European Pharmaceutical Review

JULY 13, 2023

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). Expert Review of Clinical Pharmacology. Plant cannabinoids: a neglected pharmacological treasure trove. British journal of pharmacology. 2005 Dec;146(7):913-5. Mechoulam R.

Medical 86

Medical Food and Drug Administration Pharmacology Medicine 86

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs.

Food and Drug Administration 76

Food and Drug Administration Pharmaceutical products FDA Pharmacology 76

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78