Clearside Biomedical (NSDQ:CLSD) shares soared more than 50% in pre-market activity today after the company reported that its suprachoroidal eye drug succeeded in a pivotal Phase III trial of patients with macular edema associated with non-infectious uveitis. The company’s drug, CLS-TA, is a proprietary suspension of a corticosteroid, triamcinolone acetonide, designed to be administered to the […]
Clinical Trials
Lilly touts Ph3 data for once-weekly Type II diabetes medication
Eli Lilly (NYSE:LLY) touted data today from a Phase IIIb study of its once-weekly, injectable Type II diabetes medication, Trulicity. The insulin-maker reported that its GLP-1 receptor agonist significantly improved blood sugar control in people with Type II diabetes when added to ongoing treatment with a SGLT-2 inhibitor. “I’ve seen in my practice that even with […]
Novo Nordisk touts promising results from late-stage trial of oral diabetes med
Setting the stage for a battle with rival Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) reported data this week from a late-stage trial of its oral formulation of semaglutide, a medication for people with Type II diabetes. The GLP-1 agonist is traditionally administered via injection. Both insulin-makers have approved versions of the injectable semaglutide, but Novo Nordisk is […]
Senseonics’ implantable glucose monitor succeeds in 90-day trial
A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics. The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data […]
PharmaJet, Genexine ink deal for needle-free vaccine development
PharmaJet said today it inked a global license agreement with South Korean bioptherapeutics company Genexine to develop and commercialize DNA vaccines using PharmaJet’s needle-free injection system. Through the deal, Genexine will gain access to use both the PharmaJet Stratis and Tropis devices for their Phase I and Phase IIa human clinical studies. The deal also […]
Medtronic looks to expand MiniMed 670G into pediatric diabetes
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. […]
After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA
More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It’s a long-awaited milestone for Dr. Evan Loh, who serves as president, COO and CMO of Paratek Pharmaceuticals (NSDQ:PRTK), the company developing and commercializing omadacycline. It’s also emblematic of […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not […]
Pulmatrix doses first patient in Ph1 Pulmazole trial
Pulmatrix (NSDQ:PULM) said today that the first patient was treated in a first-in-human study of Pulmazole – an inhaled formulation of the anti-fungal drug, itraconazole. The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis. Patients with ABPA are usually given oral […]
Rebiotix develops tool to measure rehabilitation of microbiome
Rebiotix today unveiled its Microbiome Health Index – a tool it created to establish a standard metric that can be used to quantify how effective a microbiome-based therapy is at rehabilitating the human microbiome. The index, which was developed in partnership with data analytics firm BioRankings, combines four bacterial classes into a unidimensional expression of […]