Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. “Physicians are looking for a technology that is minimally invasive and also curative,” principal investigator […]
Novocure touts top-line data from Ph2 mesothelioma trial
Novocure (NSDQ:NVCR) today touted positive top-line data from its Phase II pilot mesothelioma trial and revealed that it plans to submit a humanitarian device exemption application to the FDA for approval. The St. Helier, N.J.-based company reported that patients who received treatment with its “Tumor Treating Fields” system plus chemotherapy experienced clinically meaningful improvements in overall […]
Avita Medical touts pivotal trial of ReCell burn injury device
Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints. The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted. “Treatment with the ReCell device […]
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
FDA refuses to review application for Alkermes’ depression drug
Alkermes (NSDQ:ALKS) shares tumbled this morning after the company revealed that the FDA will not review its application for an investigational depression drug. The U.S. regulatory issued a refusal to file letter to Alkermes, writing that it can’t review the drug’s application based on “insufficient evidence of overall effectiveness for the proposed indication,” and that […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
Kala Pharmaceuticals posts Q4 earnings miss
Shares in Kala Pharmaceuticals (NSDQ:KALA) tumbled -14% yesterday after the biopharma company missed expectations on Wall Street with its fourth-quarter and full-year results. The Waltham, Mass.-based company posted a net loss of -$11.3 million, or -46¢ per share, for the 3 months ended Dec. 31, for bottom-line loss of -34.5% compared with the same period last year. […]
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine. Novo Nordisk’s Devote trial met its primary endpoint after Tresiba demonstrated […]
NIH study finds islet transplants improve quality of life for people with Type I diabetes
A Phase III trial funded by the National Institutes of Health found that quality of life for people with type I diabetes improved dramatically following transplantation of insulin-producing pancreatic islets, according to data published this week in the journal Diabetes Care. The 48-patient trial involved participants with hypoglycemia unawareness, a condition that renders them unable to […]
Ocugen touts Ph2 data for dry eye disease combo therapy
Ocugen touted positive data today from a Phase II proof-of-concept trial for its dry eye disease combination therapy, OCU310, which combines brimondine tartrate and loteprednol etabonate. The company’s randomized trial met its primary tolerability endpoint and showed meaningful improvements across endpoints related to the symptoms of dry eye disease, according to Ocugen. The Malvern, Pa.-based […]
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