After obtaining U.S. and European approvals this summer, Enable Injections has claimed its first regulatory green light in Japan for its enFuse wearable drug delivery technology. The country’s Ministry of Health, Labour and Welfare approved Sanofi’s push-button CirCLIQ Injector for administering a subcutaneous formulation of Sarclisa (isatuximab-irfc), a monoclonal antibody for multiple myeloma used in […]
Auto-injectors
Novo taps Nanexa for long-acting obesity injectables with €1.17B pact
Novo (NYSE: NVO) has tapped the Swedish drug-delivery developer Nanexa to develop long-acting injectable platforms for its peptide meds, with a global licensing deal worth €1.165 billion, or about $1.32 billion U.S. The deal will support up to five R&D programs targeting monthly and quarterly injections, as the drugmaker looks to extend the reach of […]
MannKind closes $50M financing, wins FDA nod for Furoscix auto-injector
MannKind (Nasdaq:MNKD) announced today that it secured $50 million in a private placement and earned a new regulatory nod. In addition to the funding, the company — which also develops inhaled insulin technology — won FDA approval for the Furoscix ReadyFlow auto-injector. MannKind said it entered into a securities purchase agreement in connection with a […]
Thermo Fisher, SHL Medical collab on drug delivery device production
Thermo Fisher Scientific today announced a strategic collaboration with drug delivery system provider SHL Medical. The collaboration coincides with the expansion of sterile fill-finish and auto-injector final assembly capacity at its Ridgefield, New Jersey site. Together, Thermo Fisher says its investments establish a fully integrated U.S.-based offering across sterile manufacturing, device assembly and commercial packaging […]
Embecta to acquire auto-injector maker Owen Mumford for up to $199.4M
Embecta (Nasdaq:EMBC) announced today that it entered into a definitive agreement to acquire Owen Mumford Holdings Limited. Owen Mumford, a privately held, UK-based company, develops and manufactures medical devices and drug delivery technologies. Embecta, the former BD Diabetes business, agreed to acquire Owen Mumford with an upfront cash payment of approximately $133 million (£100 million). […]
BD, Ypsomed to develop new syringe for biologics
BD (NYSE: BDX) and Ypsomed recently announced they will expand their collaboration through the development of a 5.5 ml version of BD’s Neopak XtraFlow glass prefillable syringe. The new BD syringe is presently in development and will undergo comprehensive testing to ensure its compatibility with Ypsomed’s YpsoMate 5.5 autoinjector platform. Syringe samples for feasibility studies […]
BD to invest $110M to support prefilled syringe production, pharma supply chain
BD (NYSE:BDX) announced today that it invested $110 million to expand its production of prefillable syringes in Columbus, Nebraska. Franklin Lakes, New Jersey-based BD aims to expand prefillable syringe production to accelerate biologic and GLP-1 drug delivery and support pharmaceutical reshoring in the U.S. The investment brings the company’s Neopak glass prefillable syringe production to […]
MannKind earns FDA nod for on-body infusor, new autoinjector patents
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients. The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month. For the on-body infusor, the FDA approved the […]
FDA accepts MannKind sNDA for autoinjector that treats edema
MannKind (Nasdaq:MNKD) announced that the FDA accepted a supplemental New Drug Application (sNDA) for its Furoscix ReadyFlow autoinjector. The Furoscix ReadyFlow autoinjector (SCP-111) was developed to deliver a subcutaneous furosemide injection as an investigational alternative to the FDA-approved Furoscix on-body infusion device for treating edema in adult patients with chronic heart failure (CHF) or chronic […]
Ypsomed launches YpsoLoop autoinjector platform designed for circularity
Ypsomed announced that it launched YpsoLoop, its first autoinjector platform designed for circularity. The Swiss drug delivery device maker says the two new 1 mL and 2.25 mL platforms enable material recovery. Their design enables automated disassembly and efficient recycling while offering the convenience of a pre-filled, two-step autoinjector. Ypsomed said the YpsoLoop platform integrates […]
