QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a paclitaxel-coated version of the Chocolate balloon that won FDA approval back in June 2014, the Singapore-based company said. “We are delighted with the CE […]
Intarcia, Numab log milestones for autoimmune drug-device combo
Intarcia Therapeutics and pharmaceuticals maker Numab said today that they’ve logged several milestones in their joint project to develop a drug-device combination for treating inflammatory and autoimmune diseases. Wädenswil, Switzerland-based Numab identified a pair of antibody-based compounds for the program, which aims to use the delivery and formulation technology developed by Cambridge, Mass.-based Intarcia. The companies said […]
Clearside Biomedical floats $50m IPO
Clearside Biomedical raised $50 million with its initial public offering, floating 7.2 million shares at $7 apiece. That’s below the range Clearside earlier set for the IPO, when it planned to put up 4.0 million shares at a range of $14 to $16, for a midpoint value of $60 million. Alpharetta, Ga.-based Clearside is developing a drug-device combination to treat […]
FDA approves Biofrontera's drug-device combo for sun-induced skin cancer
Biofrontera (ETR:B8F) shares are up today after the said it won pre-market approval from the FDA for its drug-device combination treatment for a type of sun-induced skin cancer. Leverkusen, Germany-based Biofrontera said the approval covers its Ameluz drug and BF-RhodoLED medical device for what it calls “photodynamic therapy” to treat mild to moderate actinic keratosis of the face […]
Windgap Medical raises $3m for epinephrine auto-injector
Windgap Medical said in a regulatory filing today that it raised a debt-and-options round worth $2.9 million for the epinephrine auto-injector it’s developing. Somerville, Mass.-based Windgap is working on a device that would mix a dry formulation of the drug into solution, then inject it into a patient suffering from anaphylaxis due to an acute […]
SurModics launches 1st-in-human trial for SurVeil drug-coated balloon
SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker. The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The […]
Capsugel said to explore sale, IPO
Capsugel‘s private equity owner is said to be exploring a sale or initial public offering for the Pfizer (NYSE:PFE) spinout. A deal could value Capsugel, which makes hard capsules and drug delivery products, at more than $5 billion, Reuters reported, citing “people familiar with the matter.” Private equity shop KKR & Co. (NYSE:KKR) paid $2.38 billion for Capsugel […]
pSivida surges on Medidur data
Psivida (NSDQ:PSDV) shares surged today after the company said its Medidur drug-device combination met the primary endpoints in a Phase III clinical trial for treating posterior uveitis. Medidur uses the same injectable implant and drug as the Iluvien drug-device combo pSivida licensed to Alimera Sciences (NSDQ:ALIM) for treating diabetic macular degeneration. Iluvien won FDA approval in September […]
Alimera surges on buyout rumors
(Reuters) — Alimera Sciences (NSDQ:ALIM), an ophthalmic pharmaceutical company, is in the early stages of exploring strategic alternatives, including a potential sale, according to people familiar with the matter. The company has reached out to investment banks to seek advice on how it would be valued in a potential sale and who the likely buyers would be, […]
Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which is designed to deliver sustained dosage of dexamethasone over 4 weeks, using a hydrogel plug […]