The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
Novaliq touts topline data for dry eye disease drug
Novaliq today touted topline data from the first pivotal trial of its CyclASol 0.1% drug designed to treat dry eye disease. The company is hoping to position its 0.1% cyclosporine A product as advantageous compared to other ophthalmic treatments, noting that its EyeSol technology helps boost the drug’s efficacy and provide an earlier onset of […]
Report: Next-gen Amazon Alexa could detect illness, provide medicine suggestions
Future generations of Amazon‘s (NSDQ:AMZN) Alexa virtual assistant may be able to determine when its users are ill and provide medication recommendations, according to a new report from The Telegraph. The online retail giant has reportedly patented a new version of Alexa designed to analyze speech and identify signs of illness, according to the report. […]
Philips’ HealthSuite will track Ypsomed’s connected self-medication devices
Philips and Ypsomed said today that they will jointly develop a solution for Ypsomed’s new self-medication adherence monitoring services based on Philips’ HealthSuite digital platform. The combination of Ypsomed’s connected devices and Philips’ (NYSE:PHG) cloud-based digital platform will allow Ypsomed’s pharmaceutical customers to deliver value-added services aimed at improving patient outcomes, the companies said in […]
J&J inks collab deal to develop MERS vaccine
Healthcare giant Johnson & Johnson (NYSE:JNJ) today announced a new collaborative deal as it looks to develop a vaccine against Middle East Respiratory Syndrome Coronavirus. The collaborative deal is between J&J’s Janssen Vaccines & Prevention division, the Coalition for Epidemic Preparedness Innovations and The Jenner Institute at the University of Oxford, J&J said. Through the deal, Janssen […]
NIH kicks off study of combo antibody HIV therapy
The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV. The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the […]
EyeGate’s Phase 3 EGP-437 study fails to show non-inferiority
Ophthalmalogical-focused developer EyeGate Pharma said this week that the Phase 3 study of its EGP-437 delivered through its EyeGate II drug delivery system did not show non-inferiority to the prednisolone acetate ophthalmic solution control group. The Phase 3 study was evaluating the safety and efficacy of the EGP-437 with the EyeGate II in patients with […]
Fujifilm backs therapeutic administration dev Suono Bio
Suono Bio said today that Fujifilm (TSE:4901) made an undisclosed investment in the company to support its next-gen technology intended for the rapid, formulation-independent administration of therapeutics. The Cambridge, Mass.-based company, formed last year by researchers out of the Massachusetts Institute of Technology and Brigham & Women’s Hospital, is developing technology intended for the rapid local administration of […]
Evidation, Tidepool pool resources on diabetes behavior study
Health measurement company Evidation Health and diabetes data firm Tidepool have launched a research program to study real-world data from people with type 1 diabetes. The T1D Sleep Pilot will develop insights from data generated by continuous glucose monitors and insulin pumps, in addition to sleep and activity trackers from smartphones and other connected sensors. The observational […]
Lessons learned: How Jeff Karp stays at the forefront of innovation
Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly. To learn about the exciting technologies emerging from Karp’s lab, join us at DeviceTalks Boston on Oct. 8-10. After Jeff finished his PhD in chemical and biomedical engineering at the University of Toronto, he knew he wanted […]
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