FDA draft guidance on non-opioid pain treatments

FDA issues draft guidance to accelerate nonopioid chronic pain treatments The new guidance focuses on: ✅ Efficient trial design and patient selection ✅ Meaningful endpoints and patient-reported outcomes ✅ Mechanistic evaluation of drugs and chronic pain conditions This effort aims to reduce reliance on opioids and support safer, effective therapies for millions living with chronic pain. Stakeholders can submit feedback for 60 days. Full details: https://lnkd.in/e3avGdAE #ChronicPain #PainManagement #NonOpioid #FDAGuidance #PatientCare #ClinicalTrials #PublicHealth

Same-Day Re-Draw/Re-Dose Loops: The Fastest Way to Protect Patients and Payment In home infusion, waiting until tomorrow is often too late. When drug levels shift, delaying a dose adjustment means three bad things: ❌ Higher risk of kidney injury (nephrotoxicity) ❌ Greater chance of treatment failure ❌ Claims that get denied for lack of clinical necessity. The fix? Build a same-day re-draw/re-dose loop: if a lab result shows levels are off, redraw the level, recalc the dose, and re-dose the same calendar day. This isn’t just best practice—it’s standard of care for vancomycin (AUC-guided) and aminoglycosides, where therapeutic drug monitoring (TDM) is everything. Read more at https://lnkd.in/e42u4QmA

A medication is only as good as adherence. This is hardly a surprising result: patients less likely to be completely adherent to more complicated regimens. But it's something worth repeating in the medical community. It's so easy on the messaging side to forget that patients have busy lives too, and every additional medicine imposes a burden. It's why "convenience" is a cornerstone of Quill Science's messaging strategy. #Diabetes #MedicationAdherence #Medicine #MedComms https://lnkd.in/gCYg7q_k

CMS recently granted pass-through status to PET (positron emission tomography) product Gozellix from Australian drugmaker Telix Pharmaceuticals. This enables separate reimbursement for the radionuclide diagnostic agent under the Hospital Outpatient Prospective Payment System (HOPPS). 

A medication is only as good as adherence. This is hardly a surprising result: patients less likely to be completely adherent to more complicated regimens. But it's something worth repeating in the medical community. It's so easy on the messaging side to forget that patients have busy lives too, and every additional medicine imposes a burden. It's why "convenience" is a cornerstone of Quill Science's messaging strategy. #Diabetes #MedicationAdherence #Medicine #MedComms https://lnkd.in/gWgWthu9

Okay, let’s talk about direct-to-patient prescription models. This came up in every one of my calls yesterday since a handful of psoriasis / eczema medications launched direct-to-patient options this week. I'm being asked how this wave will affect Zest and the broader future of value-based pharmacy. Alternative models provide patients with more options for accessing medication - but having built Zest Health, I’ve seen firsthand how much thoughtful clinical work is needed to support patients on biologic therapies or even manage symptoms for topicals. Accessing medication isn't the same as accessing care. Direct-to-patient prices are still wildly expensive, and these patients may not receive the right education, monitoring, and navigation to get the most out of these therapies and get the value they paid for. Without appropriate clinical support, we risk creating more cost, waste, and inequity - precisely the issues that value-based care models like Zest aim to solve.

Solving the surgeon’s dilemma – Dr. Dempewolf discusses how using H-Wave with is patients post-operatively helps reduce opioid usage. This scientifically proven, drug free alternative not only relieves pain, but also helps patients achieve long-lasting, rehabilitative benefits. #HWave #OpioidReduction #PostOp

As of Q2 2025, our Patient Access Tracker estimates that 41,734 patients have been treated with approved CAR T-cell therapies since 2017.   While the number of patients treated is increasing, manufacturing capacity remains a significant barrier. Meeting this growing unmet need requires scalable and flexible platforms – like the FDA AMT-designated IRO® platform – that prioritize patient access goals from the start. Read the latest patient access numbers ➡️ https://lnkd.in/esRFEQvq Disclaimer: These numbers are inferred from publicly reported revenue numbers and are directionally correct but may not be precise. They don't account for patients previously treated in clinical trials or on compassionate use.

In June 2025, the FDA lifted the special REMS programs for all currently approved CAR-T therapies used in blood cancers. In practice, this reduces the administrative burden on treatment centers and can help streamline care. Safety guidance remains through boxed warnings, product labeling, and routine monitoring. Jakob Reiser, Ph.D., Senior Director of Regulatory Affairs, shared his perspective in Specialty Pharmacy Continuum: “This move will likely increase access to CAR-T therapies and streamline treatment, while still ensuring patient safety through ongoing monitoring and labeling requirements.” It’s an encouraging step toward greater access to cures for patients in need. At Vector BioMed, we’re glad to see this progress, as it reflects our own mission and ethos. We’re excited to see how it helps more patients benefit from these transformative therapies. Read the full article: https://lnkd.in/gDerufsQ #CGT #GeneTherapy #LentiviralVectors #AdvancedTherapies

🔍 Confusion between similar drug names is a common source of error and harm in clinical practice – but how can we predict which drug names cause confusion? This studyshows that lab-based psycholinguistic tests of drug name confusion correlate with real-world pharmacy error rates. Findings support using such tests to screen new drug names and improve patient safety. 🔗 https://bit.ly/3IyfxG5