Halo Pharma launched its Pediatic Center of Excellence today to support the development and manufacturing of drugs tailored for pediatric indications. The company said it will use the manufacturing facility to continue working with pharmaceutical companies to develop pediatric dosage forms of already-approved adult drugs. When the FDA requests that a company conduct clinical trials for […]
Pharmaceuticals
Nobilis, Submersible Systems to develop hand-held inhalation device for neurological drugs
Nobilis Therapeutics said today that it partnered with device manufacturer Submersible Systems to develop a portable, hand-held inhalation device that administers a xenon gas-based therapeutic, NBTX-001. The companies said they are working on customizing and testing the drug-device combination. The group plans to pursue regulatory approval with the FDA, supported by upcoming clinical trials in […]
Patients with Parkinson’s disease help shape clinical trial design
Margaret Sheehan isn’t a scientist, but she is 1 of many patient scientists joining an effort to incorporate Parkinson’s patients’ preference into the design of clinical trials for new treatments. Sheehan, a Virginia-based lawyer, has had Parkinson’s disease since 2004. She told Drug Delivery Business News that when the folks at the Medical Device Innovation Consortium presented last spring […]
Mylan beats Q1 earnings by a penny, misses on revenue
Shares in Mylan (NSDQ:MYL) rose 2% in pre-market activity today after the EpiPen maker beat earnings expectations on Wall Street with its 1st quarter results. The Canonsburg, Penn.-based company posted profits of $66.4 million, or 12¢ per share, on sales of $2.72 billion for the 3 months ended March 31, for bottom-line growth of 377.7% on sales growth […]
Researchers combine modified insulin and red blood cells to regulate blood sugar in diabetic mice
Researchers from North Carolina State University and the University of North Carolina at Chapel Hill have designed a glucose-responsive “smart” insulin delivery system using modified insulin and red blood cells. In an animal study of mice with Type I diabetes, the system effectively reduced blood sugar levels for 48 hours. The team’s work was published […]
OptiNose raises $37m in Series D for commercial efforts
OptiNose said today that it closed a $37 million Series D round led by Fidelity Management and Research Company. Avista Capital Partners, Entrepreneurs Fund and other current investors also contributed to the round. The Yardley, Penn.-based company said it plans to use the newly-acquired funds to support commercial development of its lead product candidate, OPN-375, […]
Catalent soars on Q3 earnings, sales beat
Shares in Catalent (NYSE:CTLT) jumped more than 20% last week after the company beat expectations on Wall Street with its fiscal 3rd quarter results. The Somersert, N.J.-based company posted profits of $26 million, or 21¢ per share, on sales of $532.6 million for the 3 months ended March 31, for bottom-line growth of 143% on sales growth […]
Valeant posts Q1 profit thanks to tax benefit, raises guidance
Shares in Valeant Pharmaceuticals (NYSE:VRX) rose more than 25% today after the company met earnings expectations on Wall Street, but missed on revenue with its 1st quarter results. The Canada-based company posted profits of $628 million, or $1.79 per share, on sales of $2.11 billion for the 3 months ended March 31, for bottom-line growth […]
Study: pSivida’s Durasert lessens recurrence of uveitis through 12 months
pSivida (NSDQ:PSDV) touted 1-year follow-up data yesterday for the company’s Durasert 3-year treatment of posterior segment uveitis. The data, which was presented at the Association for Research in Vision and Ophthalmology annual meeting, is from pSivida’s 1st phase III trial. The data showed that the 3-year uveitis implant significantly reduced the recurrence of posterior segment uveitis […]
Allergan, Medicines360 tout 4-year pivotal data for Liletta intrauterine contraceptive
Allergan (NYSE:AGN) and women’s health nonprofit pharma company Medicines360 touted 4-year data today from an ongoing pivotal trial for its Liletta intrauterine contraceptive. The system is approved for the prevention of pregnancy for up to 3 years. More than 1,500 women ranging from 16 to 45 years old were enrolled and studied in the group’s […]