Top-line results from a head-to-head trial comparing Boston Scientific‘s (NYSE:BSX) Ranger drug-coated balloon and Medtronic‘s (NYSE:MDT) In.Pact Admiral DCB found no statistically significant difference in patency rates between the two drug-device products. The trial is the first of its kind, according to Boston Scientific’s president of peripheral interventions, Jeff Mirviss. “As a leader in the […]
Pharmaceuticals
Verily, Sanofi and other industry players team up with NIH to advance Parkinson’s therapies
The National Institutes of Health is joining forces with the tech and pharmaceutical industries to speed the development of new drugs for Parkinson’s disease and identify biomarkers for the debilitating condition. Companies participating in the public-private partnership include Celgene (NSDQ:CELG), GlaxoSmithKline (NYSE:GSK), The Michael J. Fox Foundation for Parkinson’s Research, Pfizer (NYSE:PFE), Sanofi (NYSE:SNY) and Verily. Combined the […]
Ensysce Biosciences wins fast track status for abuse-deterrent oxycodone
Ensysce Biosciences said this week that its extended-release oxycodone prodrug won fast track status from the FDA. The San Diego, Calif.-based company is developing the abuse-deterrent drug as a pain management therapy for people with moderate to severe chronic pain. Ensysce’s prodrugs are only activated once they reach the small intestine, where enzymes set off […]
Sunovion touts pivotal Ph3 trial for Parkinson’s drug
Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that […]
Medtronic’s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis
Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial. The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the […]
Ocular Therapeutix closes $35m offering
Ocular Therapeutix (NSDQ:OCUL) has closed an underwritten public offering of 7,475,000 shares of its common stock at $5.00 apiece, reeling in $35.1 million to fund the planned resubmission of its new drug application for Dextenza, an ocular post-surgical pain-relief implant that was rejected by the FDA last year. The Bedford, Mass.-based company also plans to use its newly-acquired funds […]
NASA scientists take on muscular atrophy with drug-loaded implant
Scientists aboard the International Space Station plan to study if a drug-eluting implant can prevent, slow or even turn back the muscular breakdown observed in astronauts when they fly for an extended period of time. The investigation is designed to test the efficacy of a drug and a nano-channel drug-delivery system in a space-bound mouse […]
FDA to review Theravance’s application for once-daily COPD med
The FDA has accepted Theravance Biopharma‘s (NSDQ:TBPH) marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease. The FDA is slated to make a decision about the once-daily treatment by Nov. 13. “The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized […]
Boehringer Ingelheim inks outcomes-based contract with pharmacy benefit manager for diabetes drug
Boehringer Ingelheim has inked an outcomes-based contract with pharmacy benefit manager Prime Therapeutics for its oral Type II diabetes drug, Jardiance. The medication is designed to cut the risk of cardiovascular death in adult patients with Type II diabetes and established heart disease. As part of Prime’s CareCentered Contracting program, the outcomes-based deal will focus […]
European committee backs Mylan’s insulin glargine biosimilar
Mylan (NSDQ:MYL) and Biocon announced today that a European Medicines Agency committee has recommended approval for its biosimilar insulin glargine, Semglee. The committee’s positive opinion brings the product one step closer to approval. The European Commission is slated to make a final decision in April. “We are pleased with CHMP’s decision to recommend approval of Mylan […]