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 […]
Food & Drug Administration (FDA)
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 […]
Intersect ENT seeks FDA nod for Resolve steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it submitted a New Drug Application to the FDA for its Resolve steroid-releasing implant to treat chronic sinusitis patients with recurrent sinus obstruction. The Menlo Park, Calif.-based company’s implant can be placed during a routine physician office visit and is designed to be a less invasive treatment option for recurrent […]
EnGeneIC wins orphan drug designation for targeted nanocells
EnGeneIC said today that the FDA granted orphan drug designation to the company’s targeted EDV nanocells for the treatment of glioblastoma multiforme. The clinical stage biopharmaceutical company is developing bacterially-derived EDV nanocells as a nanoparticle, siRNA and miRNA delivery platform designed to target and kill tumor cells, while triggering the immune system’s natural anti-tumor response. […]
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
Trump calls for speedier approval process, while Sanders takes aim at drug prices
In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation of prescription drugs from Canada in the hopes of lowering drug prices. The new administration has been critical of drug prices, with Trump saying that […]
FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog. After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole […]
