Archives May 2019

Update On FDA’s Comprehensive Regenerative Medicine Policies And Enforcement Activities

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by obtaining investigational new drug applications (INDs) and working towards premarket approval of their products. Recent public statements by FDA officials reiterating

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Athersys Announces Fast Track Designation From FDA for MultiStem® Program for Acute Respiratory Distress Syndrome

Athersys, Inc. (Nasdaq: ATHX) announced today that its clinical program evaluating MultiStem® cell therapy for the treatment of Acute Respiratory Distress Syndrome (“ARDS”) has received Fast Track designation from the United States Food and Drug Administration (“FDA”). This important designation is given to qualified investigational therapies that show promise in providing benefit to patients in

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In a controlled Trial for Mild Asthma Budesonide–Formoterol as needed found superior to Albuterol

In double-blind, placebo-controlled trials, budesonide–formoterol used on an as needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β2 -agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical

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RESTORE Large Scale Research Initiative Kick-off Meeting in Berlin

Last week, RESTORE held its Kick-off Meeting in Berlin. Maxing out the capacity of the venue, 200 representatives of supporters and partners came together for discussions, presentations and networking. We are humbled by the engagement and spirit of all involved in speaking, drawing and discussing over two packed days and making this event a success! At the

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Distinguishing different subtypes of sepsis by machine learning sets the stage for individualized treatment, researchers say

Four clinical sepsis phenotypes were identified that correlated with host-response patterns and clinical outcomes, researchers reported here. The four novel sepsis phenotypes — alpha (α), beta (β), gamma (γ), and delta (δ) — with different demographics, laboratory values, and patterns of organ dysfunction were derived, validated, and shown to correlate with biomarkers and mortality, according

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AI can predict patient response to popular Crohn’s treatment

A predictive machine learning model was able to identify how effectively patients with Crohn’s disease would respond to long-term usage of ustekinumab, according to a new study in JAMA Network Open. Researchers from the University of Michigan trained the model using demographic and laboratory data obtained in previous clinical trials. The data described 401 patients with active Crohn’s

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