Pharmaceutical Technology

APRIL 27, 2023

The CHMP used evidence from a Phase III trial ( NCT03729362 ) involving 123 patients with late-onset Pompe Disease (LOPD) to adopt a positive opinion for Opfolda. Sanofi markets avalglucosidase alfa as Lumizyme in the US to treat LOPD since its approval in 2010. A decision from the European Commission (EC) is expected in Q3 2023.

Food and Drug Administration 52

Food and Drug Administration Food Marketing Medicine 52

Clarivate

MAY 21, 2024

Given its clinical robustness and patient relevance, OS is universally accepted by regulators and health technology assessment (HTA) bodies alike [2] [3]. Measurement of OS is also susceptible to confounding, particularly when involving multiple lines of therapies, patient crossover, and the occurrence of non-cancer related deaths.

Food and Drug Administration 52

Food and Drug Administration Patients Consulting Marketing 52

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

Pharma 105

Pharma Food and Drug Administration Medicine Government 105

World of DTC Marketing

APRIL 7, 2022

Obesity costs our health care system $147 billion per year, yet there is a movement underway to tell HCPs not to weigh patients during routine visits. The seventh leading cause of death in the United States, diabetes costs $327 billion in medical costs and lost work and wages. Launch prices of new cancer drugs in the U.S.

Healthcare 215

Healthcare Healthcare Food and Drug Administration Government 215

Pharmaceutical Technology

MAY 18, 2023

Add in complex trial protocols, and many participants have reported feeling a lack of patient engagement and support [i]. Other processes include direct-to-patient (DtP) shipments of drugs and other supplies to a patient’s home, as well as in-home care with mobile nurses. of all terminated trials.

Recruitment 52

Recruitment Food and Drug Administration Patients Media 52