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FDA warning letters, drug approvals, ICH guidelines, EMA updates, and DEA scheduling.
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Trade & Procurement
Recent changes
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 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.
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.
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.
NICE Guidance on Bevacizumab for Metastatic Colorectal Cancer (TA1136)
NICE has published updated technology appraisal guidance (TA1136) on the use of bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer. This guidance replaces previous recommendations and provides evidence-based recommendations for healthcare professionals.
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.
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.
NICE Guidance: Epcoritamab for Follicular Lymphoma
NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.
Medicare and Medicaid CY 2026 Payment Policies Correction
The Centers for Medicare & Medicaid Services (CMS) issued a correction to the Calendar Year 2026 payment policies under the Physician Fee Schedule and other changes to Part B payment and coverage policies. This correction addresses specific aspects of the previously published rule concerning Medicare and Medicaid programs.
Adapalene Monograph Revision Proposed for Solubility Issue
The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.
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