its experimental drug for the “wet” form of age-related macular degeneration.
—Moderna Therapeutics, the privately held messenger RNA drug developer worth more than $7.5 billion, is preparing for what could be biotech’s biggest-ever IPO as soon as this winter, STAT reports. Xconomy looked at Moderna’s decision to build big before an IPO earlier this year.
—Principia Biopharma (NASDAQ: [[ticker:PRNB]]) raised $106 million in an upsized IPO, selling 6.25 million shares priced at $17 apiece. The South San Francisco, CA, biotech, whose lead drug is ready to advance into late-stage testing for a rare skin disease, initially planned to sell 4.6 million shares in the range of $15 to $17 each.
—Though the strong momentum for biotech IPOs continues, some worry the party is coming to an end, Bloomberg reports.
REGULATORY MOVES
— FDA commissioner Scott Gottlieb said teen use of electronic cigarettes is now “an epidemic proportion of growth.” He ordered developers like Juul Labs to take steps within 60 days to keep e-cigs away from minors or the FDA might take some products off the market or file charges.
—The FDA cleared two apps for the Apple Watch, one that notifies the wearer of an irregular heartbeat, and another that functions like an electrocardiogram. Gottlieb took to Twitter to explain the FDA’s decisions.
THREAD: #FDA’s approval of 2 medical apps for Apple’s iWatch is a significant step forward in FDA policy because we decoupled review of the app from review of the watch itself. The watch isn’t a medical device, just the apps that help consumers detect serious medical conditions pic.twitter.com/Rv2G8GttMk
— Scott Gottlieb, M.D. (@SGottliebFDA) September 13, 2018
—Regulators in Europe approved a Merck (NYSE: [[ticker:MRK]]) combo regimen of the immunotherapy pembrolizumab (Keytruda) and chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer (NSCLC). The FDA approved the drug combination last month.
—Separately, by Jan. 11, the FDA could approve pembrolizumab, on its own, for first-line NSCLC patients with 1 percent or more of the protein PD-L1 on their tumors. Pembrolizumab is currently approved for NSCLC patients whose tumors express much higher levels of PD-L1.
—Fremont, CA-based Ardelyx (NASDAQ: [[ticker:ARDX]]) filed for FDA approval of tenapor, a drug developed to treat irritable bowel syndrome with constipation.
PEOPLE IN THE NEWS
—The Lasker Awards, the biomedical honor sometimes called “America’s Nobels,” were announced this week. Winners were recognized for discoveries in anesthesia, RNA biology advances, championing women in science, and research in gene regulation.
—The New York Times and ProPublica reported that high-profile cancer researcher Jose Baselga, the chief medical officer of Memorial Sloan-Kettering Cancer Center in New York, has repeatedly failed to disclose lucrative ties to drug and diagnostics companies in dozens of papers published in medical journals. Baselga resigned from Sloan Kettering on Thursday.
—Takeda Pharmaceutical, which is in the process of acquiring Shire (NASDAQ: [[ticker:SHPG]]) will close its U.S. headquarters in Deerfield, IL, where it employs about 1,000 workers, and move it to the Boston area. Ireland-based Shire has U.S. headquarters in Lexington, MA, and Takeda Oncology is in Cambridge, MA.
Ben Fidler and Alex Lash contributed to this report.
Image by Dave Winer via a Creative Commons license
