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 […]
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FDA approves Bracco’s contrast agent for pediatric CNS imaging
The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old. Data collected in pediatric patients under the age of two showed that a dose of 0.05 […]
BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial
The FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina. The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory […]
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 […]
Varian Medical to pay $1.3B for Sirtex
Varian Medical (NYSE:VAR) yesterday said it agreed to pay nearly $1.3 billion for Australia’s Sirtex Medical (ASX:SRX) and its anti-cancer microspheres. The A$28-per-share offer, which values Sirtex at A$1.59 billion (about $1.28 billion), is slated to close in late May, Palo Alto, Calif.-based Varian said. It’s part of a bid to broaden that company’s oncology portfolio. Sirtex makes […]
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 […]