Food and Drug Administration (FDA)
NEWS
You know when an analyst starts an article with, “Gilead’s Q1 financial results were a disaster,” that it requires a closer look.
Europe began approving biosimilars in 2006. The U.S. has lagged behind, only starting to approve these copycat drugs in 2015. However, of the nine biosimilars approved in the U.S., only three are actually on the market because of barriers thrown up by the biopharma industry.
As Boston-based Rhythm Pharmaceuticals moves its lead obesity treatment into a second Phase III trial, the company was bolstered by the publication of longer-term data from its Phase II study of setmelanotide in Nature Medicine.
Gilead Sciences is facing another round of lawsuits regarding its HIV treatments. This morning the AIDS Healthcare Foundation announced two sets of California-based patients filed a personal injury lawsuit against the Bay Area company regarding safety concerns surrounding its TDF treatment.
Shares of Utah-based Lipocine, Inc. are down more than 41 percent in premarket trading after the company announced it received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its testosterone replacement therapy product.
Akili Interactive, headquartered in Boston, closed a $55 million Series C financing. Akili is a prescription digital medicine company. Its goal is to treat certain disorders via high-quality video games.
The uses of viruses as therapeutics is growing, largely because new gene therapy treatments require viruses.
The stock market has been volatile so far this year, and biotech stocks are right there in the middle of things. Still, there are a few stocks that have taken a beating but will probably recover, and others that appear to be on their way up with every indication of continuing.
Alnylam Pharmceuticals reported preclinical results that supports advancement of its RNA interference (RNAi) therapeutics for central nervous system disorders into the clinic.
JOBS
IN THE PRESS