World of DTC Marketing

APRIL 20, 2022

This was especially true with new drugs that have a significant competitive market. Trust in pharma did not decline, but they don’t want to be told about the data via charts; they want the ability to read the data for themselves and talk to other HCPs about the data and drug.

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Marketing Drugs Drug Trials Sales 218

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

AUGUST 6, 2020

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.

Drug Trials 52

Drug Trials Trials Drugs Development 52

STAT News

DECEMBER 2, 2022

And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Dermatology 98

pharmaphorum

AUGUST 25, 2022

That is a moral failure on the part of medicine. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. Dozens of companies are working at various stages of drug development.

Development 98

Development Drugs Trials Medicine 98

NY Times

FEBRUARY 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy. population.

Drugs 58

Drugs Drug Trials Trials Clinical Trials 58

Scienmag

JULY 8, 2021

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.

Trials 68

Trials Drug Trials Drugs Research 68

pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.

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Clinical Trials Clinical Trials Trials Vaccination 122

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmacovigilance refers to the practice of collecting, detecting, assessing, monitoring and preventing adverse effects (AEs) caused by new drug substances. To meet the challenges caused by the Covid-19 pandemic, RWS integrated machine translation (MT) technology into its workflow.

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Engineer Production Medicine Trials 130

Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. Why the Need?

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Clinical Trials Clinical Trials Trials Drugs 98

pharmaphorum

DECEMBER 1, 2022

According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. The fact is, many minorities never learn about vital clinical trials in play, or that they’re eligible to participate. Keep it simple.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Drugs 52

Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

AUGUST 16, 2020

“Historically medical education was designed and written by white middle-class men, and so there is an inherent racism in medicine that means it exists to serve white patients above all others,” he said. Teaching on the history of medicine, including the exploitation of people of colour in scientific research.

Doctors 52

Doctors Doctor Medicine Drug Trials 52

Placebo Control

JULY 14, 2015

pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. Unbelievable but true if #Path2Cures becomes law.

Trials 40

Trials Clinical Trials Clinical Trials Manufacturing 40

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished. 1001566.

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Trials Clinical Trials Clinical Trials Containment 40

XTalks

FEBRUARY 25, 2022

Despite these statistics, in the US, Black people only constitute five percent of all clinical trial participants. The overwhelming majority of trial participants nationwide are white. Race-Based Medicine. Personalized Medicine. However, the links between race-based genetics and disease are not quite clear.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

XTalks

AUGUST 4, 2022

The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. or greater than 1.2

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

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Manufacturing RNA Contamination Vaccination 130