(Reuters) — BioDelivery Sciences International said the FDA approved its opioid cheek patch for chronic pain, sending the drugmaker’s shares up 23% in premarket trading today. Endo International (NSDQ:ENDP) licensed the worldwide manufacturing and marketing rights to the treatment, Belbuca, from BioDelivery in 2012. Belbuca is an opioid film patch and aims to treat patients with […]
(Reuters) — AcelRx Pharmaceuticals (NSDQ:ACRX) said the FDA wants an additional study on its Zalviso drug-device combination, which the safety watchdog already rejected once last year.
Drug-eluting devices maker Intersect ENT hopes to raise as much as $80 million in a newly registered initial public offering, according to SEC documents filed this week.
Drug-delivery devices maker Corium could raise up to $66 million through an initial public offering, the company announced in SEC filings today.
Corium plans to offer 5.5 million shares of common stock for $10-$12 apiece, putting its total offering value at between $55-$66 million. At the middle rate of $11 per share, Corium expects its net proceeds to amount to $53.7 million after expenses.
Bedford, mass.-based Ocular Therapeutix launched Phase III human clinical studies of its drug-releasing optical plug in patients undergoing cataract surgery.
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.