article thumbnail

Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

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.

article thumbnail

The future of medical cannabis development in Europe

European Pharmaceutical Review

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 79
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Efficacy of novel drug proven in MDD study

European Pharmaceutical Review

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.

article thumbnail

Pfizer files blockbuster hope etrasimod for ulcerative colitis

pharmaphorum

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.

article thumbnail

Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

By collaborating with several stakeholders and authorities, multiple stages of development can take place concurrently to speed up R&D without compromising safety protocols. cited 2023 Apr 4]. 2019 [cited 2023 Apr 4]. cited 2023 Apr 4]. cited 2023 Apr 4]. cited 2023 Apr 4]. 2023 [cited 2023 Apr 4].

article thumbnail

Developing new treatment regimens for HIV

European Pharmaceutical Review

In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. Internet] 2023. References 1. World Health Organization.

article thumbnail

Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

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.