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 […]
Food & Drug Administration (FDA)
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 […]
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 […]
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 […]
BTG’s Ekos device targets pulmonary embolism with drug, ultrasound wave combo therapy
Each year, pulmonary embolisms kill more people in the U.S. than AIDs and breast cancer combined, according to BTG (LON:BTG). Venous clots in the legs or arm break off and travel through a patient’s circulatory system, eventually getting trapped in the lung and blocking the flow of blood. In some cases, this strains the heart’s ability to […]
Medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes, […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
PolyPid wins FDA designation for antibiotic drug reservoir
Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA. Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity. The D-Plex antibiotic drug reservoir is designed to prevent post-cardiac surgery sternal […]
Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide. The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm. “Respiratory is a core […]
