An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]
Medtronic’s SynchroMed woes delay United Therapeutic’s Remodulin
Shares in United Therapeutics (NSDQ:UTHR) fell -3% yesterday on a possible delay for the release of a programmable infusion pump for its drug, Remodulin. Yesterday, the FDA updated Medtronic‘s (NYSE:MDT) Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps. RBC Capital reportedly said the recall puts United Therapeutics at heightened risk for […]
Prometra micro-infusion device used to deliver meds directly to brain in epilepsy trial
Flowonix Medical and Cerebral Therapeutics said today that the 1st patients were implanted with the Prometra II programmable infusion system in a clinical trial evaluating the pump in patients with refractory epilepsy. The Address trial marks the 1st time a programmable, implantable pump has been used to deliver medication, in this case valproate, directly to […]
Ocular touts patient experience data for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) touted data today from a patient experience study of its Dextenza post-surgical pain relief implant. The study was published in Patient Preference and Adherence. The Bedford, Mass.-based company’s hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery. After the […]
FDA announces updates to Medtronic’s Class I recall for SynchroMed drug pumps
The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity. The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for […]
Pacira touts Phase IV study of Exparel anesthetic in total knee arthroplasty
Pacira Pharmaceuticals (NSDQ:PCRX) said today the Phase IV study of its Exparel bupivacaine liposome injection in patients undergoing total knee arthroplasty met its co-primary endpoints for postsurgical pain and opioid reduction. The anesthetic achieved statistical significance for secondary endpoints including time to 1st opioid use and the percentage of patients who did not require opioids […]
Trump’s pick for FDA chief faces questions over ties to drug industry
Although President Donald Trump’s nominee for FDA commissioner has won approval from lawmakers across the aisle, he is facing questions from consumer watchdog Public Citizen over his ties to the drug industry that will likely arise during his confirmation hearings. The Medical Device Manufacturer Association has voiced its approval for Scott Gottlieb, saying “Dr. Gottlieb is a […]
Scientists develop microjet device for needle-free vaccine delivery
Researchers from the University of California Berkeley have developed a needle-free delivery device for vaccines. The team published their work in Science Translational Medicine. The MucoJet device is a pill that releases its cargo in a microjet when pressed up against the cheek. The pressure generated from pushing the device against the cheek is enough to […]
Sanofi, Voluntis ink deal for digital insulin management system for T2D
Sanofi (NYSE:SNY) and Voluntis said today that the groups inked a non-exclusive agreement to bring digital insulin management systems for Type II diabetes to the U.S. and several European countries. The companies 1st established in alliance in 2011, developing a mobile phone application that was designed to improve decision-making and self-management of patients with Type II […]
Senate confirms Verma to head CMS as debate intensifies over Obamacare replacement
The U.S. Senate voted yesterday 55-43 to confirm Seema Verma to head the Centers for Medicare and Medicaid Services. Verma is the founder & CEO of SVC Inc, a healthcare consulting firm, and worked with now-Vice President Mike Pence when he was governor of Indiana to redesign the state’s Medicaid program. Get the full story […]