Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from […]
AbbVie to buy Allergan for $63 billion
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. AbbVie will pay Allergan shareholders $188.24 per share of Allergan stock, a 45% premium to yesterday’s closing price. Humira […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up […]
Syqe Medical wins regulatory approval for cannabis drug delivery device
Syqe Medical launched its pharmaceutical-grade metered-dose cannabis inhaler in Israel after a recently regulatory approval. The Tel Aviv-based pharma-tech company spent eight years researching the inhaler technology and testing it in multiple clinical trials. Syqe Medical says the drug delivery technology could introduce complex respiration technique automation, electronic selective dosing and remote clinical monitoring and […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Inside Insulet’s pivotal year with CEO Shacey Petrovic
It’s been a busy year at Insulet (NSDQ:PODD). The diabetes tech company welcomed a new CEO, launched its first new product in six years and officially opened its $200 million global headquarters – all in the first half of 2019. That’s all the result of years of rapid growth for Insulet, chief executive Shacey Petrovic said in a keynote […]
Glaukos puts up nearly $3m to buy Dose Medical back
Glaukos (NYSE:GKOS) said yesterday that it agreed to pay nearly $3 million plus milestones to acquire former subsidiary Dose Medical and its drug-delivery technology for treating retinal diseases. Sam Clemente, Calif.-based Glaukos spun Dose out as a standalone company in 2010, but paid $26 million in July 2015 for Dose Medical’s glaucoma assets, including the cancellation […]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. The 510(k) clearance covers three Vistaseal […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn