SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. “The submission of our NDA for Trevyent is the latest in a series of significant […]
Drug-Device Combinations
Sunovion seeks FDA nod for COPD treatment – again
Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application. The U.S. regulatory watchdog is […]
Augmenix debuts SpaceOar in Israel
Augmenix Inc. said this week that it launched its SpaceOar hydrogel device in Israel. The Bedford, Mass.-based company’s absorbable prostate-rectum spacer is designed to reduce rectal injury during prostate radiotherapy. “We are excited to offer our patients this new, innovative technology to significantly reduce risks of prostate cancer radiotherapy,” Dr. Zvi Symon, from the Chaim […]
Windtree Therapeutics reports Phase II data for inhaled surfactant
Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared […]
Dissolvable microneedle patch for flu vaccine succeeds in Phase I
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 […]
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 […]
