Policymakers Must Balance Innovation With Patient Safety for AI in Healthcare
When it comes to artificial intelligence (AI) in healthcare, policymakers must balance innovation with potential harms to patients and healthcare workers, lawmakers and witnesses said during a Senate hearing Wednesday. “I have concerns because when we talk about the promises of AI, we need to also talk about its risks,” chair Edward Markey (D-Mass.) said […]
To Get More New Antimicrobial Drugs, Fix the Broken Market, Experts Say
Fixing the broken market for innovative antimicrobial drugs should start with the hospitals, said Christine Ann Miller, MBA, at the Future of Health Summit sponsored by the Milken Institute on Tuesday. Because hospitals under the diagnosis-related group (DRG) system get paid a lump sum for treating a patient with a particular disease or condition, “hospitals […]
Sparsentan Bests Irbesartan for Preserving Kidney Function in IgA Nephropathy
PHILADELPHIA — Sparsentan (Filspari) outperformed irbesartan in patients with IgA nephropathy over the 2-year phase III PROTECT trial. Over a 110-week treatment period, those on sparsentan had an average 42.8% (95% CI -49.8 to -35.0) reduction in urine protein-to-creatinine ratio compared with a 4.4% (95% CI −15.8 to 8.7%) reduction with irbesartan (geometric least-squares mean […]
Maintenance Selinexor May Boost PFS in TP53 Wild-Type Advanced Endometrial Cancer
SEOUL, South Korea — Maintenance therapy with selinexor (Xpovio) seemed to substantially extend progression-free survival (PFS) in patients with wild-type TP53 advanced or recurrent endometrial cancer, according to data from the SIENDO trial. The updated, long-term data from the phase III study showed that, at a median follow-up of 25.3 months, median PFS was 27.4 […]
Efgartigimod Offers Hope in Chronic Inflammatory Demyelinating Polyneuropathy
PHOENIX — A subcutaneous infusion of efgartigimod cut the risk of relapse in patients with a rare but serious immune-mediated neuropathy, according to the phase II ADHERE trial. Patients with diagnosed chronic inflammatory demyelinating polyneuropathy (CIDP) treated with efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) saw a 61% reduction in the risk of relapse versus placebo, […]
Regulation Gap Persists in OTC Eye Care Products
It’s been a bad year for over-the counter (OTC) eye care products and their consumers, with serial government warnings and company recalls of ocular washes, drops, tears, and ointment. And the current state of the OTC industry has U.S. ophthalmologists worried on two fronts, according to a viewpoint overview in JAMA Ophthalmology. “On one side, […]
Rozanolixizumab Maintains Efficacy Among Generalized Myasthenia Gravis Subgroups
PHOENIX – Across subgroups, patients who had their generalized myasthenia gravis (gMG) treated with rozanolixizumab (Rystiggo) maintained their responses through multiples cycles of treatment, based on extension data from the phase III MycarinG clinical trial. Those with anti-acetylcholine receptor (AChR)-positive gMG receiving the higher dose of rozanolixizumab saw average Myasthenia Gravis-Activities of Daily Living (MG-ADL) […]
Adding Atezolizumab Improves Survival in Advanced Cervical Cancer
First-line treatment with the anti-PD-L1 inhibitor atezolizumab (Tecentriq) combined with bevacizumab (Avastin) and platinum-based chemotherapy significantly improved survival in patients with metastatic or recurrent cervical cancer, according to results of the phase III BEATcc trial. The median progression-free survival (PFS) was 13.7 months with added atezolizumab compared with 10.4 months with the standard bevacizumab plus […]
Thalidomide Reduced Episodes of Recurrent GI Bleeding
Treatment with thalidomide led to a reduction in bleeding among patients with recurrent bleeding due to small-intestinal angiodysplasia (SIA), a randomized trial showed. In 150 patients, 68.6% of those who received 100-mg thalidomide daily for 4 months experienced a reduction of 50% or more in bleeding episodes in the year after treatment compared with 51% […]
FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices
The FDA has released revised draft guidance on communicating with healthcare professionals (HCPs) about unapproved uses of approved drugs and devices. Once it’s finalized, the document will reflect FDA’s stance on how companies can communicate scientific information to clinicians regarding unapproved uses of products already on the market. Comments are open through December 24. “In […]