Data Dose August 2024 #3

Nuvation Bio pauses oncology drug after Phase I efficacy and safety analysis

Nuvation Bio has announced a pause in the development of its oncology drug NUV-868 following a safety and efficacy analysis from a Phase I trial in solid tumors. After conducting an internal review of the efficacy and safety data from the Phase I monotherapy and Phase Ib combination studies of NUV-868, the company decided not to proceed to Phase II at this time. Phase II would have assessed NUV-868 as a monotherapy or in combination with olaparib or enzalutamide for advanced solid tumors, as investigated in the Phase I and Ib trials. Read more...

More oversight needed of unapproved medicines that threaten patients’ health

The recent surge in marketing and selling knockoff versions of innovative diabetes and anti-obesity medicines is raising significant patient safety concerns. An investigation by Vanity Fair exposed the chaotic landscape of deceptive telehealth companies and compounding pharmacies flooding the market with these knockoffs, leading to potentially disastrous consequences for patients. Reuters reported that one security firm has taken down 250 websites selling fake versions of these medicines. Although it's challenging to quantify the market size due to the lack of regulation comparable to FDA-approved medicines, Bloomberg estimates that the annual demand for compounded weight loss drugs could exceed $1 billion. Read more...

Falsified (contaminated) Oxymorphone Hydrochloride 40mg identified in the WHO Region for Europe

This WHO Medical Product Alert concerns a batch of falsified Oxymorphone Hydrochloride 40mg detected in Finland's unregulated supply chain, reported by the Finnish Medicines Agency (FIMEA) in July 2024. Oxymorphone Hydrochloride, a semi-synthetic opioid for moderate to severe pain, was found in laboratory analysis to contain metonitazene instead. Metonitazene is a potent synthetic opioid with no recognized medicinal use, classified as a Schedule I narcotic drug. Even small doses can cause serious adverse effects like respiratory depression, severe sedation, addiction, and potentially fatal overdose. Read more...