GlaxoSmithKline (NYSE:GSK) will not likely face generic competition to its lung drug Advair in the US this year. Yesterday, the FDA denied the application for a 2nd generic competitor. Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes […]
Drug-Device Combinations
Ethicon touts new anti-infection suture guidelines
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon touted updated anti-infection suture guidelines from the Centers for Disease Control and Prevention, which recommend that healthcare professionals “consider the use of triclosan-coated sutures for the prevention of SSI [surgical site infection].” Ethicon Plus Sutures are the only globally available sutures coated with triclosan that stop bacteria commonly associated with […]
OncoSec inks deal with Merck to study drug-device therapy for metastatic melanoma
OncoSec Medical (NSDQ:ONCS) said today that it inked a clinical trial collaboration and supply agreement with Merck (NYSE:MRK) to evaluate the combination of its ImmunoPulse IL-12 electroporation device with Merck’s Keytruda therapy in a Phase II clinical trial. The trial aims to evaluate the drug-device combination in patients with metastatic melanoma – specifically patients who experienced disease […]
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 […]
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 […]
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, […]
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 […]
First uveitis patient treated with Eyevensys’ electro-transfection system
Private biotech Eyevensys said today that it treated the 1st patient in a first-in-human phase I/II trial of its lead candidate, EYS606, for the treatment of non-infectious uveitis. The patient was treated in Paris at the Cochin Institute using the company’s EyeCET technology. The EyeCET platform is an electro-transfection injection system that delivers non-viral plasmids to encode […]
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 […]
Pfizer collaborates to improve access to injectable contraceptive
Pfizer (NYSE:PFE) said yesterday that it inked a multi-year extension of its collaboration with the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation to improve access to the company’s injectable contraceptive, Sayana Press, for women in developing countries. The pharma giant’s product uses Becton Dickinson‘s (NYSE:BDX) Uniject delivery system to administer a long-acting, […]