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The explosion of compounded GLP-1 offerings over the past two years is coming to an end, and many patients are left with no good options. Businesses are changing prescriptions, mixing in additives, or encouraging stockpiling of existing compounded products. Some have disappeared altogether.
That could include anything from modeling to cut down on animal-based toxicology studies to developing AI-based clinical trial endpoints to evaluating adverse events after the FDA approves a drug. Most of the compounds came from commonly prescribed medications including antidepressants and statins.
The insurance complications have led many users to try compounded versions, or pay out of pocket for vial doses from Lilly and Novo through their direct-to-patient platforms. Launches DSai™ — AI-Powered Digital Sign-In to Modernize HCP Event Compliance in L… From Groupize.ai The jurys still out on whats going to happen,” Faycurry said.
AI models can predict molecular interactions and assist in designing novel compounds tailored to specific therapeutic goals. AI-driven screening methods, such as High-Throughput Screening (HTS), allow researchers to rapidly evaluate large libraries of compounds.
Purple Life Sciences, a company focused on harnessing natural ingredients for medical treatment, launched PSOCARE, a healing oil for psoriasis, at an event today. These products will blend natural compounds with advanced formulation technologies to provide natural, side-effect-free alternatives to conventional treatment methods.
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Treatment-related adverse events (AEs) included nausea (77.8% vs 10.8%, respectively), and major bleeding events (2.4% 5 Primary end points included safety, with secondary end points of overall response rate (ORR), progression-free survival (PFS), and duration of response. ORRs were 94.4% in the TN cohort (95% CI, 72.7%-99.9%)
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Nacher : I think, as I said, rusfertide being a first-in-class hepcidin mimetic is huge—especially for patients with [PV]—to hopefully reduce the phlebotomy burden and prevent some of the sequelae of the disease, including cardiovascular and thrombotic events.
2 More recent changes in many states include the ability to prescribe oral contraceptives and plan outreach events to monitor blood pressure or cholesterol; the latter, when coupled with referral to appropriate medical services, is a valuable intervention. 2 The pharmacy profession needs to improve in 2 areas.
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Despite its proven efficacy, the conventional oral administration of lenalidomide presents challenges due to its short half-life and the high systemic exposure required to sustain therapeutic drug levels, which can lead to significant toxicities, particularly grade 3 or 4 hematologic adverse events (AEs).
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Related Content Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia Patrick Lavery June 9th 2025 Article The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
By meticulously reviewing medication regimens, reconciling discrepancies, and providing comprehensive education to patients and caregivers, they significantly reduce the likelihood of medication errors and adverse drug events during these vulnerable periods.
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The regimen maintained stem cell collection feasibility with no new safety concerns, despite some adverse events like neutropenia and infections. Five patients died during this time, with causes including disease progression (n = 1), cardiac events (n = 2), and other unrelated causes (n = 2).
Adverse events were common but comparable between dupilumab and placebo, with no deaths in the dupilumab group. 3 Overall rates of adverse events (AEs) were 96% (n = 51) in the dupilumab arm and 96% (n = 51) in the placebo.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.
REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. 2 Critically, a REMS designation does not automatically translate to universal mitigation of adverse events associated with a medication. Only some medications—including CAR T therapies—carry REMS designations.
Pharmacy Times: What role do you see pharmacists playing in the discussions and advancements presented at the event? There are going to be a lot of key takeaways that will be important for the pharmacist to know. Isaacs: It's great if pharmacists can be there, but even if not, there's a virtual option as well.
Establish revalidation triggers based on risk events such as new equipment, layout changes, or shifts in personnel competency. The case led to criminal convictions and lasting changes in compounding pharmacy regulations. Define clear lifecycle plans for process validation, visual inspection qualification, and CCI.
Among the 37 practices that reported waste, 768 events were reported, leading to a total drug waste of $11,275,642.16. These events foster innovation, collaboration, and professional growth within the oncology pharmacy community. compared with $546,082.45 for the external mail-order pharmacies. Of that, $8,935,612.15
The primary end point was mean change in home systolic BP (SBP) from baseline to week 12, and the primary safety outcome was treatment discontinuation due to an adverse event (AE) from baseline to week 12, with secondary end points including differences in clinic and home blood pressure levels and control rates.
Participants experienced no severe hypoglycemic events, and glycated hemoglobin levels remained below 7%. Most adverse events were mild or moderate, with no serious events linked to zimislecel. The FORWARD trial's phase 3 aims to evaluate zimislecel's safety and efficacy over five years.
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A comprehensive review of 90 studies involving more than 14,000 patients demonstrated no increase in adverse events, immunogenicity, or loss of clinical effectiveness following a switch. Scientific evidence does not support the belief that switching from a reference biologic to a biosimilar compromises safety or efficacy.
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Adverse events include infusion reactions, nephrotoxicity, and ototoxicity, with pediatric patients potentially experiencing more severe reactions. The ready-to-infuse formulation simplifies administration, reducing preparation steps and enhancing treatment efficiency in healthcare settings.
Cytokine release syndrome was the most common adverse event, occurring in 80% of patients, with 3% experiencing grade 3 or higher. 4 The safety profile showed cytokine release syndrome (CRS) as the most common adverse event (AE) in 80% of patients, of which 3% experienced grade 3 or higher CRS. 4 At the median follow-up of 11.6
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3 All 100 patients also displayed a favorable safety profile with 85% mild to moderate adverse events and 4 device- or procedure-related serious adverse events, including abdominal pain, radioembolization-induced liver disease, and nausea. Additionally, all evaluable patients demonstrated a 100% local tumor control rate.
Despite high adverse event rates, dupilumab had no treatment-related deaths, unlike the placebo group, which had two. 3 Overall rates of adverse events (AEs) were 96% (n = 51) in the dupilumab arm and 96% (n = 51) in the placebo.
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SHOW MORE Oral semaglutide shows promising cardiovascular benefits for type 2 diabetes patients, reducing major adverse events by 14% in the SOUL trial. Secondary outcomes included major kidney disease events based on a 5-point composite, as well as major adverse limb events.
Dave Randolph | Image courtesy of McKesson The highlight of this year’s event was the announcement of Dave’s Pharmacy in Alliance, Nebraska, as the winner of the Pharmacy of the Year Award, recognizing the pharmacy’s outstanding contributions to patient care and community health.
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