European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. 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).

Medical 86

Medical Food and Drug Administration Pharmacology Medicine 86

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105

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

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

OCTOBER 10, 2022

The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD).

Pharmacology 59

Pharmacology Side effects FDA Safety 59