The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes.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 […]
Qpex Biopharma initiates Phase 1 study of oral anti-infective therapy
Qpex Biopharma announced today that it dosed the first patient in a Phase 1 study of its ORAvance inhibitor for bacterial infections. San Diego-based Qpex designed its ORAvance ultra-broad-spectrum oral beta-lactamase inhibitor for use in combination with beta-lactam antibiotics for drug-resistant gram-negative bacterial infections, according to a news release. ORAvance delivers QPX7728 in an oral […]
How PhysIQ is advancing digital therapeutics through its partnership with Janssen
Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although a return to something resembling “normal” could be on the horizon, those at artificial intelligence-based technology developer PhysIQ see […]