Food and Drug Administration (FDA)
NEWS
Yesterday, the agency and Gottlieb doubled-down on the Action Plan and added to it. The FDA released two new draft Q&A guidance documents on biosimilar development and two final guidance documents on the same topics, as well as a proposed amendment to the definition of a biological product.
It seems like every time we turned around this year, there was an exciting or—on a more visceral level, “Hey, that’s cool!” science story. Here’s a look at the top 9 really cool life science discoveries of the year, from outer space, to peanut allergies, to tortoise genomes.
The U.S. Food and Drug Administration (FDA) has issued an approval letter for the new features and intended uses of the Planmed Verity® CBCT scanner. Planmed is very pleased to bring these exciting improvements to the U.S. market.
Although a moderate presence in Europe, with about 25 biosimilars approved and on the market, they haven’t gained traction in the U.S. Even though at least 11 have been approved in the U.S., only about three are available, largely because of business tactics branded drug companies are using to slow down the competition to their typically very high-priced biologic drugs.
The U.S. Food and Drug Administration (FDA) released a new 2019 strategic Framework for how it plans to advance the use of so-called real-world data (RWD) to improve regulatory decisions. The agency has indicated that this is a strategic priority.
Late Thursday, Genentech said the U.S. Food and Drug Administration granted regulatory approval for a combination of Tecentriq and Avastin for treatment of some metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
The U.S. public apparently believes that drug prices are too high. At the same time, they seem largely opposed to government efforts to control health care costs, alternately supportive and non-supportive of efforts to eliminate the Affordable Care Act, better known as Obamacare.
The FDA is often publishing draft guidelines and asking for expert feedback on that guidance. It’s been a busy week in this regard, with several areas of healthcare and drug development and manufacturing being covered by the agency. Here’s a look.
“Humira is an anti-TNF monoclonal antibody that currently treats Crohn’s disease, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa, psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and uveitis,” quotes Humira developer AbbVie’s website. Those, plus other unlisted ailments, total at 15 conditions treated by only one drug.
JOBS
IN THE PRESS