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). Get the full story at our […]
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 […]
Cancer diagnostic detects unique mutations in small amount of blood
Researchers from Stanford University have developed a new diagnostic tool that can detect genetic mutations in small amounts of tumor-derived DNA circulating in a patient’s blood sample. The single color digital PCR assay needs a fraction of a tube of blood and can successfully detect three mutation-bearing molecules in a single reaction, according to the report published […]
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. Get the […]
Study: Opioid-related deaths overwhelming intensive care units
Intensive care units in hospitals have seen a sharp increase in the number of opioid-related admissions and deaths since 2009, according to a study by researchers at Beth Israel Deaconess Medical Center, and the demand for care relating to opioids has overwhelmed the available supply. The team touted their study, which was published today in the Annals […]
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 to […]
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. Get the full story at our sister […]
Merck CEO Frazier leaves Trump council
Merck (NYSE:MRK) announced today that chief executive Kenneth Frazier plans to resign from President Donald Trump’s American Manufacturing Council, citing the president’s mild-mannered response to a white nationalist rally in Virginia on Saturday. The “Unite The Right” gathering turned deadly when a car mowed down a group of counter-protesters, killing at least one person and injuring […]
SteadyMed tops Q2 sales, EPS 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 of […]
Trump declares national emergency over opioid epidemic
President Trump said yesterday that he is preparing to declare the opioid epidemic a national emergency. This is a reversal from an announcement made earlier this week by Health and Human Services Secretary Tom Price, who said that they would not declare a state of emergency. “The opioid crisis is an emergency, and I’m saying […]