Clik here to view.
Insulet’s Omnipod Dash system lands ISO cert for data security
Insulet (NSDQ:PODD) said this week that it won ISO 27001 certification for its Omnipod Dash product, meeting the international standard for best practice in an information security management system....
View ArticleClik here to view.
Dr. Reddy’s notches win for generic Suboxone sublingual film
Shares in Dr. Reddy’s Laboratories (NYSE:RDY) shot up yesterday after the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that blocked the company from selling a generic...
View ArticleClik here to view.
Fresenius Kabi recalls sodium chloride injections over latex concern
Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise. The company’s recall includes...
View ArticleClik here to view.
Medtronic’s insulin pumps highlighted in medtech injury report
A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that...
View ArticleClik here to view.
Valeritas touts use of insulin delivery device with physician-driven...
Valeritas (NSDQ:VLRX) touted today the publication of a retrospective analysis showing that adults with Type 2 diabetes experienced improved glycemic control using the V-Go wearable insulin delivery...
View ArticleClik here to view.
Eyenovia launches Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said today that it enrolled the first patient in the first of two Phase III trials of the company’s MicroStat program. The Mist-1 and Mist-2 trials are slated to study the safety...
View ArticleClik here to view.
FDA approves Genentech’s prefilled autoinjector for Actemra
Roche‘s (OTC:RHHBY) Genentech said today that the FDA approved its ACTPen single-dose prefilled autoinjector for Actemra as a new formulation for adults with moderate to severe active rheumatoid...
View ArticleClik here to view.
Teva launches generic EpiPen at the same price as existing device
Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s...
View ArticleClik here to view.
Eyenovia touts publication of intraocular pressure data for micro-dose tech
Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study...
View ArticleClik here to view.
Pulmatrix raises $3m in offering
Pulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at 32¢ apiece. The Lexington, Mass.-based company expects to reel in $3...
View ArticleClik here to view.
Diabeloop wins CE Mark for hybrid closed-loop diabetes management system
Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1. The Paris-based company hopes to launch its “artificial pancreas” system...
View ArticleClik here to view.
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery....
View ArticleClik here to view.
ResMed puts $225m on the table for Propeller Health
ResMed (NYSE:RMD) said today that it inked a deal to acquire Propeller Health and its digital medicine platform for $225 million in cash. Propeller Health, which sells small sensors that attach to...
View ArticleClik here to view.
Statistical error reverses noninferiority finding in head-to-head trial of...
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not...
View ArticleClik here to view.
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye...
View ArticleClik here to view.
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a...
View ArticleClik here to view.
McKesson to move HQ from California to Texas
McKesson announced that it is relocating its corporate headquarters from San Francisco to Las Colinas, Texas. The move will be effective on April 1, 2019. “We are excited to strengthen our presence in...
View ArticleClik here to view.
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that...
View ArticleClik here to view.
Novocure touts analysis of pivotal glioblastoma trial results
Novocure (NSDQ:NVCR) today touted the results of a retrospective sub-group analysis of its EF-14 Phase III pivotal trial in patients with newly diagnosed glioblastoma. The analysis, which was published...
View ArticleClik here to view.
Impel NeuroPharma raises $68m for CNS drug-device tech
Impel NeuroPharma said today that it raised $67.5 million in a Series D financing round, with investments from KKR, Norwest Venture Partners, Vivo Capital, 5Am Ventures and venBio Partners. The...
View Article