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 […]
Milestone Scientific appoints new CEO following FDA nod | Personnel Moves – July 13, 2017
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 […]
Braeburn names former Teva exec as new president, CEO | Personnel Moves – June 14, 2017
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 […]
Pieris, AstraZeneca ink $45m deal for inhaled respiratory drugs
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 […]
Novo Nordisk puts $145m into U.K. research center
(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 […]
Adherium’s smart inhaler tech chosen for EU mobile health program
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 […]
GSK, Innoviva seek EU nod for triple combo inhaled therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S. The triple combination therapy is […]
GSK files for FDA approval of inhaled triple-combo therapy for COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that GSK filed a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. The triple-combo therapy includes 3 drugs: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; vilanterol, a long-acting beta2-adrenergic agonist. The medicines […]
AstraZeneca, Bespak ink deal for metered-dose inhaler
AstraZeneca (NYSE:AZN) said last week that it inked a multi-year commercial supply deal with Consort Medical (LON:CSRT) subsidiary Bespak for its pressurized metered-dose inhaler technology. Bespak will supply inhaler valves and actuators for use with AstraZeneca’s inhaled aerosol treatment for chronic obstructive pulmonary disease. AstraZeneca won FDA approval in April for the aerosol, Bevespi Aerosphere […]
GlaxoSmithKline’s triple combo with Innoviva tops Symbicort Turbohaler in COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease. The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol. Patients in the FF/UMEC/VI […]
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