The venture firm hopes to create its next success story with the launch of Revolution Medicines, a biotech focused on using its chemical platform to transform natural products into drugs with fewer side effects, but more potent efficacy.
Third Rock is trying to tap into current interest in all-natural products, from paleo diets to alternative medicines, by launching a biotech focused on synthesizing pharmaceutical compounds from complex natural products.
“Natural products are rich with biological information and have survived natural selection pressures,” Revolution Medicines President and CEO Mark Goldsmith...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
