European Pharmaceutical Review

APRIL 13, 2023

Psychedelic research: evaluating the fast-evolving regulatory roadmap Psychedelics: the position in Europe The EMA’s recent letter confirms that as of 17 February 2023 in the EU, 6 there were: 11 ongoing clinical trials in EU with psilocybin for a range of central nervous system conditions four ongoing trials with MDMA one trial with LSD.

Medicine 114

Medicine Food and Drug Administration Doctors Government 114

Pharmaceutical Technology

MARCH 17, 2023

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. Digital therapeutics can be also categorised based on their regulatory journey.

Prescription 111

Prescription Pharmacology Pharma Medical 111

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). 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.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?

FDA