If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.

HONG KONG – South Korea’s securities exchange operator, Korea Exchange Inc., has relaxed the procedure for tech companies, including biopharma firms, to list on its KOSDAQ board. Under the simplified listing standard, which came into effect on April 26, companies with a market capitalization of ₩500 billion (US$449.26 million) and above will now need to submit only one assessment, with a result of “A” or higher, from a professional evaluation agency.

BioWorld looks at translational medicine, including: Neurons forget who they are in Alzheimer’s disease; Sensor can predict hallucinogenic serotonin receptor effects.

Biovie Inc. Chairman Terren Peizer said Neurmedix Inc. “had been offered a better deal in the shorter term,” but the contract signed by the two firms – which installs entrepreneur Cuong Do the new CEO of Biovie, replacing Peizer – made more sense to both parties. Santa Monica, Calif.-based Biovie is taking over the assets of Neurmedix Inc., of San Diego, bringing aboard phase III-ready NE-3107, an oral small-molecule therapy designed to inhibit insulin resistance in Alzheimer’s disease (AD).