1. FDA places planned pediatric BMB-101 epilepsy trial on partial clinical hold
Bright Minds Biosciences announced on 2 November that FDA has placed its IND for developmental and epileptic encephalopathies (DEEs), and the planned phase 2 protocol BMB-101-105, on partial clinical hold. According to the company, FDA's main reasons are toxicity identified in mice and inadequate pharmacokinetic and juvenile toxicity data to support the proposed pediatric enrollment. The company says the mouse findings were not seen in other species and considers them incidental, and it believes its other ongoing trials are unaffected; the full hold letter is expected within 30 days. The case is a reminder that a nonclinical package designed for adults may not be enough once a programme moves into children, and that juvenile toxicity and pediatric PK planning belong in the safety strategy before the protocol is filed. Bright Minds Biosciences press release, 2 Nov 2026
2. Swissmedic November Safety Update: pancreatitis, Fournier's gangrene and radiation damage
Swissmedic's monthly overview of safety-related product information changes, updated on 1 November, lists new information for several substances and classes. Highlights include severe hypertriglyceridaemia with resulting acute pancreatitis for alectinib (with triglyceride monitoring, discontinuation if it occurs, and a DHPC for Alecensa), necrotising pancreatitis for GLP-1 receptor agonists, Fournier's gangrene for SGLT2 inhibitors, and potentiation of radiation damage for dabrafenib and trametinib. Aflibercept receives several new warnings on intravitreal injection complications, intraocular pressure and bilateral treatment. Marketing authorisation holders of generics should note that their product information will follow the originator updates. Swissmedic Safety Update, 1 Nov 2026
3. #MedSafetyWeek 2026 starts, with a focus on AI-related adverse events in the UK
The eleventh #MedSafetyWeek runs from 2 to 8 November 2026 under the theme "Don't ignore suspected side effects, report them", with more than 130 organisations from over 120 countries taking part. The MHRA used the launch to remind patients and healthcare professionals that only a suspicion is needed to submit a Yellow Card, and that reports also cover medical devices, including software, apps and artificial intelligence. It also launched a national essay competition on detecting and reporting AI-related adverse events. For safety teams, campaign weeks like this can briefly raise spontaneous reporting volumes, which is worth keeping in mind when reviewing disproportionality or trend data for the period. MHRA press release, 2 Nov 2026
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