Keystone Nano said today that its ceramide nanoliposome won orphan drug status from the FDA for the treatment of liver cancer. The designation provides the company with a window of market exclusivity after product approval. The State College, Penn.-based company touted its nanoliposome delivery system as being able to load both water-loving and water-hating compounds and […]
SteadyMed details commercialization plans for Trevyent
SteadyMed Therapeutics (NSDQ:STDY) today detailed the development of its lead drug candidate, Trevyent (treprostinil sodium), for the treatment of pulmonary arterial hypertension using its PatchPump tech at the Parenteral Drug Assn. Conference in Huntington Beach, Calif. PatchPump is the 1st single-use, wearable, pre-filled pump and treprostinil will be the 1st drug integrated with the delivery system, according to the San […]
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
Mast Therapeutics inks deal with Philips Respironics for iNeb aerosol delivery device
Mast Therapeutics (NYSE:MSTX) said today that its subsidiary Aires Pharmaceuticals landed a collaborative agreement with Royal Philips (NYSE:PHG) sleep and respiratory care subsidiary Philips Respironics. The agreement covers Philips’ iNeb aerosol drug delivery device and Mast’s lead product candidate, AIR001, a sodium nitrite solution for intermittent inhalation. The iNeb system is a portable, small vibrating mesh technology […]
Physicists develop first artificial cell-like vesicles from natural proteins
Researchers at Saarland University in Saarbrücken, Germany have developed cell-like vesicles made from a bilayer of naturally occuring proteins that can be used in an aqueous or an oil-based environment. The team was characterizing naturally occurring proteins called hydrophobins when they observed a strange behavior. “We noticed that the hydrophobins form colonies when they are placed in […]
Physics-modeling software solves drug-delivery engineering problem
Software that models the laws of physics is usually used by theoretical physicists. But a multi-physics program based on “1st principles” can be used in real-world applications, as evidenced by a problem that cropped up for Eli Lilly (NYSE:LLY) while developing needle-based drug-delivery systems. Bernard McGarvey, a senior engineering advisor for the US pharma giant, said the […]
Aerogen touts study of Solo vibrating mesh for aerosol drug delivery
Aerogen today touted results from a study showing a 32% reduction in hospital admissions when patients were treated using its Solo vibrating mesh aerosol drug delivery system, compared to a small-volume nebulizer. The Chicago-based company’s vibrating mesh is used to treat respiratory disorders such as COPD, asthma, or influenza, all of which are exacerbated in the […]
Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial
Intersect ENT (NSDQ:XENT) said today that its Resolve sinus implant met both primary endpoints in the Resolve II pivotal trial. The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure. The study evaluated the change […]
FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe
Genentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes. The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion. The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company […]
Researchers look to create massive human cell ‘atlas’
Scientists launched a global initiative on Friday to map out and describe every cell in the human body in a vast atlas that could transform researchers’ understanding of human development and disease. The atlas, which could take more than a decade to complete, aims to chart the types and properties of all human cells across all […]