While pharmaceutical companies and medical device firms know that working together is a vital part of doing business, they “live in 2 different world in many ways,” Minnetronix co-founder Dirk Smith said last week at the annual Drug Delivery Partnerships conference. From development timelines to regulatory approval pathways, it can sometimes seem like pharma and medtech companies are […]
GlaxoSmithKline plc
GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma. The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s […]
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 […]
UK slaps Pfizer with record $107m fine over price hikes
The Competition and Markets Authority reportedly fined Pfizer (NYSE:PFE) and Flynn Pharma a record amount for the companies’ massive price hikes to its unbranded versions of the anti-epilepsy drug, Epanutin. The British competition watchdog fined Pfizer and Flynn Pharma $107 million (£84.2 million) and $6.5 million (£5.2 million), respectively. New York City-based Pfizer used to market the anti-epilepsy […]
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 […]
Tests to begin for HIV therapy injections, long-acting implants
Drugs from companies such as GlaxoSmithKline (NYSE:GSK), Gilead Sciences (NSDQ:GILD) and Merck (NYSE:MRK) are reportedly being considered for large-scale trials evaluating injectable HIV prevention therapies. Eventually, researchers hope to produce matchstick-sized implants that could provide year-long protection to vulnerable populations. Foster City, Calif.-based Gilead has a once-daily pill, Truvada, which prevents HIV infection during sex. Pre-exposure prophylaxis, also known […]
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 […]
Propeller wins FDA nod for connected GSK Ellipta inhaler
Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler […]
BriaCell names ex-GSK exec Williams as CEO | Personnel Moves, Nov. 1, 2016
BriaCell Thereapeutics (CVE:BCT) said last week that it named biotechnology veteran Dr. William Williams as its president & CEO effective Nov. 1. The Berkeley, Calif.-based company’s lead product is a genetically engineered, whole-cell vaccine derived from a human breast tumor cell line. BriaCell suggests that the vaccine may be able to trigger the immune system to […]
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 […]
Verily, GlaxoSmithKline partner to form $713m joint Galvani Bioelectronics
GlaxoSmithKline (NYSE:GSK) said today it is partnering with Google‘s (NSDQ:GOOG) Verily to form Galvani Bioelectronics, a new firm focused on bioelectronic medicine. Bioelectronic medicine operates around using miniaturized, implantable devices, much like neuromodulation devices, designed to modify electrical signals through nerves for a variety of different effects, including pain relief and chronic condition management, the company […]