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
October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs
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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Streamlining development with containment in early drug discovery
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.
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EMA sets out proposals to reform EU’s clinical trials framework
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.
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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery
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.
Kite and Arcellx enter partnership for multiple myeloma therapy development
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.
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Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development
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.
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ChatGPT in Clinical Trials: How to address data privacy and data protection concerns
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.
Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility
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. Effectively managing and storing such large datasets presents logistical challenges.
CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov
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.
Reducing Environmental Impact in Clinical Trials: Best Sustainable Practices
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.
Biologic CAR T cell engager approved for UK clinical trial
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.
Innovations in Heart Failure Management Through Cardiovascular Device Development
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.
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Acquired Blepharoptosis: Levation Pharma Launches Clinical Trial
XTalks
MARCH 6, 2023
This is the first clinical trial that the company has launched for LEV102. Acquired blepharoptosis develops later in life, while congenital blepharoptosis is present at birth. LEV102 is an aqueous topical gel that contains a drug called oxymetazoline, which is used in medications to treat nasal congestion and sinus pressure.
Predicting and improving clinical trial enrolment: A problem for psychiatry
pharmaphorum
AUGUST 6, 2021
Psychiatric disorders have historically had great difficulty onboarding and retaining patients for clinical trials. Major depression is one of the most prevalent and debilitating disorders which, in a 2015 review, showed a drop-out rate of almost 20% across 45 randomised clinical trials.
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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey
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.
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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15
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. FDA in July 2017.
The Utility of Liquid Biopsy in Oncology Clinical Trials
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. How personalized, targeted assays can be developed to detect somatic mutations from cfDNA. “A
Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics
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.
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Medicinal cannabis: Why more clinical trials and better access is needed
Drug Discovery World
FEBRUARY 1, 2023
But more robust studies are needed across the board to help with the discovery and development of cannabis-based pharmaceuticals. Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace.
In the News: November 2021 Regulatory and Development Updates
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. Voxzogo’s approval was based on an intermediate clinical endpoint (though accelerated approvals can also come from surrogate endpoints ).
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Leading clinical packaging companies in contract marketing
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.
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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials
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.
MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience
The Pharma Data
JANUARY 13, 2021
. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.
In the News: October Regulatory and Development Updates
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.
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In the News: May 2021 Regulatory and Development Updates
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.
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Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
Advarra
FEBRUARY 24, 2023
One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.
Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
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.
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In the News: December 2020 Regulatory and Development Updates
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.
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Yapan Bio expands to a new process development facility in India
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. .
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Opinion: Subject, not suspect: The new hazards of conducting clinical research in the Dobbs era
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.
SolasCure secures £10.9m funding to develop Aurase Wound Gel
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).
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Development of Oncology Therapies – Tips from the FDA to Drive Success
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. Oncology therapies typically have a comparatively shorter lab-to-clinic turnaround time than therapeutics targeting other diseases.
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Drug development practices to improve public health policy
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. At times, this proved a major roadblock during Covid-19, where similar datasets contained unexplained differences and inconsistencies. Pre-specification of effect size .
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Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy
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.
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ASLAN Pharmaceuticals Opens Expansion Cohort in ASLAN004 Atopic Dermatitis Clinical Trial
The Pharma Data
JANUARY 10, 2021
Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements. SINGAPORE, Jan. Forward looking statements.
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
Advarra
OCTOBER 4, 2023
When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.
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Cantex secures license to develop small molecule-drug for inflammatory lung diseases
pharmaphorum
FEBRUARY 24, 2022
Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.
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Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency
The Pharma Data
JANUARY 3, 2021
. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.
The ABCs of Transitioning PK Assays from Preclinical to Clinical
Worldwide Clinical Trials
SEPTEMBER 29, 2022
In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. If so, it’s important to plan for development of this assay as within the project timeline. As such, they employ high dosages, so most samples contain highly concentrated drug levels.
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Leading clinical dose companies in contract marketing
Pharmaceutical Technology
SEPTEMBER 14, 2022
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.
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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2
Camargo
SEPTEMBER 14, 2021
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. In this second installment, we compare applications for conducting clinical studies, expedited programs, pediatric plans, and labeling in the US and EU markets.
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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials
The Pharma Data
JULY 8, 2021
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.
Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine
The Pharma Data
APRIL 3, 2021
The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.
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