MedinCell announced that its long-acting injectable malaria treatment is ready to enter into the stages of regulatory development. Montpellier, France–based MedinCell conducted an in vivo proof of concept on cattle that demonstrated three-month mosquitocidal effectiveness in the injectable, long-acting formulation of Ivermectin using the company’s BEPO delivery technology. The company designed the investigational mdc-STM product […]
Pharmaceuticals
FDA extends NDA review period for Incyte’s atopic dermatitis therapeutic cream
Incyte (NSDQ:INCY) announced today that the FDA extended the review period for the new drug application for its ruxolitinib cream. Wilmington, Del.-based Incyte designed its ruxolitinib cream to treat atopic dermatitis (AD). The company designed the proprietary formulation of its selective JAK1/JAK2 inhibitor ruxolitinib for topical application, according to a news release. Currently, the ruxolitinib […]
Cardinal Health wins new FDA approval for Lymphoseek
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. Dublin, Ohio-based Cardinal Health touts Lymphoseek — acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016 — as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). The new indication will expand […]
Ananda Scientific enrolls first patient in Liquid Structure CBD trial for treating PTSD
Ananda Scientific announced today that it enrolled the first patient in a trial evaluating its Liquid Structure delivery system for treating PTSD. In collaboration with the NYU Grossman School of Medicine, Ananda’s clinical trial will evaluate Nantheia A1002N5S, an investigational drug that uses cannabidiol (CBD) in Ananda’s proprietary Liquid Structure delivery technology to treat post-traumatic […]
BD surpasses 2 billion orders for COVID-19 vaccine injection devices
BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts. Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices. The order total encompasses commitments to governments all over the globe, including the U.S., […]
GM Instruments, Sensonics partner on nasal and oral measurement devices
GM Instruments announced today that it partnered with Sensonics to develop devices for the quantitative assessment of nasal and oral function. The companies tout the first-of-its-kind partnership as a bringing together of sensory and engineering expertise for evaluating and treating nasal and oral diseases. Additionally, the companies expect the partnership to establish the influences of […]
FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health
Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere. Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of […]
Lyra inks $135M partnership to expand chronic rhinosinusitis treatment in Asia
Lyra Therapeutics (NSDQ:LYRA) announced today that it entered into a strategic partnership with LianBio for its LYR-210 treatment for chronic rhinosinusitis. Watertown, Mass.–based Lyra, which develops the LYR-210 therapeutic to be locally delivered by its proprietary XTreo platform, could receive up to $135 million in total payments through the strategic partnership and exclusive license agreement […]
NRx Pharmaceuticals touts Zyesami results, seeks EUA for treating COVID-19
NRx Pharmaceuticals (NSDQ:NRXP) announced that it applied for FDA emergency use authorization based on a study of its Zyesami therapeutic. Radnor, Pa.-based NRx Pharmaceuticals, formerly NeuroRx, just last week completed a merger with SPAC Big Rock Partners Acquisition Corp. and went public, changing its name in the process. The company develops Zyesami, a synthetic form […]
Phillips-Medisize unveils Aria smart autoinjector
Phillips-Medisize today unveiled the Aria smart autoinjector platform designed to elevate patient care and reduce environmental impact. Hudson, Wis.–based Phillips-Medisize, a Molex company, said in a news release that the Aria platform introduces a small, simple smart injection device with a reusable electronic drive unit and single-use, disposable cassettes. The company designed the Aria autoinjector […]
