Fareva and ApiJect Systems today announced a licensing agreement to fill-finish more than 500 million injectable drug doses per year. Under the agreement, Fareva intends to invest more than $56.5 million to install three blow-fill-seal production lines with support from the Government of France through the France Relance industry initiative, as well as the Investments […]
Virpax reports positive non-human study results for topical spray film that treats chronic pain
Virpax Pharmaceuticals (NSDQ:VRPX) today reported positive results from a study of its Epoladerm treatment for chronic pain management. Berwyn, Pennsylvania-based Virpax designed Epoladerm, one of its lead investigational products, for managing pain associated with osteoarthritis of the knee. According to a news release, the company reported positive results following the completion of a toxicology and […]
Baxter touts data supporting use of machine learning for infusion pump programming
Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming. Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical […]
Inhaled drug delivery tech company Aerami to go public through SPAC merger
Aerami Therapeutics announced today that it entered into a merger agreement with FoxWayne Enterprises Acquisition Corp. (NSDQ:FOXWU). Through the definitive business combination agreement with the special purpose acquisition company (SPAC), Aerami, a developer of inhaled therapies for treating respiratory and chronic diseases, will be listed on the Nasdaq market as “Aerami Therapeutics Holdings, Inc.” According […]
Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease
Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of […]
Report: Insulet expects delays in FDA review for Omnipod 5 with launch pushed back
The highly anticipated launch of the Insulet (NSDQ:PODD) Omnipod 5 may not come as soon as thought as an FDA review drags on. SeekingAlpha reported that Insulet CEO Shacey Petrovic, speaking at the Nasdaq Investor Conference, said the regulatory agency will likely not complete its review of the next-generation Omnipod 5 before the end of […]
BD chooses ’embecta’ as new name for Diabetes Care spinoff, confirms leadership team
BD (NYSE:BDX) announced today that it named its Diabetes Care business — which it plans to spin off next year — “embecta.” Franklin Lakes, New Jersey-based BD confirmed in May that it plans to spin off its Diabetes Care business as an independent, publicly-traded company during the first half of 2022 and confirmed today that […]
Tandem Diabetes Care expands leadership team
Automated insulin delivery technology developer Tandem Diabetes Care (NSDQ:TNDM) announced new appointments in three executive leadership positions. San Diego-based Tandem named Rick Carpenter as CTO, Libba Sapitsky as SVP of Customer Care and Rizwan Pervez as SVP of Quality and Regulatory. According to a news release, Carpenter, a veteran of more than 30 years in […]
FDA grants breakthrough nod to Zetagen’s metastatic bone cancer treatment
Zetagen Therapeutics announced today that it received FDA breakthrough device designation for its ZetaMet cancer treatment technology. Syracuse, New York-based Zetagen designed its ZetaMet (previously known as ZetaFuse) as a synthetic, small-molecule, inductive biologic technology for targeting and resolving metastatic bone lesions while inhibiting future tumor growth and regenerating bone. According to a news release, […]
Bigfoot Biomedical touts cloud-based program for managing diabetes
Bigfoot Biomedical officials think their Bigfoot Unity diabetes management program and Bigfoot Clinic Hub could up the game in the space. Milpitas, California-based Bigfoot designed the Bigfoot Unity platform to allow healthcare professionals (HCPs) to review patient data. The information comes from the patient’s prescribed Bigfoot Unity system, integrating with Abbott’s FreeStyle Libre 2 continuous […]