The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.
Biogen (BIIB) today announced new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and safety of SPINRAZA® (nusinersen) among pre-symptomatic infants with spinal muscular atrophy (SMA). In NURTURE, all infants treated with SPINRAZA were alive, did not require permanent ventilation and showed improvement in motor function and motor milestone achievements as of July 5, 2017, compared to the disease’s natural history. This study, along with a case series demonstrating SPINRAZA’s effectiveness among teens and young adults, will be presented at the Muscular Dystrophy Association (MDA) Clinical Conference on March 11-14, 2018, in Arlington, Virginia.
Janssen leads in cardiovascular innovation using real-world data to detect asymptomatic atrial fibrillation Home-based clinical study underscores the game-changing role of digital technology in future of health care
An organ-on-a-chip model of the human gut could offer a better prediction of the effect of radiation exposure on humans than animal testing.
As Pfizer clears house of its unwanted neuro assets, Biogen has become a buyer for one, namely a phase 2-ready schizophrenia drug.
The Menarini Group announced today that on March 6th 2017 it submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix. The proposed indication for delafloxacin in Europe is the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and the conclusion of the European regulatory process is expected in IIQ 2019.
An AliveCor algorithm has identified people with high potassium levels from electrocardiogram (ECG) data. Limited prospective clinical testing suggests pairing the algorithm with AliveCor’s smartphone and Apple Watch-based ECGs could enable the remote, noninvasive monitoring of potassium levels.
HIV infection is associated with a greater risk for abdominal obesity and, perhaps indirectly, a greater risk for elevated LDL cholesterol and hypertriglyceridemia, according to recent findings.
Cedars-Sinai will be testing a digital pain-reduction kit, which includes VR glasses and mHealth wearables, to see if mobile health technology can replace opioids for people recovering from workplace injuries.
Science 37, a trailblazing company focused on “site-less” clinical trials, announced today a strategic alliance with Novartis that will support the development of its new decentralized clinical trial (DCT) offerings. This three-year commitment will enable a more extensive portfolio of trials powered by the Network Oriented Research Assistant (NORA®), Science 37’s proprietary technology platform that enables patients to participate in clinical research regardless of their geographical location using mobile devices and telemedicine services.
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