A combination drug-device therapy developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. […]
FDA delays safety data reporting deadline for combination products
The FDA last month gave companies that make combination products an extra year to submit safety data to the federal safety watchdog. The new guidelines call for firms making drug-device combinations to submit individual case reports to the FDA’s Adverse Events Reporting System and electronic Medical Device Reporting system by July 31, 2020. Vaccine adverse […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for […]
Medtronic, BCBS Minnesota ink value-based diabetes deal
Medtronic (NYSE:MDT) said today that it inked a deal with Blue Cross & Blue Shield of Minnesota on an outcomes-based program for diabetes patients. The plan gives BCBS Minnesota members access to Medtronic’s Guardian Connect continuous glucose monitor via a pharmacy benefit, with payments pegged to how long patients spend in a targeted blood glucose […]
Johnson & Johnson touts drug-releasing lens studies for itchy eyes
Contact lenses imbued with an antihistamine drug reduced itchy eyes in a pair of older studies funded by the vision business at Johnson & Johnson (NYSE:JNJ), the company said today. The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens […]
Baxter ticks up on Q4, 2018 beats
Baxter (NYSE:BAX) beat Wall Street’s consensus forecast with both its fourth-quarter and full-year results, to tepid reaction from investors, who sent the healthcare giant’s share price up a hair today. Deerfield, Ill.-based Baxter posted a return to black ink for the three months ended Dec. 31, 2018, logging profits of $348 million, or 65¢ per share, […]
NovoCure slides on Q3 sales miss
NovoCure (NSDQ:NVCR) shares took a hit today, despite lower-than-forecast losses, after the company reported financial results that missed expectations for third-quarter sales. NVCR shares were down-12.7% to $36.23 today in late-morning trading on the news. Get the full story on our sister site, MassDevice.com.
Johnson & Johnson closes $2B LifeScan sale
Johnson & Johnson (NYSE:JNJ) said today that closed the $2.1 billion sale of its LifeScan blood glucose monitoring subsidiary to private equity player Platinum Equity. The sale is part of the New Brunswick, N.J.-based healthcare conglomerate’s move to get out of the device end of the diabetes business. Early last year J&J announced a strategic review of the LifeScan, Animas […]
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 […]
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 […]
