Dissolvable microneedle patches that deliver the flu vaccine could provide a safe and cost-effective alternative to traditional immunization methods, according to the results from a Phase I trial published in The Lancet this week. The study enrolled adults ages 18 to 49 and randomly assigned them to receive a single dose of inactivated flu vaccine via […]
Drug-Device Combinations
Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial
Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French […]
Semnur touts Phase I/II trial of non-opioid pain-killer
Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain. The trial met its primary endpoint and showed that single epidural injection of SP-102 could provide a sustained analgesic effect for 1 month. The company touted its product, which is […]
BioDelivery wins Health Canada approval for Belbuca pain relief product
BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate daily, long-term opioid treatment and for which alternative management options are inadequate. The company said it plans to commercialize Belbuca in Canada through an unnamed partner and that the launch […]
Ocular Therapeutix founder & CEO Sawhney to step down | Personnel Moves – June 23, 2017
The president & CEO of Ocular Therapeutix (NSDQ:OCUL), Amarpreet Sawhney, is slated to step down from the company that he helped start in 2006. He will serve as the board’s executive chairman for 1 year, unless he decides to leave earlier. The company wrote in a regulatory filing that “his service will be automatically renewed for […]
Medtronic warns on button glitch with MiniMed 640G insulin pump
Medtronic (NYSE:MDT) issued a field safety notice in May, warning users that keypad buttons on its MiniMed 640G insulin pump may become temporarily stuck when the atmospheric pressure around the pump suddenly increases or decreases – like during air travel. If the keypad buttons are stuck, users may not be able to program a bolus or […]
Insulin management software wins FDA nod
Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower […]
Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]