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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.

EU Merger Control: Neuberger/Ares/Onex/Founder/Ryan Decision

The European Commission has published its decision on merger case M.12322, concerning the acquisition of joint control of Ryan by Neuberger, Ares, Onex, and G. Brint Ryan. The Commission has decided not to oppose the notified operation, declaring it compatible with the internal market.

EU Commission Approves Apollo Funds / Lecta Merger

The European Commission has issued a decision granting non-opposition to the proposed concentration between Apollo Funds and Lecta. This decision, made under the EU Merger Regulation, signifies the Commission's approval of the acquisition.

EU Closes State Aid Investigation for Peugeot Investment

The European Commission has closed its formal investigation into State aid concerning a regional investment project for Peugeot Citroën Automóviles España, S.A. The closure follows a withdrawal by the Member State, Spain, and relates to aid under Articles 107 to 109 of the TFEU.

NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer

NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.

Canagliflozin Appraisal Terminated for Type 2 Diabetes in Youth

NICE has terminated the appraisal of canagliflozin (Invokana) for treating type 2 diabetes in individuals aged 10 to 17 years. The appraisal was terminated because the company failed to provide an evidence submission. NICE will review this decision if a submission is made.

Baloxavir marboxil appraisal terminated for children

NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.

USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph

The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.