Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients
Pharma Times
FEBRUARY 12, 2024
The platform delivers digitalised patient data to improve clinical trials and development
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Pharma Times
FEBRUARY 12, 2024
The platform delivers digitalised patient data to improve clinical trials and development
Rethinking Clinical Trials
OCTOBER 2, 2023
The Patient-Centered Outcomes Core has developed a new tool kit to provide resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The post October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs appeared first on Rethinking Clinical Trials.
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Drug Discovery World
AUGUST 4, 2022
It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. However, starting early can greatly improve the efficiency and speed of the development process. Never too early.
Pharmaceutical Technology
DECEMBER 12, 2022
Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Additionally, Kite will make other potential payments to Arcellx.
Pharmaceutical Technology
OCTOBER 6, 2022
from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.
XTalks
APRIL 25, 2024
Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace. Survival rates were also impressive, exceeding 90 percent at one year.
Camargo
OCTOBER 14, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence.
pharmaphorum
JANUARY 14, 2022
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.
Camargo
NOVEMBER 29, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.
Camargo
DECEMBER 10, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This means that full approval can only come from a clinical trial that assesses adult height. Voxzogo also received a priority review voucher.
XTalks
MAY 4, 2023
When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments.
Pharmaceutical Technology
MAY 11, 2023
The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. A global randomised follow-up trial is planned. In 2016, BioNTech and Genentech, a part of Roche signed an agreement to develop personalised mRNA therapies in oncology.
Camargo
JANUARY 14, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. If you are developing a combination product, Camargo can help you design the fastest, most efficient path to approval. Co-Authors: Ken Phelps.
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.
Drug Discovery World
DECEMBER 6, 2022
As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. Indeed, few randomised trials of NPIs have been undertaken. Quasi-experimental and other randomised trial designs . Pre-specification of effect size .
Camargo
DECEMBER 13, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.
Pfizer
AUGUST 3, 2022
Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint.
pharmaphorum
DECEMBER 4, 2022
Clinical trials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event. The post Elon Musk’s Neuralink brain interface chip set for human trials appeared first on.
Pharmaceutical Technology
APRIL 14, 2023
Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.
Camargo
JUNE 4, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. In the News: May 2021 Regulatory and Development Updates. In the News: April 2021 Regulatory and Development Updates.
Drug Discovery World
MARCH 28, 2023
SolasCure’s first investigational product, Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots which aims to accelerate wound debridement, is due to enter further Phase II efficacy-supporting trials. funding to develop Aurase Wound Gel appeared first on Drug Discovery World (DDW).
Drug Discovery World
OCTOBER 31, 2023
UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. The drug was developed over eight years by Brian Bigger, Professor of Cell and Gene Therapy at The University of Manchester.
pharmaphorum
NOVEMBER 28, 2021
An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. billion takeover of Sativex’ developer GW Pharma earlier this year. Jazz acquired rights to Sativex when it completed its $7.2
XTalks
NOVEMBER 29, 2022
Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.
Drug Discovery World
MAY 17, 2024
Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.
Pharmaceutical Technology
APRIL 28, 2023
It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.
Pharmaceutical Technology
OCTOBER 31, 2022
After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic.
Camargo
APRIL 20, 2021
This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.
XTalks
APRIL 24, 2023
Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.
pharmaphorum
SEPTEMBER 14, 2020
AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.
Cloudbyz
SEPTEMBER 16, 2023
Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders.
Drug Discovery World
AUGUST 9, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.
Drug Discovery World
OCTOBER 19, 2022
Yapan Bio has expanded its capabilities with a new process development facility at Genome Valley, Hyderabad, India, which has enhanced its ability to support end-to-end development and manufacturing of RNA, DNA and gene therapy products starting from plasmids. .
Cloudbyz
APRIL 9, 2023
Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Clinical trials, in particular, have a significant impact on the environment, and it is essential to address this impact to ensure a sustainable future.
Cloudbyz
JUNE 16, 2023
Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.
Drug Discovery World
NOVEMBER 9, 2022
However, there is an increasing need to predict metabolism for other enzymes, such as human Aldehyde Oxidates (AOs), Flavin-containing Monooxygenases (FMOs), and Uridine 5’-diphosphoglucuronosyltransferases (UGTs). . The post AI development duo to advance drug-metabolising enzymes appeared first on Drug Discovery World (DDW).
Drug Discovery World
JANUARY 6, 2023
ISA103 was developed using the company’s Synthetic Long Peptide (SLP) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein. . A total of 90 patients will be enrolled in the trial. .
CTTI (Clinical Trials Transformation Initiative)
JANUARY 10, 2024
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.
Pharmaceutical Technology
SEPTEMBER 20, 2022
Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions. Clinical trial packaging and labelling solutions.
XTalks
MARCH 6, 2023
Levation Pharma has initiated a Phase I/II trial to evaluate the preliminary safety and potential efficacy of their investigational topical gel LEV102 for acquired blepharoptosis in adults. This is the first clinical trial that the company has launched for LEV102. What Will This Clinical Trial Evaluate? percent of adults.
Pfizer
FEBRUARY 16, 2023
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.
STAT News
SEPTEMBER 26, 2022
Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol.
Pharmaceutical Technology
JUNE 9, 2023
VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1%
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