European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer licensed BEQVEZ from Spark Therapeutics in December 2014.

Food and Drug Administration 96

Food and Drug Administration Medicine FDA Food 96

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

JULY 26, 2024

DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year. The pharmaceutical company licensed the gene therapy DURVEQTIX from Spark ® Therapeutics in December 2014.

Food and Drug Administration 52

Food and Drug Administration Engineering Food Patients 52

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute will lead the project.

Food and Drug Administration 98

Food and Drug Administration Medicine Training Electronics 98

Clarivate

SEPTEMBER 11, 2024

Approximately 43% of people with MCI develop dementia due to Alzheimer’s disease within 5 years (Roberts, 2014) (Figure 1). Currently, of the eight drugs approved by the U.S. Food and Drug Administration, 2023 and 2024). Food and Drug Administration, n.d.), In 2022, the U.S.

Food and Drug Administration 59

Food and Drug Administration Pharmacology Food FDA 59

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). This could lead to significant research waste.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98