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. Get the full story […]
Food & Drug Administration (FDA)
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 […]
Nephros wins FDA nod for EndoPur endotoxin dialysis filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its EndoPur 10″ endotoxin filter designed for dialysis systems. The River Edge, N.J.-based company said the newly cleared EndoPur 10″ filter is designed to produce hemodialysis quality water for dialysis systems, and fits into existing filter cartridge housings. Nephros touted the device as having the smallest […]
FDA approval in hand, Tryton Medical inks distro deal with Cardinal Health’s Cordis
Tryton Medical said today that it won pre-market approval from the FDA for its its side-branch stent for treating coronary bifurcation lesions and has already inked an exclusive U.S. distribution deal withCardinal Health (NYSE:CAH) subsidiary Cordis. The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes in sizes […]
Analysis: 5 ways Trump is making things uncertain for medtech
Want a word to sum up 2017? Try “uncertainty.” Chris Newmarker, Managing Editor Wall Street investors remain on a sugar high from the new Trump administration and Republican Congress. The Dow Jones Industrial Average is up hundreds of points since President Donald Trump’s promise to a joint session of Congress on Tuesday that he wanted to […]
Neocis wins FDA nod for 1st dental robotic guidance system
Robotic medical device developer Neocis said today it won FDA 510(k) clearance for its Yomi robotic guidance system for dental implant procedures, touting it as the 1st of its kind to win a nod from the federal watchdog. The Yomi is a computerized navigational system designed to assist in both pre and intra-operative phases of […]
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. […]
Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s NanoFuse BA is a composite of bioactive glass and a human demineralized bone matrix that Amend Surgical touts as providing optimal surgical handling performance […]
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 releases January 2017 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2017 TOTAL 510(k)s THIS PERIOD 222 TOTAL WITH SUMMARIES 203 TOTAL WITH STATEMENTS 19 DEVICE: Love Alchemy’s Love Lotion LOVE ALCHEMY LLC 510(k) NO: K151857(Traditional) ATTN: Eric Weiss PHONE NO : 421 KINGSLEY AVE #200 SE DECISION MADE: 09-JAN-17 ORANGE PARK FL […]