Opthea (ASX:OPT) touted additional data today from the Phase I/IIa trial of its wet age-related macular degeneration therapy, OPT-302. The 50-patient Phase I/IIa trial recruited participants who were either treatment-naive or previously treated with an intravitreal anti-VEGF therapy. Researchers evaluated OPT-302 as a monotherapy and in combination with Lucentis (ranibizumab). In treatment-naive patients who received OPT-302 […]
Drug-Device Combinations
Tandem launches pivotal trial for predictive insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it enrolled the first patient in an at-home pivotal trial of its t:slim X2 insulin pump combined with the company’s predictive low glucose suspend algorithm. Using DexCom’s G5 mobile continuous glucose monitor and Tandem’s predictive technology, the insulin pump is designed to halt insulin delivery when it predicts low […]
Manufacturing drug device products: challenges and best practices
Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
BioTime lands $2m for dry-AMD therapy
BioTime Inc. (NYSE:BTX) said today that its subsidiary, Cell Cure Neurosciences, has landed a $2 million grant from the Israel Innovation Authority for the development of its dry-AMD therapy, OpRegen. The Alameda, Calif.-based company’s OpRegen is an investigational therapy that delivers retinal pigment epithelial cells into the subretinal space to replace lost RPE cells. “This new […]
Ophthotech eye-drug trial fails to meet primary endpoint
Shares in Ophthotech (NSDQ:OPHT) dipped to $2.46 apiece this morning after the company announced that its Phase III wet age-related macular degeneration trial failed to meet its primary endpoint. The New York-based company said that the addition of Fovista (pegpleranib) to Eylea or Avastin, both anti-VEGF therapies, did not significantly improve visual acuity after 12-months compared […]
Medtronic launches DAPT study for Resolute Onyx DES
Medtronic (NYSE:MDT) said today that it’s launching a study of dual anti-platelet therapy and its Resolute Onyx drug-eluting stent. The 2,000-patient study is designed to compare a one-month course of aspirin and an anti-coagulant in conjunction with the Resolute Onyx device or the BioFreedom DES made by Biosensors International (PINK:BSNRY). The Resolute Onyx stent is made […]
Pavmed beats Q2 EPS by a penny
Medical device maker Pavmed Inc. (NSDQ:PAVM) topped expectations on Wall Street with its second quarter results today. The New York-based company posted a net loss of -$989,707, or -8¢ per share, for the 3 months ended June 30, for bottom-line growth of 25% compared with the same period last year. Adjusted to exclude 1-time items, earnings per […]
SteadyMed tops Q2 sales estimates
Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates. The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth […]
Cytori Therapeutics posts mixed Q2
Shares in Cytori Therapeutics (NSDQ:CYTX) fell today after the biotech missed sales expectations on Wall Street with its second quarter results, but topped EPS estimates. The San Diego, Calif.-based company posted a net loss of -$6 million on sales of $1.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales […]
MIT researchers developing device to pump drugs to the brain
Researchers at the Massachusetts Institute of Technology are developing a pump to deliver drugs directly to the brain. Alejandro Aponte, a mechanical engineering major at the University of Puerto Rico, has spent his summer working with Michael Cima, a professor of engineering, as part of MIT’s Summer Scholars program. The team’s pump prototype is attached […]