Tandem Diabetes Care (NSDQ:TNDM) increased its full-year sales guidance, citing strong U.S. sales in the third quarter and the launch of its t:slim X2 insulin pump in international markets. The company increased its 2018 sales guidance from $140 million – $148 million to $150 million – $158 million. If Tandem posts sales within its newly-revised range, […]
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Gore adds $10m to ViaCyte investment
W.L. Gore put up a $10 million convertible note for ViaCyte and the Type I diabetes treatment they’re working on. Last year the companies inked a deal to work on the synthetic pancreas ViaCyte is developing. The San Diego-based company’s Encaptra device is designed to be seeded with stem cells engineered to become pancreatic cells and implanted under the […]
Dance Biopharm raises $24m for inhaled insulin device
Privately-held Dance Biopharm said yesterday that it raised $24.5 million in a private equity round to help fund the development of its inhaled insulin product. SternAegis Ventures was the exclusive placement agent for the offering. Molex Ventures, an electronics company working with Dance to develop a connected insulin delivery device, contributed to the round. The […]
Cook Medical wins FDA nod for 5mm Zilver PTX stent
Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. “We spend a lot of time […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]
NIH kicks off study of combo antibody HIV therapy
The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV. The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the […]
SFC Fluidics wins $1.4m grant to develop dual-hormone patch pump
SFC Fluidics said today that it won a $1.4 million grant to support the development of a dual-hormone patch pump for people with diabetes. The company’s ePump system is designed to control the delivery of insulin and glucagon via a small patch pump. The technology will also feature a flow confirmation sensor to determine, in […]
EU approves fifth biosimilar for blockbuster Humira drug
Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product. Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as […]
Clovis forks over $20m to settle SEC charges that it misled investors
The SEC said today that Clovis Oncology (NSDQ:CLVS), its CEO and former CFO will pay more than $20 million to settle charges that the company misled investors about its experimental lung cancer drug. The SEC alleged that beginning in July 2015 and over the course of a four-month period, CEO Patrick Mahaffy and his team […]
AstraZeneca touts long-term safety, efficacy data for asthma biologic
AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma. Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan. […]