempic
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2025
(courtneyk/Getty Images) Research on the gut microbiome has triggered a ‘revolution‘ in nutritional science, and in the last few years, dietary fiber has become the “new protein” added to foods in abundance to feed our gut and boost our health.
Protein 231
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Scientists Discover a New, Unexpected Way That Cancer Cells Spread
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2023
Key to this newly discovered process is GRP78, and it’s what’s known as a chaperone protein. One of the challenges in treating cancer is stopping it from metastasizing, and a new study reveals one of the fundamental mechanisms through which this happens. Now we know about this mechanism, perhaps we can stop it.
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FDA advisers support conditional clearance of Biogen’s ALS drug
Bio Pharma Dive
MARCH 22, 2023
Though the drug, called tofersen, missed the main goal of a key clinical trial, it showed an effect on a protein tied to ALS. Experts see that as a good sign, but some worry Biogen has not yet gathered enough supportive evidence.
Drugs 184
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Moderna’s HIV vaccine prepped for trials in Africa
pharmaphorum
MAY 19, 2022
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.
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Arvinas gets positive breast cancer data, but finds differentiation a hard sell
Bio Pharma Dive
MARCH 11, 2025
Trial results show vepdegestrant, a protein-degrading drug Arvinas is developing with Pfizer, improved on fulvestrant in a subgroup of breast cancer patients, but not the overall study population.
Protein 157
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A Simple Blood Test Could Soon Predict Your Risk of Dementia
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 19, 2024
A detailed look at minute differences in the levels of specific proteins in blood has allowed researchers to identify potential early warning signs of dementia.
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India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine
Pharmaceutical Technology
SEPTEMBER 7, 2022
A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals. The vaccine was assessed in Phase I, II and III clinical trials with successful data.
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Novel CSF biomarkers signal new avenues for Parkinson’s therapeutics
Pharmaceutical Technology
OCTOBER 18, 2022
Last week, Nature magazine published a paper detailing an in-situ study of Parkinson’s disease (PD), showing protein structural changes in cerebrospinal fluid (CSF) between healthy individuals and Parkinson’s patients. The research team identified 117 highly variable peptides originating from 64 unique proteins.
Protein 264
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Alzheimer’s Might Not Actually Be a Brain Disease, Expert Says
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 21, 2022
In July 2022, Science magazine reported that a key 2006 research paper, published in the prestigious journal Nature, which identified a subtype of brain protein called beta-amyloid as the cause of Alzheimer’s, […].
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