European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

Pharmaceutical Technology

MARCH 22, 2023

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, various global administrators have issued regulatory standards.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma Pharmaceutical products 105

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. World Health Organization; 2006. Fake drugs kill more than 250,000 children a year, doctors warn.

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. Building on these 4R’s, we designed the Phase III Clarity AD study in order to definitively assess the safety and efficacy of lecanemab.

Food and Drug Administration 96

Food and Drug Administration Safety Medicine Pharmaceutical 96

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

World of DTC Marketing

MAY 6, 2021

Some say pharma should be allowed to make as much as they want because we live in a capitalist society but JAMA recently found out that price increases in branded drugs means that people will often go without their medications. But what about the costs to develop new drugs and the failure rates?

Pharma 185

Pharma Food and Drug Administration Government Insurance 185