pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

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Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. Psychedelic products are having a renaissance moment. billion in 2027.

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pharmaphorum

AUGUST 19, 2021

Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license. Many guidelines focus narrowly on clinical trials (including non-randomized studies) that are intended to generate data for regulatory submission to support a new drug license.

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Cloudbyz

AUGUST 2, 2022

PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC). .

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pharmaphorum

AUGUST 16, 2022

Immunomedics had licensed the rights to the drug in Asian markets to Everest in 2019 for $65 million upfront and with up to $710 million in potential milestones, including $65 million due on US approval. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.

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Clinical Trial Podcast

JULY 18, 2020

This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical research space or simply curious about clinical trial costs, this post will serve you well. Clinical Research Assistants or Associates (CRAs). Patient Grant.

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XTalks

AUGUST 9, 2024

Technological advances, changing patient preferences and evolving guidance from regulators and policy makers have all supported new research methods that break down barriers to participation.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Rethinking Clinical Trials

JULY 6, 2023

There has been a growing sense of hesitancy about whether regulators will remain equally receptive to these decentralized methods when the pandemic recedes. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials.

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Velocity Clinical Research

AUGUST 18, 2023

Even as a teen in Egypt, Amira Nada was drawn to the idea of clinical research and how it could help people live healthier, richer lives. They weren’t getting the relief they needed, and I wanted to help change that,” Amira adds. She decided to focus on patient recruitment to promote diversity in clinical trial populations.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 31, 2024

Compliance and Security: Ensuring compliance with ever-changing regulatory guidelines is a critical concern in clinical trial management. Point systems complicate this task by requiring separate updates and validations to meet new regulations, a process that is both time-consuming and prone to oversights.

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ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. But the scope of risk extends beyond the tangible to more intangible areas such as organizational reputation and trust.

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Compliance Clinical Research Research Licensing 59

Advarra

APRIL 30, 2024

For example, non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

AUGUST 25, 2020

The regulator defines these mission-critical inspections as those that would impact US patients’ access to medical products used to treat, diagnose or prevent serious diseases for which there is no other option available. But drugmakers aren’t the only ones feeling the effects of fewer FDA inspections.

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XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

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XTalks

MAY 28, 2024

XTALKS CLINICAL EDGE: Issue 2 — CSL Seqirus’ Interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

Cloudbyz

AUGUST 2, 2022

PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC).

Marketing 52

Marketing Research Trials Clinical Trials 52

Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

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Clinical Trials Clinical Trials Trials Compliance 40

The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms. .

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Clinical Trials Clinical Trials Medicine Trials 52

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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The Pharma Data

AUGUST 31, 2021

The NICE recommendation was based on results from the Novartis ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels 7,8,9.

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Cloudbyz

AUGUST 16, 2024

Data is typically entered into an eCRF by clinical research staff, such as study coordinators or investigators, directly through a secure web-based interface. FDA regulations that establish the criteria for electronic records and electronic signatures. How do eCRFs support the integration of imaging data in clinical trials?

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Clinical Trials Clinical Trials Compliance Trials 52

pharmaphorum

SEPTEMBER 1, 2020

.” This public-spirited industry still required greater oversight, however, and government regulations on medicines increased on both sides of the Atlantic. Thalidomide and the development of drug safety regulation and monitoring. George Merck on the cover of Time magazine.

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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.

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The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Persons”, as such term is defined in Regulations under the U.S. PharmaDrug Inc.

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The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. “With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades.

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Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. • What does it mean for you?

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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

MAY 27, 2022

wearable device carried by patients to measure certain health-related parameters, remote patient monitoring) and tele-healthcare in clinical trials (e.g. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. video consultations), health data analytics (e.g. What comes next?

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The Pharma Data

NOVEMBER 22, 2020

Per the agreement between the foundation and Merck, the foundation, in its role as a funder, intends to provide grant funding to the International Clinical Research Center (ICRC) at the University of Washington Department of Global Health, which is collaborating with Merck on the IMPOWER 22 study. Merck’s Commitment to HIV.

Trials 52

Trials Clinical Trials Clinical Trials Production 52

pharmaphorum

MAY 26, 2022

A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines. This is underpinned by historical mistrust in healthcare organisations, governments, and clinical research, which is still prevalent in some communities.

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XTalks

MARCH 5, 2025

In the pivotal Phase III VERIFY study, researchers evaluated rusfertide, a firstinclass investigational hepcidin mimetic peptide therapeutic designed to mimic the natural hormone that regulates iron, to see if it could reduce the need for regular blood removals (phlebotomies).

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Elsewhere around the world: Avacta Group – U.K.-based Shanghai Haini Pharmaceutical — China’s Shanghai Haini Pharmaceutical Co.,

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