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. Get the […]
DarioHealth acquires PsyInnovations for $30M
DarioHealth announced that it entered into an agreement to acquire digital health company PsyInnovations for up to $30 million. PsyInnovations develops the wayForward behavioral digital health platform with AI-enabled screening to triage and navigate members to specific interventions, digital cognitive behavioral therapy (CBT), self-directed care, expert coaching and access to in-person and telehealth provider visits, according […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
Glaukos expands microshunt licensing agreement with Santen Pharmaceuticals
Glaukos (NYSE:GKOS) announced that it entered into a new development and commercialization license agreement with Santen Pharmaceutical. San Clemente, Calif.-based Glaukos’ agreement with Santen Pharmaceutical supersedes the previous collaboration and distribution agreements between the two parties over Santen’s Preserflo MicroShunt, according to a news release. Financial terms of the deal were not disclosed. Santen designed […]
Navidea receives patent for dextran-based drug delivery vehicles
Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it received a patent for its dextran-based drug delivery vehicles. The U.S. Patent and Trademark Office (USPTO) issued U.S. patent 11,007,272 entitled “Compounds and Methods for Diagnosis and Treatment of Viral Infections,” with protection to October 7, 2037, according to a news release. Dublin, Ohio-based Navidea’s patent protects the […]
Interius BioTherapeutics raises $76M Series A
Interius BioTherapeutics announced today that it raised $76 million in an oversubscribed Series A financing round. Philadelphia-based Interius develops treatments for hematologic malignancies. The company’s novel gene delivery platform generates chimeric antigen receptor (CAR) T cells directly in vivo to bypass the need for ex vivo cell manipulations and the potentially toxic pre-conditioning chemotherapy required […]
BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing
BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain. The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release. In December, BD announced its plan to invest […]
Ginkgo Bioworks buys Dutch microbe company ahead of going public
Ginkgo Bioworks announced today that it agreed to acquire fungal platform technology developer Dutch DNA ahead of going public. Last week, the Boston-based cell programming platform developer announced that it was combining with Soaring Eagle Acquisition Corp. to go public. The SPAC values Ginkgo at $15 billion and is expected to provide up to $2.5 […]
Neurodon prepping IND application for type 1 diabetes treatment
Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) application for its type 1 diabetes treatment. Crown Point, Ind.-based Neurodon’s NDC-0009 novel molecule targets endoplasmic reticulum (ER) stress, a pathway triggered by factors arising from disease that features in type 2 and type 2 diabetes, as well as inflammation […]
Senseonics stock up on Street-beating Q1
Senseonics (NYSE:SENS) shares rose today on first-quarter results that beat the consensus forecast. The Germantown, Md.-based diabetes management technology developer posted losses of -$249.5 million, or -68¢ per share, on sales of $2.8 million for the three months ended March 31, 2021, registering a massive bottom-line slide from losses of -$42.6 million this time one […]
