Camargo

OCTOBER 20, 2021

From the regulator’s point of view, combination products are not restricted to combined biologics, drugs, and/or devices formed into a single entity (like a drug-eluting coronary artery stent). This will benefit both the FDA and the sponsor in a win-win situation.

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Production Regulation Drugs Development 206

Pharma Mirror

FEBRUARY 6, 2024

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments.

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Production Packaging Packaging Clinical Research 100

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. The first is a lack of standardisation in trial design, which leads to delays in study setup. The future is automation.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. First-in-human trial. Scope and design of definitive animal trials and clinical trials.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

pharmaphorum

APRIL 11, 2022

Chris Garabedian, CEO of Xontogeny, describes how his past experiences as CEO of Sarepta Therapeutics have led him on an exploration for technology that can effectively leverage wearable data in clinical trials. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”.

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Clinical Trials Clinical Trials Trials Development 111

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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Production Regulation Manufacturing Packaging 98

Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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Cloudbyz

AUGUST 15, 2024

Randomization and Trial Supply Management (RTSM) play a pivotal role in the successful execution of clinical trials. As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Clinical Trial Podcast

FEBRUARY 23, 2021

Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. The reason why the project management role is so interesting is because it provides a holistic view of clinical trial management and clinical research. They are accountable of all aspects of a clinical trial.

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Clinical Research Research Clinical Trials Clinical Trials 105

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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Pharmaceutical Technology

AUGUST 30, 2022

Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis.

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Manufacturing Marketing Pharma Companies Vaccine 195

pharmaphorum

JULY 22, 2021

We have completed phase 2 trial of a multi-antibody drug for influenza, CT-P27, and since 2015 we have been developing a therapeutic antibody to treat the Middle East Respiratory Syndrome (MERS), CT-P38. All of our processes, and also those of the entire healthcare ecosystem, including regulators, had to be accelerated.

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Antibody Clinical Trials Clinical Trials Trials 105

pharmaphorum

DECEMBER 10, 2021

Intercept had been hoping to extend the review period in the EU to allow time for results from an ongoing to phase 3 trial to come in, now due in the first quarter of next year, but conceded defeat yesterday. The post Intercept’s travails continue as it pulls NASH drug filing in EU appeared first on.

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Drugs Sales Marketing Packaging 98

Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Cost: Manufacturing cell and gene therapies can be expensive, especially for small patient populations, which can impact the overall viability of a trial.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

The Pharma Data

JULY 11, 2021

Mirikizumab is being studied in Phase 3 trials for UC and Crohn’s disease (CD), two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life. Mirikizumab Showed Early and Sustained Gene Expression Changes Associated with Mucosal Healing in UC for Up to One Year.

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Regulation Gene Gene Expression Packaging 52

Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

XTalks

AUGUST 29, 2022

Based on these findings, Cytimmune will be moving these candidates into early clinical trial testing. Several different candidates using nanotechnology to target cancer have been approved by the US Food and Drug Administration (FDA), and many more are being evaluated in clinical trials. What Are Nanomedicines?

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Clinical Trials Clinical Trials Trials Drugs 95

Camargo

JANUARY 19, 2021

However – particularly in rare disease programs with only one Phase 3 trial, often of short duration – sponsors many times find themselves ready to file clinical data before completing the minimum 12 months of stability testing on the to-be-marketed finished product and API. Having a quality agreement in place is critical.

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Production Branding Contract Manufacturing Manufacturing 135

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. The rapidly expanding landscape of cell therapy trials has put an operational strain on many clinical sites due to limited resources and infrastructure. “In

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

pharmaphorum

JANUARY 28, 2021

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .

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Packaging Packaging Clinical Trials Clinical Trials 52

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . The IND goes into effect; and .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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Marketing Sales Manufacturing Drugs 130

Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. The short answer: No.

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Compliance Regulation Packaging Packaging 52

pharmaphorum

NOVEMBER 11, 2022

These center on ascertaining the product value for stakeholders, identifying the right trial design, understanding the data to collect outside of clinical trials, and when to engage clinicians and patients with the right messages to shift the standard of care. Many therapies will be first in class with novel modes of action.

Clinical Development 52

Clinical Development Marketing Regulation Packaging 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Clinical Trials Trials Compliance 40

pharmaphorum

APRIL 21, 2021

Hikma had to start a whole new trial to answer the FDA’s questions following a rejection in 2017 and then had to put its launch on hold this year while the regulator reviewed a packaging update. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Packaging Packaging Sales Production 59

FDA Law Blog

DECEMBER 7, 2022

However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies. We can see this evolution for requiring longer-term follow-up play out with this most recent approval of Hemgenix.

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Gene Therapy Gene FDA Approval Production 119

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. The UDI was FDA’s risk-based approach to regulate the hundreds (possibly thousands) of illegal drugs that remain on the U.S.

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Development Production Drugs Marketing 130

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

Marketing 52

Marketing Compliance Packaging Packaging 52

XTalks

NOVEMBER 23, 2021

The expansion will include a new 30,000-square-foot building that will be able to produce 160 million doses of an mRNA vaccine per year, and up to 70 million prepared and packaged fill finish doses for commercial distribution annually. Additional production would be performed at other facilities for final packaging.

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Manufacturing Vaccination Vaccine Drugs 98

Camargo

JULY 30, 2021

They immediately stood up and said, “No, we’re doing six clinical trials in pediatrics now, specifically in the infant population, for something called pulmonary hypertension in these kids.” But now it’s a warning in their package insert. There were six Pfizer people in the audience.

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Clinical Research Research Gene Therapy Drugs 226

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program. About PRISYM ID. Media Contact: Andrew Baud, Distil,?

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 24, 2020

The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. The news comes after China said that companies and organisations must prove to regulators that vaccines have 50% efficacy. Conor Kavanagh. Source link.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52