Delcath (NSDQ:DCTH) said today it launched a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma. The newly initiated Focus trial will examine the safety, efficacy and pharmocokinetic profile of its Melphalan and HDS system when compared with the standard of care, the New […]
Business/Financial News
Clearside Biomedical raises $14.4m, enrolls 1st patient in Phase III trial
Clearside Biomedical raised $14.4 million in a new round of equity financing, and said yesterday it enrolled the 1st patient in the Phase 3 Peachtree clinical trial of its CLS-TA for treating patients with macular edema associated with non-infectious uveitis. Clearside is developing CLS-TA triamcinolone acetonide to be delivered using its proprietary SCS microinjector for patients with […]
Intersect ENT touts economic data from from Propel study
Intersect ENT (NSDQ:XENT) said today that budget impact data on its Propel steroid releasing implant for treating chronic sinusitis showed upfront costs offset by savings post-operatively. The data was presented at the International Society for Pharmaeconomics and Outcomes Research annual meeting in Milan, Italy. “A previous study demonstrated the use of Propel in sinus surgery […]
Unilife amends Novartis supply deal
Unilife (NSDQ:UNIS) said today it amended a clinical supply agreement with Novartis (NYSE:NVS) to supply it with additional batches of Unilife’s drug delivery device for use with a novel investigational drug. The agreement, originally signed in 2013 to supply them with the deliver devices for a targeted early-stage pipeline drug, was also amended to include an […]
pSividia eyes knee market, releases earnings
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 […]
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 […]
