The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
PolarityTE launches two chronic wound treatment trials
PolarityTE (NSDQ:PTE) said it has begun enrolling patients in two new randomized clinical trials of its SkinTE regenerative tissue product for chronic wounds. The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin […]
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]
Mylan wins race for generic Advair approval
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 […]
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