Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
Pharmaceuticals
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. 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 set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]
Vaxxas raises $23M for needle-free drug delivery tech
Vaxxas announced today that it completed a financing round that brings in $23 million (A$34 million) in new funds. Existing investors OneVentures and UniQuest led the round. New investors, including members of the Vaxxas board and management team, along with individual investors, participated. The company earmarked proceeds to advance its clinical programs, including its needle-free […]
BD opens $38.6M medication management manufacturing plant in Mexico
BD (NYSE:BDX) announced recently that it inaugurated a new $38.6 million manufacturing facility in Tijuana, Mexico. Government officials from Mexico and the state of Baja California joined in the opening of the medication management plant. BD plans for the facility to produce devices and technologies that improve medication safety within healthcare settings. According to a […]
PharmaJet wins NIH grant to evaluate needle-free delivery of HPV immunization
PharmaJet announced today that it received a grant worth $800,000-plus from the NIH to evaluate its needle-free injection system. Golden, Colorado-based PharmaJet picked up a Phase II grant from the NIH (National Institutes of Health). It allows the company to evaluate the immunogenicity of the intradermal administration of human papillomavirus virus (HPV) vaccine. The study […]
Bionaut Labs closes $43M Series B for robotic drug delivery tech
Robotic drug delivery technology developer Bionaut Labs announced today that it closed a Series B financing round worth $43.2 million. Los Angeles-based Bionaut Labs uses microscale robots to deliver drugs for treating central nervous system (CNS) diseases and disorders. Through magnetic propulsion, the company’s Bionauts can navigate the human body and deliver drugs locally. The […]
Oramed inks deal to commercialize oral insulin in the Republic of Korea
Oramed Pharmaceuticals (Nasdaq:ORMP) announced today that it entered into a distribution agreement for its oral insulin candidate in the Republic of Korea. The New York-based developer of oral drug delivery platforms entered into an exclusive commercial distribution agreement with Medicox. The agreement covers the distribution of ORMD-0801 in the Republic of Korea (formerly South Korea). […]
Enable Injections to add hundreds of jobs in Ohio
Enable Injections announced today that it committed to increasing jobs and payroll in the Cincinnati, Ohio region. The company intends to add 257 jobs and nearly $20 million in payroll in Cincinnati by 2027. Ohio’s Tax Credit Authority Board approved the commitment today. It allows the company to benefit from Ohio’s Job Creation Tax Credit […]
Rani Therapeutics launches RT-111 development program
Robotic pill company Rani Therapeutics (Nasdaq:RANI) has begun developing RT-111, a RaniPill GO capsule containing a biosimilar of Johnson & Johnson’s (NYSE:JNJ) Stelara (ustekinumab). The company anticipates that RT-111 could potentially treat psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis. The FDA first approved Stelara in 2009 for psoriasis. Stelara is available in intravenous and […]
BD, Biocorp partner on connectivity for self-administered injectable drugs
BD (NYSE:BDX) announced that it entered into an agreement with Biocorp with the aim to use connected technology with injectable drugs. The companies seek to track adherence for self-administered drug therapies, including biologics. They plan to integrate France-based Biocorp’s Injay technology with BD’s UltraSafe Plus passive needle guard. Biocorp designed Injay to capture and transmit […]
