Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine. The company expects to start enrolling patients in the pivotal trial in the second half of this year. […]
Clinical Trials
Anika shares plummet after Phase III trial misses endpoint
Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients […]
Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis. In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan‘s (NSDQ:MYL) EpiPen auto-injector. “Because epinephrine is […]
Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva. Pulmatrix used salt-based excipients and spray-drying techniques as part of its iSperse drug-delivery platform to […]
Reva Medical’s Fantom bioresorbable scaffold succeeds in two-year trial
Reva Medical (ASX:RVA) touted sustained safety and efficacy results for its Fantom bioresorbable scaffold at this year’s EuroPCR meeting. The company also revealed new information about its suite of Fantom Encore products, noting that the devices will have strut profiles of 95 microns, 105 microns and 115 microns. Reva’s Fantom II trial included 240 patients and […]
Biotronik touts two-year study comparing drug-eluting stents
Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of […]
EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis
At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSX touted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon. The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting […]
Beta Bionics wins FDA nod for home-use trial of artificial pancreas tech
Beta Bionics said this week that it won FDA approval to start recruiting patients with Type I diabetes for home-use studies of its iLet bionic pancreas system. The trial is slated to test Novo Nordisk’s fast-acting insulin, Fiasp, with the company’s autonomous infusion pump in adults with Type I diabetes. The study will also evaluate […]
GlaxoSmithKline touts long-term study of biologic treatment for severe eosinophilic asthma
GlaxoSmithKline (NYSE:GSK) touted new data today from a long-term study of its biologic treatment for patients with severe eosinophilic asthma. One-third of patients treated with mepolizumab experienced no exacerbations, GSK reported – down from an average of two exacerbations each year at the start of the study. The 347-patient Columba trial gave participants 100-mg of mepolizumab […]
With groundbreaking approval, Amgen launches new class of medicine for migraine patients
Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults. The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) […]