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Nancy Crotti

Mylan wins race for generic Advair approval

January 31, 2019 By Nancy Crotti

Mylan logo - updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Respiratory, Uncategorized, Wall Street Beat Tagged With: FDA, GlaxoSmithKline plc, Mylan, Novartis

FDA approves J&J’s Tremfya self-injection pen for psoriasis

January 30, 2019 By Nancy Crotti

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 […]

Filed Under: Auto-injectors, Drug-Device Combinations, Food & Drug Administration (FDA), Uncategorized Tagged With: AbbVie, FDA, Janssen Pharmaceuticals, johnsonandjohnson

U.S. military to adopt Adaptiiv’s 3D bolus cancer software

October 22, 2018 By Nancy Crotti

  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 […]

Filed Under: Business/Financial News, Oncology Tagged With: adaptiivmedicaltechnologies, walterreednationalmedicalcenter

Where medtech is putting its money this November

October 17, 2018 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured Tagged With: AdvaMed, Boston Scientific, centerforresponsivepolitics, Masimo, massmedic, medicalalley, medicaldevicemanufacturersassociation, Medtronic, starkeyhearingtechnologies

Rgenix raises $40M to develop novel cancer drugs

October 10, 2018 By Nancy Crotti

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 […]

Filed Under: Funding Roundup, Oncology, Preclinical Trials, Uncategorized Tagged With: rgenix

Philips’ HealthSuite will track Ypsomed’s connected self-medication devices

October 5, 2018 By Nancy Crotti

  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 […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Research & Development, Technology, Uncategorized Tagged With: Philips, Ypsomed

One Drop wirelessly connects to Apple Watch

September 12, 2018 By Nancy Crotti

One Drop

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, […]

Filed Under: Big Data, Business/Financial News, Diabetes, Technology, Uncategorized Tagged With: Apple, onedrop

Cook, AcuityBio ink deal for lung cancer drug technology

September 6, 2018 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Food & Drug Administration (FDA), Oncology Tagged With: acuitybio, cookbiotech, FDA

MicroPort’s drug-eluting stent performs well in European study

September 4, 2018 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Implants, Stents, Uncategorized Tagged With: abbott, microportscientific

Kala Pharma wins FDA nod for twice-daily ocular corticosteroid

August 24, 2018 By Nancy Crotti

Kala Pharmaceuticals

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 […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Uncategorized Tagged With: FDA, Kala Pharmaceuticals

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