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AstraZeneca plc

AstraZeneca wins FDA nod to remove boxed warning from asthma drug label

December 21, 2017 By Sarah Faulkner

AstraZeneca

After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product. Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk […]

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

FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo

October 23, 2017 By Sarah Faulkner

AstraZeneca Bydureon

AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs. The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to […]

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

Oral drug delivery startup raises $39m for robotic pill

September 13, 2017 By Sarah Faulkner

San Jose, Calif.-based Rani Therapeutics has some seriously big-name backers: Alphabet (NSDQ:GOOGL), Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have all invested in the startup. This month, the company raised $38.7 million as part of a $126.5 million offering of equity and options or warrants, according to an SEC filing. So far, 12 investors have contributed to the offering. Rani […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals, Wall Street Beat Tagged With: alphabet, AstraZeneca plc, Novartis, ranitherapeutics

Adherium launches next-gen monitor for AstraZeneca’s Turbuhaler

September 13, 2017 By Sarah Faulkner

Adherium Ltd. (ASK:ADR) said today that it launched a next-gen version of its SmartTurbo adherence monitor for AstraZeneca‘s (NYSE:AZN) Turbuhaler. The company’s monitor features usability improvements to make the device’s installation and removal easier for older patients with COPD. It also includes larger buttons to help patients access features like audio and visual reminders, battery monitoring […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Adherium, AstraZeneca plc

Adherium wins 510(k) clearance for smart inhaler monitoring device

September 1, 2017 By Sarah Faulkner

adherium

Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and […]

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

Milestone Scientific appoints new CEO following FDA nod | Personnel Moves – July 13, 2017

July 13, 2017 By Sarah Faulkner

Milestone Scientific

Milestone Scientific (NYSE:MLSS) said this week that it appointed Daniel Goldberger to the company’s corner office. Leonard Osser, who previously served as CEO, is slated to remain on the board and will continue to serve as director of Milestone’s China operations. The appointment comes on the heels of the FDA’s decision to grant Milestone’s CompuFlo epidural […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: AstraZeneca plc, Avalon, Biogen Idec, cingulatetherapeutics, foamixpharmaceuticals, Gamida Cell, Ipsen, mannkind, milestonescientific, Novaliq GmbH, portal instruments

Braeburn names former Teva exec as new president, CEO | Personnel Moves – June 14, 2017

June 14, 2017 By Sarah Faulkner

Braeburn Pharmaceuticals

Braeburn Pharmaceuticals said last week that it named Michael Derkacz as president and CEO of the buprenorphine implant-maker. Most recently, Derkacz worked as senior VP and head of global central nervous system and pain therapeutic areas for Teva Pharmaceuticals (NYSE:TEVA). Behshad Sheldon, who helped to found Braeburn in 2012, is slated to step down from Braeburn […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: alexionpharmaceuticals, AstraZeneca plc, Biogen, Boston Scientific, Braeburn Pharmaceuticals, ctibiopharma, cytrx, Dicerna Pharmaceuticals, GlaxoSmithKline plc, Merrimack Pharmaceuticals, Novartis, Ocular Therapeutix, Sanofi-Aventis, Teva Pharmaceuticals, uniqure

Pieris, AstraZeneca ink $45m deal for inhaled respiratory drugs

May 3, 2017 By Sarah Faulkner

Pieris Pharmaceuticals

Pieris Pharmaceuticals (NSDQ:PIRS) inked a $45 million deal with AstraZeneca (NYSE:AZN) to develop a group of inhaled drugs for respiratory diseases. According to the deal, Pieris will get $45 million up front to bring an experimental asthma drug into human clinical trials. The drug is slated to begin Phase I testing this year, which will […]

Filed Under: Drug-Device Combinations, Featured, Respiratory, Wall Street Beat Tagged With: Allergan, AstraZeneca plc, pierispharmaceuticals, Roche

Novo Nordisk puts $145m into U.K. research center

January 30, 2017 By Sarah Faulkner

Novo Nordisk

(Reuters) – Novo Nordisk, the world’s top maker of diabetes drugs, is investing 115 million pounds ($145 million) in a new research center in Britain, undeterred by Brexit. The Danish company said on Monday it would invest the money over 10 years in the center based at the University of Oxford, which will employ 100 […]

Filed Under: Diabetes, Featured, Pharmaceuticals, Research & Development, Wall Street Beat Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Novo Nordisk

Adherium’s smart inhaler tech chosen for EU mobile health program

December 12, 2016 By Sarah Faulkner

adherium

Adherium Ltd. (ASK:ADR) said today that its Smartinhaler was chosen for the myAirCoach program as a part of the European Union’s Horizon 2020 Framework for Research and Innovation. The Horizon 2020 program is the largest EU research and innovation program ever established, with €80 billion (nearly $85 billion) of funding available from 2014 until 2020. The […]

Filed Under: Drug-Device Combinations, Featured, mHealth (Mobile Health), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Adherium, AstraZeneca plc, GlaxoSmithKline plc

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