Pharmaceutical Technology

MAY 11, 2023

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. The regulator accepted and gr anted priority review for the sNDA in January 2023. Brexpiprazole was found to be well-tolerated and its safety profile was consistent with its known safety profile in other indications.

Food and Drug Administration 59

Food and Drug Administration FDA Pharmacology Safety 59

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. Available from: [link] [Last Accessed: 31st May 2023] Olsson F, Erridge S, Tait J, et al. Expert Review of Clinical Pharmacology.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

JULY 19, 2023

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

Pharmacology 98

Pharmacology Patients Safety Medicine 98

European Pharmaceutical Review

DECEMBER 11, 2023

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

Safety 98

Safety Pharmacology Engineering Medical 98

Impetus Digital

AUGUST 2, 2024

Looking back at 2023 , AI for drug discovery saw both wins and losses. To avoid compliance issues , it is essential to keep up with new regulatory changes, including updated reporting guidelines and safety requirements. In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%.

Pharma 95

Pharma Manufacturing Medicine Marketing 95

pharmaphorum

DECEMBER 22, 2022

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

Pharmacology 52

Pharmacology Safety Patients Marketing 52

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103