Enable Injections announced today that it received FDA approval for its enFuse injector for the delivery of Empaveli. Empaveli, commercialized by Apellis Pharmaceuticals, treats adults with paroxysmal nocturnal hemoglobinuria (PNH). The injector — in this case, called the Empaveli Injector — offers self-administration of the pharmaceutical. The compact, wearable device streamlines the self-administration experience with […]
Pharmaceuticals
Abbott: Real-world data indicates GLP-1s could be accelerator for FreeStyle Libre
New real-world data from Abbott (NYSE:ABT) demonstrates a potentially positive impact of GLP-1 drugs on diabetes technology. GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss. The drug class continues to […]
Satio wins $3.5M contract to develop at-home transdermal drug delivery device
Satio announced that a National Institutes for Health agency awarded it a $3.5 million Small Business Innovation Research (SBIR) contract. Awarded by the NIH’s Advanced Research Projects Agency for Health (ARPA-H), the contract helps the company develop SatioRx. This drug delivery device, compact and inexpensive, features disposable microneedle components for precise delivery. It remotely enables […]
FDA requests more info on neffy needle-free epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) says the FDA issued a complete response letter (CRL) regarding its neffy epinephrine nasal spray. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company initially set an anticipated target action date of mid-2023 for its PDUFA […]
Vaxess raises $9M to support shelf-stable vaccine patch
Vaxess Technologies announced today that it raised an additional $9 million in venture capital funding to support its vaccine delivery technology. Cambridge, Massachusetts-based Vaxess develops a shelf-stable vaccine patch with the potential for self-application. The company’s MiMix system features sustained-release technology for administering vaccines and therapeutics. For vaccines, its controlled release simulates the pace of […]
Analysts: GLP-1 drugs should have minor impact on insulin pump market — but will boost CGMs
Based on conversations with diabetes experts, analysts are playing down the potentially negative impact of GLP-1 receptor agonists on the diabetes technology industry. The GLP-1 drug class, which includes Ozempic and Wegovy, has cast a shadow of doubt over diabetes technology of late. This therapeutic class, a glucagon-like peptide 1, has proven to lead to […]
Emergent BioSolutions launches over-the-counter Narcan nasal spray
Emergent BioSolutions (NSYE:EBS) announced today that it plans to put its over-the-counter Narcan nasal spray on U.S. shelves next month. FDA approved the over-the-counter Narcan spray in May. Approval enabled direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod came about six weeks after an agency committee voted unanimously in favor […]
Vaxxas wins $3.7M award to support needle-free typhoid vaccine tech
Vaxxas announced that it received a $3.67 million award to conduct studies of a typhoid vaccine delivered by its needle-free device. The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to the […]
BioCorRx submits implantable opioid use disorder treatment to FDA for expanded access
BioCorRx announced today that it submitted to the FDA an expanded access program application for its BICX104 implantable naltrexone pellet. BICX104, a biodegradable implantable pellet, treats opioid use disorder (OUD). The expanded access program would enable the treatment to reach eligible patients before full FDA approval. The FDA program provides access to products before approval […]
Emergent BioSolutions to cut 400 jobs, focus on Narcan nasal spray
Nasal Narcan spray maker Emergent BioSolutions (NSYE:EBS) announced a change in strategy and investment that affects 400 jobs. The Gaithersburg, Maryland-based company decided to reduce investment in and de-emphasize focus on growth in its CDMO business. This results in a reduction of operations at the company’s Bayview facility in Baltimore. Additionally, in response to changes […]
