The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations. Read More
While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. Read More
Recognizing that the age of artificial intelligence (AI) has arrived and, with it, the potential to transform everything from health care to transportation and manufacturing, U.S. President Donald Trump issued an executive order earlier this year that launched the American AI Initiative. Read More
BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs. Read More
HONG KONG – With an aging population and a shortage of doctors, Japan is now working to develop artificial intelligence (AI)-based medicine faster than any other country in Asia. Read More
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Read More
HONG KONG – South Korea is actively working to expand its artificial intelligence (AI) capabilities in health care, but outdated regulations and concerns over privacy and profit sharing are proving to be significant stumbling blocks. Read More
NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. Read More
EW Healthcare Partners, of New York, said it raised over $745 million in EW Healthcare Partners Fund 2a L.P., its second dedicated growth equity fund. The fund will target fast-growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the U.S. and in Europe. Read More
Snap Bio Inc., of San Diego, along with Biomedical Research of Barcelona, said its lead candidate, SNP-162, overcame disabling drug-resistance in treating recurrent advanced and metastatic liver cancer. SNP-162 is designed to inhibit the growth of liver cancer cell lines that are resistant to Sorafenib, which is FDA-approved for treating inoperable hepatocellular carcinoma. Read More
The U.S. Department of Health and Human Services (HHS) is appealing a federal judge's decision that struck down a rule requiring TV ads for certain prescription drugs to include the list price of the drug. Read More
Kidney-disease player Chinook Therapeutics Inc. CEO Eric Dobmeier told BioWorld that the company's $65 million series A round provides "a few years of money at the current pace. I'm hopeful we're going to make progress, have really good use of proceeds, and be out there raising money again to advance the company, because there's just such a huge unmet need right now." Read More
