Source: TMF The next telecommunication revolution is just around the corner: the promises of high bandwidth, low latency and low-power-low-cost of 5G will open the gate to a flood of new inventions and the implementation of ideas, which have already been for long in the public consciousness – such as stable augmented reality or truly
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
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
Source: Reuters Novartis AG is offering price discounts in negotiations with U.S. health insurers on its gene therapy for spinal muscular atrophy (SMA), a treatment that could cost more than a million dollars, but the gesture comes with strings attached. The Swiss drugmaker wants insurers to commit to coverage for patients identified with the rare
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
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
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
As a physician trying to keep up with all the new information about artificial intelligence, I want to know how machine learning and deep learning are impacting medicine now and to separate the hype from reality. Here’s a look at some ways AI is being used successfully in health care and some ways it is
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
By the time they reach school age, about 90 percent of children will have experienced a condition in which fluid fills the middle ear, muffling sound and sometimes triggering infection. Diagnosis usually requires a visit to a specialist—but researchers have now developed an app that detects this fluid just as accurately, with only a smartphone
