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 the treatment of macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of the […]
Drug-Device Combinations
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 […]
SEC lawsuit accuses RenovaCare of securities fraud
The biotech RenovaCare (OTCMKTS: RCAR) announced that it has received a civil complaint from the Securities and Exchange Commission (SEC). The SEC accuses Harmel S. Rayat, a controlling shareholder and chair of RenovaCare, of orchestrating a secret promotional campaign to elevate the company’s stock price. The agency claimed that Rayat and RenovaCare worked with the financial publishing […]
Noveome Biotherapeutics inks licensing deal for SipNose drug delivery device
Noveome Biotherapeutics announced that it entered a commercial license agreement to use SipNose’s proprietary drug delivery device. Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release. Get the full story at our […]
Medtronic beats The Street in Q4, Hugo robot wins IDE
Medtronic (NYSE:MDT) had much to tout with its pipeline as it released Street-beating fourth-quarter results. CEO Geoff Martha announced to analysts that FDA has granted the company’s much-anticipated Hugo robot an investigational device exemption approval. Medtronic is preparing to commence its Expand Uro trial in the U.S. to study Hugo in urologic procedures, Martha said […]
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. Get the full story at our […]
Medtronic wins CE mark for smart insulin pen, Guardian 4 sensor
Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor. Fridley, Minn.–based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment decisions, […]
Avalyn Pharma touts study of aerosolized pulmonary fibrosis treatment
Avalyn Pharma announced today that it observed statistically significant success in a study of its aerosolized pulmonary fibrosis treatment. Seattle-based Avalyn presented data from a 24-week Phase 1/2 clinical study at the ISAM conference in Boise, Idaho. The data covered two dose regimens of AP01, a formulation of pirfenidone optimized for delivery through inhalation in patients […]
How Fractyl Labs is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections
Fractyl Labs CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections. Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix. Trained as […]
Giiant Pharma raises $11M for drug delivery platform for gastroenterology
Giiant Pharma announced today that it closed a $11 million seed financing round for its drug delivery technology platform. Montreal-based Giiant develops the Precision Delivery technology platform, which originated from the work of former Merck Frosst scientists, according to a news release. The company designs gut-restricted, tissue-specific, small-molecule drug therapeutics to be delivered through the platform. […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Propel […]