European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 million per approved drug. billion (3.3 Average NIH spending was $33.8

Food and Drug Administration 81

Food and Drug Administration Training Pharmaceutical Food 81

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Food and Drug Administration 98

Food and Drug Administration FDA Marketing Pharmaceutical 98

European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. USP-NF Propylene Glycol Monograph: USP43-NF38, 2010, 3753.

Food and Drug Administration 90

Food and Drug Administration Manufacturing Safety Food 90

World of DTC Marketing

APRIL 7, 2021

I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. drug spending by 9 percent” What about taxpayers? Highest-paid CEOs in 2019: Who made the list from healthcare.

Healthcare 162

Healthcare Healthcare Food and Drug Administration Pharma 162

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

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52