Cogentix Medical (NASDAQ: CGNT) said today that it invested $2 million in privately-held Vensica Medical and its ultrasound-based, needle-free drug delivery device, VensiCare. Israel-based Vensica Medical is developing its VensiCare device as a way to deliver botulinum toxin to treat overactive bladder. The company also has IP for the delivery of oncology agents to the […]
Drug-Device Combinations
Tandem touts adoption of CGM update to t:slim X2 insulin pump
Last month, Tandem Diabetes Care (NSDQ:TNDM) announced that the FDA approved its t:slim X2 insulin pump integrated with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The San Diego, Calif.-based company made the software available to its current t:slim X2 pump users at no additional cost, enabling them to add CGM-integration to their existing devices. Today, the company reported […]
SteadyMed requests meeting with FDA over rejected application for drug-device combo
Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the […]
FDA deals setback to Intarcia for diabetes implant
Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes. The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter. Intarcia hinted that the reason behind the […]
Baxter launches asset tracking system for infusion pumps
Baxter (NYSE:BAX) today launched the DeviceVue asset tracking solution for hospitals using its Sigma Spectrum infusion system. The product was designed to help clinicians and biomedical engineers quickly find unused pumps by viewing pump location and status data from their computers or phones. The company said it is the first and only smart infusion pump manufacturer to […]
China OKs Novo Nordisks’ once-daily Tresiba basal insulin
Novo Nordisk (NYSE:NVO) said today that its once-daily insulin degludec won approval from the China Food and Drug Administration. The insulin-maker’s product is designed to be a once-daily basal insulin with an ultra-long duration of action for people with diabetes. “There are more adults with diabetes in China than anywhere in the world, and we are […]
Bellerophon nabs $23m in private placement
Bellerophon Therapeutics (NSDQ:BLPH) said today that it inked a deal with new and existing investors to raise $23.4 million in a private placement of common stocks and warrants. The financing was led by Puissance Capital Management and Venrock Healthcare Capital Partners, supported by existing investors like New Mountain Capital and Linde North America, the Warren, N.J.-based […]
Engage Therapeutics raises $23m Series A for drug-device seizure therapy
Summit, N.J.-based Engage Therapeutics said today that it closed a $23 million Series A round to fund a Phase IIb trial of its lead product, Staccato alprazolam. The round was led by TPG Biotech, Adage Capital Management and Lumira Capital. The drug-device product combines a hand-held inhaler technology, which is FDA-approved, with alprazolam, an FDA-approved […]
Aspire Capital to acquire $20m worth of Valeritas stock
Valeritas (NSDQ:VLRX) said today that it inked a deal with Aspire Capital Fund to buy $20 million of Valeritas’ common stock. According to the deal, Aspire Capital is slated to purchase common stock at Valeritas’ request from time to time during a 30-month period at prices based on the market price at the time of each […]
pSivida partners for sustained-release glaucoma drugs
pSivida (NSDQ:PSDV) said today that it inked a deal with an unnamed global pharmaceutical company to develop two glaucoma drugs with pSivida’s sustained-release technology. The partnership includes $750,000 worth of upfront payments for initial development and the potential for $200,000 in additional payments contingent upon subsequent development activities, according to the Watertown, Mass.-based company. “A key […]