June 2016

In a small study looking at pain assessments in adults with sickle cell disease, researchers at Johns Hopkins says overall, those treated long-term with opioids often fared worse in measures of pain, fatigue and curtailed daily activities than those not on long-term opioids.

Most clinical research is not useful to clinicians. This could change.Many billions of dollars are spent on clinical research every year, yet much of the knowledge produced is not useful for guiding clinical decision making. Because many of the features that make clinical research reliable as a basis for clinical practice can be identified, more useful clinical research could easily be produced at the same or even at massively reduced cost, according to John Ioannidis from Stanford University, US, in an Essay published in PLOS Medicine.

SORLA is a protein that influences the balance of metabolic processes in adipose tissue, a particular form of fat. Too much of it makes fat cells overly sensitive to insulin, which leads them to break down less fat. SORLA was previously known for its protective role in Alzheimer's disease.

Researchers at Joslin Diabetes Center have announced the results of a study that may change how nutrition therapy is delivered to overweight and obese patients with type 2 diabetes. The "Nutrition Pathway Study" compared three models of nutrition therapy and found that a highly structured nutrition plan provides the most significant impact on A1C, body weight and lipid profiles. The study results were presented at the American Diabetes Association's 76th Scientific Sessions in New Orleans, Louisiana.

Collegium Pharmaceutical, Inc. announced the commercial launch of Xtampza ER (oxycodone) extended-release (ER) capsules in the United States. Xtampza ER was approved by the US Food and Drug Administration (FDA) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Perrigo Company plc announced it has received final U.S. Food and Drug Administration clearance for three milk-based, store brand non-GMO infant formulas.  Shipments to retail customers have already commenced.

WAVE Life Sciences Ltd. announced that its lead candidate WVE-120101, which is being investigated for the treatment of Huntington’s disease (HD), has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). WVE-120101 targets rs362307, a Single Nucleotide Polymorphism (SNP) that is associated with the disease-causing mutation in the huntingtin (HTT) gene. WAVE’s approach enables selective silencing of the disease-causing HTT allele, while leaving the healthy HTT allele to produce normally functioning protein.

Fate Therapeutics, Inc. announced  that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ProTmune™ for the reduction of incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). In addition, the Company announced that its multi-center, randomized, controlled Phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies is open for patient enrollment.