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 […]
Food & Drug Administration (FDA)
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 The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.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 […]
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. “The approval of Propel […]
