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 […]
Sales for Reva Medical up in Q3 following launch of bioresorbable scaffold
Shares in Reva Medical (ASX:RVA) rose today after the medical device maker posted its third-quarter financial results. The San Diego, Calif.-based company recorded a net loss of -$9 million on sales of $93,000 for the 3 months ended Sept. 30, for sales growth of 447% compared with the same period last year. Earnings per share were […]
Intersect ENT tops estimates with Q3 results
Shares in Intersect ENT (NSDQ:XENT) fell today even though the medical device maker topped expectations on Wall Street with its third-quarter financial results. The Menlo Park, Calif.-based company posted a net loss of -$7.6 million on sales of $24.7 million for the 3 months ended Sept. 30, for sales growth of 11% compared with the same period […]
Medherant touts results for ibuprofen transdermal patch
Medherant said today that it successfully finished two Phase I studies with its ibuprofen transdermal drug-delivery patch. According to the UK-based company, the Tepi patch was well tolerated by the participants of a skin irritation study. The company also touted results from a second study, which compared blood concentrations of ibuprofen following repeated application of […]
Clearside Biomedical’s combo therapy fails in Ph3 retinal vein occlusion trial
Clearside Biomedical (NSDQ:CLSD) said today that its lead drug, in combination with Regeneron‘s (NSDQ:REGN) Eylea, failed in a phase III retinal vein occlusion trial. The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks. […]
FDA to develop new framework for opioid analgesics following AcelRx approval
The FDA last week approved AcelRx‘s (NSDQ:ACRX) Dsuvia sufentanil product, noting that use of the opioid will be tightly restricted to adults experiencing acute pain in medically-supervised healthcare settings. Dsuvia is a tablet that is administered sublingually in a single-dose, pre-filled applicator. The company expects to launch its pain product in the first quarter of […]
Aquestive wins FDA nod for seizure oral film
Shares in Aquestive Therapeutics (NSDQ:AQST) rose today after the company announced FDA approval for its Sympazan oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. The clobazam oral film is the first product of its kind to be approved by the FDA as a treatment for seizures associated with LGS, according to […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The […]
Janssen touts topline data for long-acting, injectable HIV therapy
Johnson & Johnson‘s (NYSE:JNJ) Janssen touted topline results this week from a Phase III trial of its long-acting, injectable two-drug regimen for the treatment of HIV. The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance […]
