pSivida (NSDQ:PSDV) released its fiscal year earnings for 2015 yesterday and said it’s eyeing an entrance into the orthopedic knee market with a new drug-device implant. The company said it is slated to submit an investigational new drug application with the FDA and begin a study of a new implant using its Durasert technology to […]
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QT Vascular wins CE Mark for drug-coated balloon
QT Vascular said Monday it won CE Mark approval in the European Union for its Chocolate Touch drug-coated balloon for treating vascular disease. The device is a paclitaxel coated balloon meant to treat occluded arteries and mechanically dilate them with a balloon catheter, the company said. Singapore-based medical company said it expects a commercial launch of […]
SteadyMed still steady on Q2
SteadyMed Therapeutics (NASDAQ:STDY) yesterday released quarterly earnings that missed expectations and reported growing losses, but shares stayed steady. SteadyMed is a developer of hypertension and pain treatments given with a discrete, patented drug-delivery device called the PatchPump. The company is focusing on development and approval of Treyvant, a drug to treat pulmonary arterial hypertension. SteadyMed reported losses of […]
Delcath to settle shareholder suits for $8.5m
Delcath (NSDQ:DCTH) said yesterday that it agreed to pay $8.5 million to settle a clutch of lawsuits filed by shareholders over losses related to its development of the drug-device combination Melblez kit. The lawsuits, filed by shareholders in 2013, sought compensation for losses between April 21, 2010, and May 2, 2013, stemming from 3 separate incidents the plaintiffs claim caused […]
Teva Pharmaceutical and Microchips Biotech ink $35m deal for drug-device combo
Teva Pharmaceutical (NYSE:TEVA) and Microchips Biotech said they inked a $35 million co-development deal to explore using Microchips’ implantable drug delivery device with Teva’s line of drugs. The wireless Microchips device can store 100s of doses for months or even years and be programmed to release the drug at precise times or schedules, the companies said yesterday. “The […]
Intersect ENT PO goes over-allotment, closes at $103m
Intersect ENT (NSDQ:XENT) said Tuesday it closed its public offering of 4.1 million shares of common stock at $25 per share. J.P. Morgan and BofA Merrill Lynch were book-runners for the offering, with Leerink Partners, Canaccord Genuity and William Blair as co-managers, the company said.. The deal included 537,300 shares sold through an underwriters option to purchase […]
pSivida and TechniScan drum up $10 million in private rounds
pSivida Corp. (NSDQ:PSDV) and TechniScan Inc. (OTC:TSNI) evidently wanted some privacy in their latest efforts to raise cash.
Watertown, Mass.-based pSivida, which develops ophthalmic drug-delivery devices, expects to net $9.9 million from an equity and warrant-based round involving a group of private investors, the company said today.
Surmodics accomodates Ramius with two new board members
SurModics Inc. (NSDQ:SRDX) named two board members put forth by its largest shareholder, New York-based investment firm Ramius LLC.
The Eden Prairie, Minn.-based company said it named Ramius managing director Jeffrey Smith and Wheatley Partners partner Dr. David Dantzker to the board effective immediately.
FDA rejects Iluvien, pSivida-Alimera's drug-device eye treatment
pSivida Corp. (NSDQ:PSDV) partner Alimera Sciences Inc. (NSDQ:ALIM) received a rejection letter from the Food & Drug Administration for their drug-device combination Iluvien.
The two companies are developing the system to treat diabetic macular degeneration. The investigational drug delivery system is designed for sustained release of Iluvien with an intra-vitreal insert.
Pulmatrix lands $5.7 million grant from Uncle Sam
Pulmatrix Inc. landed a $5.7 million contract from the Defense Advanced Research Projects Agency to develop a drug/device combination aimed at protecting military personnel and civilians against biological weapons.
DARPA selected the Lexington, Mass.-based company as part of its “7-day Biodefense Initiative,” a project to develop inhaled therapeutics for respiratory infections caused by airborne agents.