ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]
FDA OKs Endo's opioid cheek patch licensed from BioDelivery Sciences
(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 […]
FDA rejects AcelRx's request for meeting on pain drug device
FDA seeks additional trial on Zalviso drug-device combo from AcelRx
(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.
Unilife signs production deal with Flextronics
Intersect ENT registers $80M IPO for sinus implants
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.
Delcath Systems tanks following reverse stock split
Corium poised for $66M IPO for wearable drug-delivery devices
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.
Ocular Therapeutix launches Phase III trial for eye plug
Bedford, mass.-based Ocular Therapeutix launched Phase III human clinical studies of its drug-releasing optical plug in patients undergoing cataract surgery.
Avedro application needs more work, FDA says
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.
