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
Containment Development Trials 
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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FDA suggests ways to curb constraints with rare disease gene therapy trials
Pharmaceutical Technology
FEBRUARY 8, 2023
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.
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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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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective
Pharmaceutical Technology
MAY 24, 2023
By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer
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.
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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: September 2021 Regulatory and Development Updates
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.
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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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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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Ghana becomes first country to approve Oxford’s malaria vaccine
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.
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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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Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials
Worldwide Clinical Trials
AUGUST 29, 2024
By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.
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FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials
pharmaphorum
JUNE 14, 2022
Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. China’s ambition to become a leader in the biopharma industry has been clear in the last few years.
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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Flow cytometry: advantages in immunotherapy clinical trials
Pharmaceutical Technology
AUGUST 24, 2022
Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Each sample they give is precious, as they all provide a wealth of biological data that contributes to therapy development. More complex panels provide information for exploratory assessment in clinical trials.
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Trial of Jazz’ cannabis drug in glioblastoma will start next year
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
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Novaliq’s dry eye disease therapy receives US FDA approval
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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Solving pharma’s process development challenges one API at a time
Pharmaceutical Technology
AUGUST 3, 2022
The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.
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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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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. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.
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AZ resumes UK coronavirus vaccine trial
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.
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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. Survival rates were also impressive, exceeding 90 percent at one year.
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Elon Musk’s Neuralink brain interface chip set for human trials
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.
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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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So much for pharma earning trust back
World of DTC Marketing
NOVEMBER 27, 2020
Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.
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FDA clears Pfizer’s PREVNAR 20 vaccine for IPD prevention
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.
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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.
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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Is the microbiome therapy hype up for a reckoning?
Pharmaceutical Technology
FEBRUARY 26, 2023
Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.
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No drugs for prions: could new approaches alleviate therapeutic scarcity?
Pharmaceutical Technology
AUGUST 5, 2022
The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials.
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Meningitis vaccine comes to the forefront with impressive study results
Pharmaceutical Technology
MAY 25, 2023
A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile.
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Predicting and improving clinical trial enrolment: A problem for psychiatry
pharmaphorum
AUGUST 6, 2021
Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these important trials. .
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Interview About Decentralized Oncology Trials with Devon Adams, Senior Analyst at the ACS CAN
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.
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US FDA clears Transcenta’s IND for Rett syndrome treatment
Pharmaceutical Technology
JANUARY 24, 2023
Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.
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Polyrizon IPO Strengthens Momentum in Non-Invasive Drug Delivery Solutions
XTalks
NOVEMBER 5, 2024
per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D).
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CSL doses first patient with haemophilia B gene therapy Hemgenix
Pharmaceutical Technology
JUNE 21, 2023
This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891). Hemgenix works by dosing a patient with an engineered adeno-associated virus (AAV), containing the gene responsible for producing a protein called factor IX. Once administered, the body will then be able to produce factor IX and prevent severe bleeds.
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Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 Variant Shared by Protein Vaccine Maker
XTalks
MAY 7, 2021
Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Earlier results from a more complete analysis of trial data shared in March confirmed a high level efficacy of 86.3 1.351 variant.
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Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial
XTalks
APRIL 29, 2022
Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. GLP-1 agonists were first developed as diabetes treatments. percent and 22.5
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ESMO 2022: the evolution of TIL therapy – a highly promising approach
Pharmaceutical Technology
SEPTEMBER 14, 2022
Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. While this approach is in the early stages of development, it is an exciting avenue of research.
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Merck wins regulatory approval for combination therapy to treat la/mUC
Pharmaceutical Technology
APRIL 4, 2023
KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen. The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. The trial was jointly conducted by Seagen and Astellas.
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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. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.
Top 30 New Medical Devices of 2024
XTalks
JANUARY 21, 2025
TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.
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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. Clinical trial packaging and labelling solutions.
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