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GlaxoSmithKline plc

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

UK slaps Pfizer with record $107m fine over price hikes

December 7, 2016 By Sarah Faulkner

Pfizer

The U.K.’s Competition & Markets Authority reportedly fined Pfizer (NYSE:PFE) and Flynn Pharma a record amount for the companies’ massive price hikes to their unbranded versions of anti-epilepsy drug Epanutin. The British anti-trust 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 phenytoin sodium anti-epilepsy […]

Filed Under: Featured, Legal News, Pharmaceuticals, Policy, Regulatory/Compliance, Wall Street Beat Tagged With: Flynn Pharma, GlaxoSmithKline plc, Pfizer Inc.

GSK, Innoviva seek EU nod for triple combo inhaled therapy

December 5, 2016 By Sarah Faulkner

GlaxoSmithKline

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 […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Respiratory Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

Tests to begin for HIV therapy injections, long-acting implants

November 29, 2016 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Featured, Implants, Preclinical Trials, Research & Development Tagged With: Gilead Sciences, GlaxoSmithKline plc, Merck

GSK files for FDA approval of inhaled triple-combo therapy for COPD

November 21, 2016 By Sarah Faulkner

GlaxoSmithKline

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

Propeller wins FDA nod for connected GSK Ellipta inhaler

November 7, 2016 By Sarah Faulkner

Propeller Health, GSK

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 platform. […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), mHealth (Mobile Health), Respiratory Tagged With: GlaxoSmithKline plc, Propeller Health

BriaCell names ex-GSK exec Williams as CEO | Personnel Moves, Nov. 1, 2016

November 2, 2016 By Sarah Faulkner

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 […]

Filed Under: Featured, Oncology, Personnel Tagged With: BriaCell Therapeutics, GlaxoSmithKline plc

GlaxoSmithKline’s triple combo with Innoviva tops Symbicort Turbohaler in COPD

September 7, 2016 By Sarah Faulkner

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Research & Development Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

Struggling GlaxoSmithKline bets big on neural implants to fuel turnaround

June 10, 2016 By drugdelivery

brain-lit-up

GlaxoSmithKline‘s (NYSE:GSK) interest in tiny neural implants is stronger than ever, even amid declining earnings and flopped drug candidates that have turned CEO Andrew Witty into a lame duck who will step aside in 2017. Despite the turmoil, the British pharma giant is investing $50 million in so-called bioelectronics via Action Potential Ventures, aiming to fund companies […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: GlaxoSmithKline plc

Theravance/Glaxo's Breo Ellipta wins FDA go-ahead

May 15, 2013 By drugdelivery

Theravance/Glaxo's Breo Ellipta wins FDA go-ahead

Filed Under: Drug-Device Combinations Tagged With: GlaxoSmithKline plc, Pulmonary, Theravance

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