The FDA this week approved Amphastar Pharmaceuticals‘ (NSDQ:AMPH) over-the-counter Primatene Mist inhaler for the temporary relief of mild symptoms of intermittent asthma. The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone […]
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Ocular Therapeutix shares fall after Q3 earnings miss
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the company missed EPS estimates on Wall Street with its third-quarter financial results. The Bedford, Mass.-based company posted a net loss of -$15 million on sales of $498,000 for the 3 months ended Sept. 30. Sales for the quarter were down -5% compared with the same period last year. Earnings […]
VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon
By Sarah Faulkner & Fink Densford Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. All of the study’s 13 subjects met the acute success measures of safety at […]
Insulet inks deal with Samsung to develop smartphone-controlled Omnipod
Insulet (NSDQ:PODD) said this week that it inked a deal with Samsung to develop an Omnipod insulin delivery system that would allow users to control their insulin pump therapy with a Galaxy smartphone. If approved, the system would be the first of its kind, according to the Billerica, Mass.-based company. All Samsung mobile devices are built […]
TriSalus touts data for pressure-enabled drug-delivery tech
TriSalus Life Sciences touted results today from a Phase Ib trial of its pressure-enabled drug-delivery tech for immunotherapy. The company reported that delivering a concentrated dose of CAR-T cells at the site of a solid tumor using its technology was safe and contributed to positive clinical results. In the early-stage trial, five patients with carcinoembryonic […]
Senseonics wins another FDA approval for its implantable CGM
Senseonics (NYSE:SENS) said this week that it won another FDA approval for its implantable continuous glucose monitoring system, giving nurse practitioners and physicians assistants the ability to implant and remove the Eversense device. When the product was first approved by the FDA in June, only trained physicians were allowed to conduct the sensor insertion and removal […]
Dexcom raises outlook after Q3 results top Wall Street estimates
Dexcom (NSDQ:DXCM) raised its full-year outlook yesterday after the medical device maker topped expectations on Wall Street with its third-quarter financial results. The San Diego, Calif.-based company posted profits of $46.6 million, or 53¢ per share, on sales of $266.7 million for the 3 months ended Sept. 30, for sales growth of 44% compared with the […]
Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions
Boston Scientific (NYSE:BSX) touted one-year data today from an analysis of its Eluvia drug-eluting vascular stent system, showing that the device is safe and effective in patients with long, complex, calcified lesions. The data were presented by Boston Scientific at the annual Vascular Interventional Advances meeting. The company’s Imperial trial included a 50-patient, single-arm analysis of Eluvia […]
Medtronic touts five-year data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) today touted five-year data for its In.Pact Admiral drug-coated balloon, highlighting the durability and efficacy of its device in people with peripheral artery disease in the superficial femoral and popliteal arteries. The company presented five-year results from its pivotal In.Pact SFA trial at the 2018 Vascular Interventional Advances conference. “Since the entrance of DCBs […]
OncoSec shares fall on preliminary data from skin cancer trial
Shares in OncoSec Medical (NSDQ:ONCS) fell nearly -60% this morning after the company revealed preliminary data from its Phase IIb trial of intratumoral delivery of Tavo in people with unresectable, advanced melanoma. OncoSec’s lead product, Tavo, uses electroporation to deliver IL-12 directly into a patient’s tumor, triggering an immune response. As of Sept. 1, 21 people […]