Remove Food and Drug Administration Remove Healthcare Remove Safety
article thumbnail

Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

Safety 94
article thumbnail

Should we be worried about pharma’s supply chain?

World of DTC Marketing

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.

article thumbnail

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

FDA 207
article thumbnail

Roche subcutaneous cancer immunotherapy granted MHRA approval

European Pharmaceutical Review

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

article thumbnail

FDA approves first cell-based gene therapies for sickle cell disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved two landmark cell-based gene therapies for treatment of inherited blood disorder sickle cell disease. Additionally, patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness.

article thumbnail

International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

article thumbnail

Encouraging data for Roche multiple sclerosis injection

European Pharmaceutical Review

These results demonstrate the potential of subcutaneous OCREVUS as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals,” Newsome added. Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection.