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HSA Deepens International Partnerships for Biomedical Sector Growth

The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.

Pflaumer et al v. ACE Hardware Corporation - Civil Case Filing

A new civil case, Pflaumer et al v. ACE Hardware Corporation, has been filed in the U.S. District Court for the Northern District of California. The case, bearing number 5:26-cv-02151, was filed on March 12, 2026, with a filing fee of $405. The initial filings include the complaint, proposed summons, and a certificate of interested entities.

NICE Guidance: Pegzilarginase for Arginase-1 Deficiency

NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.

Cerliponase alfa for Neuronal Ceroid Lipofuscinosis Type 2 Guidance

NICE has published updated highly specialised technologies guidance (HST34) on cerliponase alfa (Brineura) for treating neuronal ceroid lipofuscinosis type 2 in children. This guidance replaces previous guidance and confirms that patients already receiving treatment can continue.

NICE Guidance: Leniolisib for PI3K delta syndrome

NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.

NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B

NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.

NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

Merger Decision M.12287 TPG / Vitality / SoftBank / Cambridge Mobile Telematics

The European Commission has approved the proposed concentration in Case M.12287, involving TPG, Vitality, SoftBank, and Cambridge Mobile Telematics. The decision, adopted under Article 6(1)(b) of the Merger Regulation, signifies non-opposition to the joint control acquisition.