European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. billion in 2022, a product that was launched in 2002. This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

Marketing 83

Marketing Food and Drug Administration Food Medicine 83

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. The drug is currently under review in Australia, the EU and Switzerland.

FDA 97

FDA Food and Drug Administration Food Pharmaceutical 97

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

Lorrie Vuolo-Schuessler has been involved with ISPE and the GAMP © Community of Practice leadership since 2002 and is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global Leadership Team. FDA, Computer Software Assurance for Production and Quality System Software – Draft Guidance. FDA, 2022. .

Manufacturing 89

Manufacturing Pharma Food and Drug Administration Safety 89

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. The research also identified other challenges for mRNA therapeutics’ delivery , including their high cost, susceptibility to degradation by ribonucleases and limitations with drug delivery systems.

Food and Drug Administration 95

Food and Drug Administration Medicine Safety Consulting 95

World of DTC Marketing

MARCH 17, 2022

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. sustaining life)?

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255