FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had […]
FDA approves J&J’s Tremfya self-injection pen for psoriasis
FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis. The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients. Made by J&J subsidiary Janssen Pharmaceuticals (Horsham, Penn.), Tremfya is a biologic therapy that selectively […]
U.S. military to adopt Adaptiiv’s 3D bolus cancer software
Adaptiiv Medical Technologies said that the U.S. military will use its 3D bolus software to treat American veterans with cancer at Walter Reed National Military Medical Center. Adaptiiv designed its software to convert patient CT scan data into a digital model that can be used to print a bolus that conforms to patient anatomy, according to […]
Where medtech is putting its money this November
Republicans reaped nearly $3.3 million in federal political contributions from the medtech industry in the 2017-18 election cycle, compared with $1.85 million for Democrats, according to data collected by the Center for Responsive Politics, a nonprofit campaign finance watchdog group. Medtech has “historically been a little more Republican than the average industry,” said Andrew Mayersohn, committees […]
Rgenix raises $40M to develop novel cancer drugs
Biopharma startup Rgenix said it has raised $40 million in Series C financing to further develop its clinical and pre-clinical oncology programs and for general corporate purposes. New York City-based Rgenix has discovered several novel RNA-regulated cancer targets that drive tumor growth and cancer progression, according to its website. These targets regulate key components of […]
Philips’ HealthSuite will track Ypsomed’s connected self-medication devices
Philips and Ypsomed said today that they will jointly develop a solution for Ypsomed’s new self-medication adherence monitoring services based on Philips’ HealthSuite digital platform. The combination of Ypsomed’s connected devices and Philips’ (NYSE:PHG) cloud-based digital platform will allow Ypsomed’s pharmaceutical customers to deliver value-added services aimed at improving patient outcomes, the companies said in […]
One Drop wirelessly connects to Apple Watch
One Drop said today that its wireless blood glucose monitoring system can now connect directly to Apple Watch, making it the first diabetes company’s system to do so. One Drop was also the first such company to launch a companion Apple Watch app, but until now, users had to manually log blood glucose, food, medication, […]
Cook, AcuityBio ink deal for lung cancer drug technology
Cook Biotech will collaborate with drug-delivery maker AcuityBio on Acuity’s lead lung cancer product, the companies said today. Acuity’s ABC103 will use Cook Biotech’s proprietary extracellular matrix (ECM) technology. ABC103 is a platform technology designed for localized, sustained drug delivery to prevent post-surgical lung cancer recurrence. It combines approved/ cleared surgical staple-line buttress, drug-eluting polymers and […]
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus […]
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company. While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid […]