Although the stock is down likely due to the company pushing out its Phase 1/2 cohort 3 update for DTX301 to Q4, potentially enrolling a more diverse patients group for its Phase 1/2 dose confirmation study for DTX401 and uncertainty on Phase 3 endpoints for DTX401, Schwartz remains positive on DTX401 as he believes that Ultragenyx could continue to deliver clinical benefit for patients.
24, 2018 (HealthDay News) -- There is variation in the net clinical benefit of anticoagulants based on variation in published atrial fibrillation (AF) stroke rates, according to a study published online Sept.
The product was approved using the Accelerated Approval pathway, under which the US FDA is likely to approve drugs for serious conditions where there is an unmet medical need and where a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients.
"As per current guidelines, when tolerated, statins should be the first-line therapy given the large reductions observed for LDL-C [LDL cholesterol], the excellent safety profile, the demonstrated clinical benefit, and low cost (now that most are generic).
In its first year, the Medicare Pioneer accountable care organization (ACO) program resulted in modest reductions in low-value medical services that provide minimal clinical benefit to patients, according to a study published in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2015.4525).
In contrast, VBID plans reduce the cost to the patient for medications that offer higher clinical benefit, with the intent that increased medication use improves health outcomes and reduces overall health care spending.
Two four-week Phase IIa clinical studies already demonstrated GLPG0634's favourable safety profile and clinical benefit to RA patients, while supporting the selection of doses for the current trial, Galapagos said.
A recent clinical trial found that interferonI2-1a (INF) and glatiramer acetate (GA), two of the most commonly prescribed drugs for multiple sclerosis (MS), provide no additional clinical benefit when taken together.