January 2016

In a comprehensive study of more than 1.3 million people in northern California that stretched over 10 years, researchers have found that blacks, Latinos and Asians had lower risk of coronary heart disease compared to whites.

Nearly 10 percent of British primary care patients who were prescribed anti-depressants for depression or anxiety are having undiagnosed bipolar disorder, reveals a study.

In a first, a team of researchers has successfully replaced both Y chromosomes in mice by increasing expression of just two genes while preserving the male's ability to produce offspring.

Using painkillers in pregnancy may reduce fertility in subsequent generations, warns a research.

Neos Therapeutics, Inc., a pharmaceutical company with a late?stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older.

Biofrontera , the biopharmaceutical company focusing on sun-induced skin cancer, announced recent progress on the ongoing approval process for Ameluz® and BF-RhodoLED® in the USA. FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.

Aortica Corporation  announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study sponsored by Dr. Benjamin Starnes – Chief of Vascular Surgery at the University of Washington (UW).  The supplement names Aortica as the supplier of both a Fenestration Alignment Software and a patient-specific 3-D printed fenestration template.

Boehringer Ingelheim announced the results of the LUX-Lung 7 trial. Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib, versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). The Phase IIb trial met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start, and discontinuation of treatment for any reason).