Pharma & Life Sciences

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.

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.

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.

Carbachol Monograph Revision - Assay Criteria

The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.

USP Notice: Revision to Sennosides Tablets Monograph Testing Method

The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.

Dapagliflozin Tablets Monograph Revision Notice

The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.

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.

CMS Extends GENEROUS Model Application Deadline

The Centers for Medicare & Medicaid Services (CMS) has extended the application deadline for the GENEROUS Model, a drug pricing initiative for Medicaid, from March 31, 2026, to April 30, 2026. This extension provides additional time for prescription drug manufacturers to apply to participate in the model, which aims to lower drug spending and improve health outcomes.

Medicare.gov Enhanced Login Options

The Centers for Medicare & Medicaid Services (CMS) has introduced new login options for Medicare.gov, including ID.me, CLEAR, and Login.gov, to enhance user security and protect beneficiary information from fraud and identity theft. These services are free and offer various verification and support methods.