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Sarah Faulkner

Sanofi Ventures leads $17m round for Click Therapeutics

July 23, 2018 By Sarah Faulkner

Click Therapeutics logo

Click Therapeutics said today that it landed a $17 million round, led by Sanofi‘s (NYSE:SNY)  venture arm, to fund its platform of prescription digital therapeutics. The company’s commercial product, Clickotine, is designed to help people quit smoking. The digital smoking cessation program uses a personalized plan to help people overcome tobacco cravings, adhere to medication […]

Filed Under: Featured, Funding Roundup, Pharmaceuticals, Technology, Wall Street Beat Tagged With: clicktherapeutics, Sanofi-Aventis

Roche wins CE Mark for Accu-Chek Solo insulin micropump

July 23, 2018 By Sarah Faulkner

Roche

Roche (OTC:RHHBY) said today that it won CE Mark clearance for its Accu-Chek Solo insulin micropump system. The company plans to launch a pilot commercialization phase for its device in the coming weeks in Austria, Poland, Switzerland and the U.K. Roche’s Accu-Chek Solo system features a small, tubeless insulin micropump and a remote control that incorporates […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Roche

Report: Biogen CEO eyes medical device market

July 23, 2018 By Sarah Faulkner

Biogen

After taking the helm at Biogen (NSDQ:BIIB) in 2016, Michel Vounatsos made use of acquisitions and geographic expansion to grow the company. Now, Vounatsos is reportedly considering another possible opportunity to differentiate the pharmaceutical player. The company’s chief executive hinted in an interview with Globes that Biogen could make a move into the medical technology space. “Up […]

Filed Under: Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: Biogen Idec

Takeda touts data from late-stage trial of subcutaneous ulcerative colitis therapy

July 19, 2018 By Sarah Faulkner

Takeda

Takeda Pharmaceutical (TYO:4502) touted top-line data today from its pivotal Phase III Visible 1 trial evaluating an investigational subcutaneous formulation vedolizumab as a maintenance therapy for adults with moderate to severe ulcerative colitis. The trial specifically focused on patients who experienced a clinical response at six weeks following two doses of open-label vedolizumab IV induction therapy. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Takeda Pharmaceutical Co

FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant

July 19, 2018 By Sarah Faulkner

Ocular Therapeutix - updated logo

Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Ocular Therapeutix

Abbott CEO aims for more than one million Libre users by 2019

July 19, 2018 By Sarah Faulkner

Abbott

Topping estimates on Wall Street, Abbott (NYSE:ABT) posted a hefty beat yesterday with its second-quarter financial results. Driving the company’s growth was, in part, its diabetes business unit – sales jumped nearly 40% compared to Q2 in 2017 thanks largely to its sensor-based glucose monitoring system, Freestyle Libre. “Libre offers a true mass-market opportunity with its […]

Filed Under: Diabetes, Featured, MassDevice Earnings Roundup, mHealth (Mobile Health), Patient Monitoring, Wall Street Beat Tagged With: abbott

FDA issues warning for Claris manufacturing site bought by Baxter

July 18, 2018 By Sarah Faulkner

Bax

The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month. Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter. The […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Baxter International

Novartis posts Q2 beat, promises to hold off on drug price hikes

July 18, 2018 By Sarah Faulkner

Novartis

Shares in Novartis (NYSE:NVS) were up today after the company beat expectations on Wall Street with its second-quarter financial results. The Switzerland-based company posted profits of $7.77 billion, or $3.34 per share, on sales of $13.16 billion for the three months ended June 30. Novartis saw its quarterly sales climb 7% compared with the same period […]

Filed Under: Featured, MassDevice Earnings Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Novartis

Sales for Abbott’s diabetes business jump 40% in Q2

July 18, 2018 By Sarah Faulkner

Abbott's FreeStyle Libre

Abbott (NYSE:ABT) shares were up today after the healthcare company posted second-quarter financial results that topped estimates on Wall Street. For the three months ended June 30, Abbott posted profits of $733 million, or 41¢ per share, on sales of $7.77 billion. The company saw its quarterly profits grow 159% on sales growth of 17% compared […]

Filed Under: Diabetes, Featured, MassDevice Earnings Roundup, Vascular, Wall Street Beat Tagged With: abbott

Nemaura Medical gears up to commercialize glucose monitor

July 17, 2018 By Sarah Faulkner

Nemaura Medical

Nemaura Medical (NSDQ:NMRD) said today that it placed an initial order to its UK-based contract manufacturer for 12,500 rechargeable transmitters, designed as part of the company’s sugarBeat glucose monitoring systems. Nemaura is readying for the commercial launch of its sugarBeat glucose monitor, pending CE Mark approval in the European Union. The device consists of a disposable, […]

Filed Under: Diabetes, Featured, mHealth (Mobile Health), Patient Monitoring, Wall Street Beat Tagged With: Nemaura Medical

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