HONG KONG – South Korea's 3billion Inc., a rare genetic diseases diagnosis startup based in Seoul, has secured ?11.4 billion (US$9.6 million) in a series B investment. The company was founded in 2016 as a spinoff of Macrogen Inc., a Seoul-based genetic sequencing biotech, and raised ?3 billion in a series A funding last year. Read More
Polarityte Inc., of Salt Lake City, reported positive results from a pilot study of its Skinte regenerative skin product in the closure of venous stasis leg ulcers (VLUs) after standard treatments have failed. The findings were reported at the Symposium on Advanced Wound Care fall meeting, Oct. 12-14, in Las Vegas. Read More
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining quick U.S. FDA approval based on the early results. Read More
LONDON – A paper that raised concerns for the future health of Lulu and Nana, the world's first gene-edited babies, has been fully retracted at the request of the authors, after they failed to identify a problem in data from the U.K. Biobank on which their analysis was based. The study published in Nature Medicine in June, concluded the edits the twin girls are purported to have in their CCR5 chemokine receptor gene is associated with a 21% increase in mortality in middle and old age. Read More
Canon Medical Systems Corp., of Otawara, Japan, reported the opening of its Middle East Division in Canon Middle East Dubai, United Arab Emirates. Preparations are underway to start business operations around the beginning of January 2020. Madison, Wis.-based Exact Sciences Corp. said that in collaboration with Mayo Clinic, it has initiated the Voyage study to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence and mortality rates. Voyage is a prospective, observational study designed to enroll more than 150,000 people with a valid Cologuard order and follow them for at least seven years to evaluate clinical outcomes. Read More
The U.S. FDA has posted its guidance agenda for this still-young fiscal year (FY), a list that covers topics such as Clinical Laboratory Improvements Amendments (CLIA) waivers. However, the agency appears to be concerned about a lack of compliance with Section 522 postmarket surveillance studies, as indicated by the inclusion of the related guidance in the high priority list for do-overs in fiscal 2020. Read More
