How to Boost Trust in Tech? 4 Perspectives from SXSW
Here are four perspectives from providers, patients, life science executives and healthcare technologists about ways to boost trust at a time of rapid AI deployments.
Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug
Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a "lack of substantial evidence" that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab's commercialization.
The New Blueprint: How Clever Care Health Plan is Scaling Its Member Experience [Video]
MedCity News was at the Vive conference and spoke with executives who shared their insights for the healthcare industry.
Which FDA Division Has the Most Stability As AI Tools Get Adopted Across the Agency?
At SXSW, two FDA observers said stability is returning to the agency after painful DOGE personnel cuts last year, though it's not equal across divisions. And now, AI tools are being adopted across the board to improve efficiency.
Real-World Evidence Meets Machine Learning: What It Takes to Future-Proof Evidence Generation
Every life sciences organization needs to consider how best to apply machine learning (ML) to RWE to support better patient outcomes. Here’s how they can ensure RWE is “ML-ready.”
FDA Drug Approval Marks a First for a Disease — But It’s Not Autism
Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.
The Lethal Cost of Regulatory Perfection in Rare Disease
Congress has already granted the FDA flexibility in evaluating therapies for rare diseases, including the use of real-world evidence and natural history data when traditional large-scale trials are not feasible. The question before the FDA now is not if those tools can be applied – they can – but if the agency has the courage to use them before more patients lose their autonomy, and ultimately, their lives, to rare disease.
The Hidden Administrative Tasks Draining Small Practices
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
Rethinking Where Patient Recruitment Begins
The patients are there. Our recruitment models just aren’t reaching them. Digital patient recruitment is proving to be not just an alternative, but an even more effective approach.
Startup Waiv Spins Out of Owkin With $33M to Bring AI Precision to Cancer Decisions
Waiv, formerly the diagnostics division of AI biotech Owkin, developed AI-enabled testing technologies that found use in clinical settings and in cancer drug research. Spinning out as an independent company enables Waiv to pursue its own growth strategy, co-founder and CEO Meriem Sefta said.
‘They Need Each Other’: Why Hims & Hers and Novo Nordisk Made Up
Novo Nordisk dropped its lawsuit against Hims & Hers and launched a new collaboration. The deal is advantageous for both companies, experts say.
FDA Transparency Push Expands to Monitoring Safety of Vaccines and Other Regulated Products
The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of events cannot be determined.
How Artera is Using Agentic AI to Humanize Patient Care
Artera President Tom McIntyre talks about the practical application of AI in healthcare.
An AI Driven Approach to Address the Non-Responder Gap in Radiopharmaceutical Therapy
The non-responder gap matters for two reasons: First, patients who are in an advanced stage of cancer lose valuable time in ineffective therapy. Second, it increases the cost of therapy and resources for both patients and the broader healthcare ecosystem.
Vertex Pharma to Seek Speedy FDA Approval for Kidney Disease Drug From $4.9B Acquisition
Povetacicept, a Vertex Pharmaceuticals immunology drug designed to block two targets, met the main goal of a Phase 3 clinical trial in the rare kidney disease immunoglobulin A nephropathy. The fusion protein came from Vertex’s acquisition of Alpine Immune Sciences, and analysts say the drug has best-in-class potential.
In the Absence of Objective Measures for ALS, Caregivers are the Only Witnesses. We Shouldn’t Have To Be.
The way we measure ALS progression is failing patients. We are entering a new era of ALS therapeutics but still relying on the same blunt instruments of measurement.
Verily & Samsung Team Up to Bring Smartwatch Data into Clinical Trials
Verily and Samsung are partnering to integrate data from Galaxy smartwatches into Verily’s Pre platform. The goal is to create an end-to-end system that pharma researchers can use to deploy wearable devices in studies, analyze patient data remotely and then interpret the results.
Roche, Zealand Pharma Obesity Drug Meets Clinical Trial’s Weight Loss Goals, But Can It Compete?
Petrelintide posted Phase 2 results showing tolerability comparable to a placebo, but average weight loss that was less than what analysts expected. The Zealand Pharma drug, in development under a partnership with Roche, is a peptide engineered to activate the amylin receptor.