KemPharm (NSDQ:KMPH) touted top-line data from a pivotal efficacy and safety trial of its KP415 pediatric ADHD product. The company reported that KP415, which consists of serdexmethylphenidate and d-methylphenidate, met the primary efficacy endpoint in people with attention-deficit/hyperactivity disorder between the ages of 6 and 12 years. KemPharm’s KP415 capsule makes use of d-MPH hydrochloride as […]
Clinical Trials
Vaccine maker PaxVax tackles the unmet need posed by chikungunya virus
Transmitted by the same mosquitoes that spread Zika virus and dengue fever, the chikungunya virus is named for an African word meaning “to become contorted.” People infected with the alphavirus are afflicted with lasting joint pain that causes their backs to hunch over, according to the World Health Organization. The virus, which has cropped up […]
Siga Technologies touts pivotal data for oral smallpox therapy
Siga Technologies (NSDQ:SIGA) said today that data from a pivotal human safety study and animal efficacy studies of its oral smallpox therapy were published in the New England Journal of Medicine. Data from the studies support the efficacy and favorable safety profile of Tpoxx, an oral formulation of tecovirimat. “Smallpox is both highly contagious and highly […]
Ocugen launches Ph3 trial for eye disease nanoemulsion
Ocugen said today that it launched the first of two pivotal Phase III trials for its OCU300 nanoemulsion designed to treat the symptoms of ocular graft versus host disease. The Malvern, Penn.-based company’s drug is a nanoemulsion formulation of brimonidine tartrate made using Ocugen’s OcuNanoE technology. Ocugen touted that it’s the first company to bring […]
Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding
Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth. Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent […]
Eli Lilly touts data for concentrated insulin delivered via Insulet’s Omnipod tech
Eli Lilly (NYSE:LLY) touted data this week from a Phase III study evaluating its Humulin R U-500 concentrated insulin delivered via Insulet‘s (NSDQ:PODD) investigational Omnipod U-500 device. The company reported that people with Type II diabetes taking Humulin R U-500 using the Omnipod device experienced greater A1c reductions and needed less daily insulin compared to adults […]
Enteris BioPharma touts more Phase II data for oral endometriosis therapy
Enteris BioPharma this week touted positive results from the final treatment arm of a Phase IIa trial of Ovarest, the company’s oral formulation of leuprolide. The drug is designed as an alternative to the injectable therapies available for people with endometriosis. Data from the last treatment arm of Enteris’ Phase IIa trial showed that the optimized […]
Closed-loop insulin delivery systems shine at annual diabetes meeting
As device-makers, healthcare practitioners and people with diabetes convened at this year’s annual meeting of the American Diabetes Association, one major theme emerged: the industry is catching on to the potential of closed-loop insulin delivery systems. Major medical technology companies, including Medtronic and Insulet, touted data at this year’s meeting demonstrating the benefits of their […]
Valeritas touts positive results for V-Go wearable insulin delivery device
Valeritas (NSDQ:VLRX) shares jumped this morning after the company touted positive results from its Enable study, showing that patients who switched from insulin pens and syringes to the company’s wearable V-Go insulin delivery device experienced improved blood glucose levels and lowered their daily insulin dose. The company presented three posters at this year’s meeting of the […]
Impel NeuroPharma readies trial for intranasal drug-device migraine treatment
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. […]