pharmaphorum

MARCH 25, 2022

As few as 2% have peer-reviewed research to back up their claims. ”. These analyses focused exclusively on wellness and smoking cessation apps, bypassing a category of digital therapeutics regulated by the FDA that make scientifically validated claims using sound research. Consistent Standards Matter.

Production 115

Production Regulation Research Clinical Research 115

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.

Compliance 59

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. associates, residents, research fellows). Sites outside of the U.S.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

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.

Licensing 52

Licensing Licensing Hormones Drugs 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.

Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Compliance 40

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.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

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?

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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. The earlier HTAs, researchers and pharma companies can start that engagement the better.

Drugs 105

Drugs Pharma Companies Licensing Licensing 105

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. Even still, these approved drug products require a licensed healthcare provider’s prescription. What is the regulatory landscape of medical cannabis?

Medicine 52

Medicine Scientist Production Regulation 52

Clinical Trial Podcast

JULY 18, 2020

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. 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 Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

DECEMBER 14, 2020

Authors of “ An ethical exploration of barriers to research on controlled drugs ” in the American Journal of Bioethics have been quoted stating, “the classification of drugs as Schedule I amounts to an unsurmountable barrier to research.” For further information please visit www.abetterlifephama.com.

Drug Delivery 40

Drug Delivery Containment Manufacturing Drugs 40

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.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

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. DKMA called ensuring sufficient safety monitoring “one of the most significant challenges of decentralized clinical trials today.” EMA Report. .

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Research and development efforts will be led by Dr. Paul Van Slyke. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

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.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Medicine 143

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?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

Clinical Trials 85

Clinical Trials Clinical Trials Trials Compliance 85

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. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal.

Trials 98

Trials Gene Hormones Clinical Trials 98

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. How Can Research Professionals Mitigate Risks with Engineered Genetic Materials?

Gene Therapy 52

Gene Therapy Development Gene Drugs 52

pharmaphorum

SEPTEMBER 1, 2020

The war had also encouraged research into everything from new analgesics to drugs against typhus, with a great deal of collaboration between the companies and government. ” This public-spirited industry still required greater oversight, however, and government regulations on medicines increased on both sides of the Atlantic.

Medicine 145

Medicine Insulin Pharmacy Drugs 145

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. What are the major challenges you’re facing right now in vaccine development?

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

Drug Discovery World

FEBRUARY 20, 2023

AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. The approval was based on results from the PROpel Phase III trial, however, the drug was rejected by UK regulator NICE because it requires expensive genetic testing.

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

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.,

Drugs 52

Drugs Licensing Licensing Vaccination 52

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. Source link: [link].

Containment 52

Containment Production RNA Medicine 52

Drug Discovery World

FEBRUARY 22, 2024

Recent advances in biomarkers, research into the central nervous system and breakthroughs in human iPSC cell models, have bolstered neuroscience drug discovery research. ARUK 3 adds that while the UK government increased funding in dementia research from £28.2m years it takes to complete an entire cancer clinical trial.

Drugs 59

Drugs Gene Clinical Trials Clinical Trials 59

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Merck’s Commitment to HIV.

Trials 52

Trials Clinical Trials Clinical Trials Production 52