August 2015

Symbiomix completes SYM-1219 enrollment

Monday, August 31, 2015

Symbiomix has completed patient enrollment in a phase III clinical study, the second pivotal trial of SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish the second pivotal trial by the end of 2015, which would enable an NDA filing with the FDA in mid-2016.

[Read More]

tranSMART platform named award finalist

Monday, August 31, 2015

The tranSMART Foundation, a nonprofit organization providing a global, open-source knowledge management platform for scientists to share pre-competitive translational research data, has announced its tranSMART v1.2 platform has been selected as a 2015 R&D 100 Award Finalist by R&D Magazine in the Software/Services category. The R&D 100 Award recognizes the 100 most technologically significant products introduced in the past year.

[Read More]

FDA approves Repatha injection

Monday, August 31, 2015

Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

[Read More]

NIH launches human RSV study

Monday, August 31, 2015

A new study will expose healthy adult volunteers to respiratory syncytial virus (RSV), a virus that causes cold-like symptoms in adults. Better understanding of how adults develop RSV infection and immune system responses to infection will assist researchers in developing and testing future antivirals and vaccines to combat the virus. The research is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

[Read More]

Halozyme taps Labarre as chief scientific officer

Monday, August 31, 2015

Halozyme Therapeutics, a San Diego-based biotechnology company developing novel oncology and drug-delivery therapies, has named Michael J. LaBarre, Ph.D., as chief scientific officer, succeeding Dr. Michael Shepard, who was appointed a Research Fellow for the company. The move broadens LaBarre’s responsibilities to include R&D of early pipeline assets, in addition to his role managing product development and ENHANZE platform partnerships.

[Read More]