Like drugmakers are apt to do, Regeneron Pharmaceuticals Inc. is looking upstream of its current indications to capture additional patients for its anti-VEGF eye drug, Eylea (aflibercept), but not every analyst is convinced an additional indication will result in sustainably increased sales. Read More

Valneva SE, of Lyon, France, reported interim phase I results from Lyme vaccine candidate VLA-15, showing the study met its primary endpoint with a favorable safety profile. Read More

Striving to maintain the Hatch-Waxman balance between innovation and access to affordable prescription drugs, the Massachusetts Supreme Judicial Court closed the door on holding a brand manufacturer responsible for state failure-to-warn claims, due to negligence, stemming from use of a generic product.  Read More

Heron Therapeutics Inc. hit a home run in dual phase III trials examining its non-opioid candidate, HTX-011, to control postoperative pain in patients following bunionectomy and hernia repair. Top-line data showed that HTX-011 achieved its primary and key secondary endpoints, producing statistically significant reductions in both pain intensity and need for opioids through 72 hours post-surgery compared both to placebo and to bupivacaine solution, the current standard of care. Importantly, fewer patients who received HTX-011 reported severe pain at any post-op time point, and more who received HTX-011 were opioid-free through 72 hours past surgery. Read More

LONDON - The first widespread screen assessing the effect of more than 1,100 marketed drugs on the human microbiome shows that 27 percent of those products inhibit the growth of at least one species of bacteria found in the gut. Read More

TOKYO - Following more than a decade of mostly steady progress on Japan's drug regulation and business development fronts, dangers to well-compensated therapeutic innovation are creeping ever-forward in the important Asian market, industry representatives warned. Read More

LONDON - The vision of two people given implants of retinal pigment epithelium (RPE) cells derived from human embryonic stem cells (hESCs) improved over the first year after receiving the patch. Read More

HONG KONG –LG Chem Ltd. recently received marketing approval for Eucept, its etanercept biosimilar, from South Korea's Ministry of Food and Drug Safety. Based on Amgen Inc. and Pfizer Inc.'s blockbuster biologic, Enbrel, the approval for Eucept is significant for LG Chem, marking the first monoclonal antibody it has developed. Read More

SHANGHAI - XW Laboratories Inc.'s lead candidate, a small-molecule drug for narcolepsy, has begun dosing in healthy patients in Australia. Based in Wuhan and Taipei, XW Labs decided to head to Australia for phase I for a variety of reasons, even though moving to first-in-human trials in China has become more viable after CFDA reforms. Read More

Twoxar Inc., of Palo Alto, Calif., an artificial intelligence (AI)-driven company, said it raised $10 million from a series A financing led by Softbank Ventures.  Read More

Cellectar Biosciences Inc., of Madison, Wis., said the FDA's Office of Orphan Products Development granted orphan drug designation to CLR-131, its lead phospholipid drug conjugate (PDC) product candidate, for the treatment of neuroblastoma, a rare pediatric cancer. Read More