PharmaJet announced today that it began enrollment for a Phase 1 clinical trial for its needle-free COVID-19 vaccine in Australia. Golden, Colo.-based PharmaJet’s needle-free injection systems will be studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Get the full story at our sister site, Drug Delivery […]
Drug-Device Combinations
United Therapeutics touts study results for inhaled Tyvaso treatment
United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment. Research Triangle Park, N.C.–based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020. Get the full story […]
Giiant Pharma extends seed round with $1.25M
Giiant Pharma announced today that it added $1.25 million to its seed financing round to ensure reaching clinical proof-of-concept for its Precision Delivery technology platform. Montreal-based Giiant’s $750,000 in funding from AQC Capital, plus $500,000 from CQDM, adds to the seed round closed last month to bring the company’s total funding to nearly $15 million. Get the […]
Medtronic touts trial results for InPen smart insulin pen, extended infusion system
Medtronic (NYSE:MDT) today presented positive study results for its InPen smart insulin pen and its extended-wear infusion set. Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM). Get the full story at our […]
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Get the full story at our sister site, Drug Delivery Business News.
Bigfoot Biomedical diabetes management program rolls out in some U.S. states
Bigfoot Biomedical announced today that made its Bigfoot Unity diabetes management program available in select U.S. markets. Milpitas, Calif.-based Bigfoot’s program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts and other New England states. The program is offered as a bundle of devices, supplies and services and delivered as a […]
FDA accepts biologics license application for Genentech’s drug-eluting eye implant
Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant standing at the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]
Kansas Distric Court rules in favor of Mylan in EpiPen class action
Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action. Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO statute, including claims […]
Teva launches first U.S. generic Perforomist inhaled COPD treatment
Teva Pharmaceuticals (NYSE:TEVA) announced the U.S. launch of the first generic version of the twice-daily Perforomist inhalation solution. Parsippany, N.J.-based Teva Pharmaceuticals — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries Ltd. — launched the formoterol fumarate inhalation solution (20 mcg/2 mL) with an indication for treating bronchoconstriction in patients with chronic obstructive pulmonary […]
Pear Therapeutics to go public via SPAC merger
Prescription digital therapeutics pioneer Pear Therapeutics announced today that it will go public by merging with a SPAC called Thimble Point Acquisition Corp. Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]