GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not […]
FDA rejects Novartis’ Advair generic, leaving GSK without rival
GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. GSK said in […]
Amiko wins CE Mark to integrate drug sensor tech into inhalers
Amiko Digital Health said today that it received CE Mark clearance to integrate its Respiro medication sensor tech with Teva Pharmaceuticals‘ (NYSE:TEVA) Spiromax inhaler, Chiesi‘s Nexthaler device and GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. The company’s Respiro platform is designed to help doctors monitor, in real-time, when and how well patients are using their medications. “Respiro’s medication […]
Verily, Sanofi and other industry players team up with NIH to advance Parkinson’s therapies
The National Institutes of Health is joining forces with the tech and pharmaceutical industries to speed the development of new drugs for Parkinson’s disease and identify biomarkers for the debilitating condition. Companies participating in the public-private partnership include Celgene (NSDQ:CELG), GlaxoSmithKline (NYSE:GSK), The Michael J. Fox Foundation for Parkinson’s Research, Pfizer (NYSE:PFE), Sanofi (NYSE:SNY) and Verily. Combined the […]
EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta. If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist. […]
NeuroMetrix, GSK ink development deal for Quell wearable pain-relief tech
Shares in NeuroMetrix (NSDQ:NURO) soared this morning after the company announced it would partner with GlaxoSmithKline (NYSE:GSK) to expand development of NeuroMetrix’s Quell wearable pain-relief device. According to the terms of the deal, GSK’s consumer healthcare business will have exclusive rights to the Quell system for markets outside of the U.S., while NeuroMetrix will retain ownership […]
GSK to use Owlstone’s breath biopsy device in Phase II COPD trial
GlaxoSmithKline (NYSE:GSK) is slated to use Owlstone Medical‘s breath biopsy device in a phase II trial of its drug for chronic obstructive pulmonary disease, danirixin. The diagnostics company’s breathalyzer will be used to help GSK identify which patients will most benefit from the drug, as well as evaluate the effects of danirixin, according to the pharma company. […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Trelegy Ellipta, […]
OncoSec Medical names new CEO | Personnel Moves – Nov. 9, 2017
OncoSec Medical (NSDQ:ONCS) announced earlier this week that the company’s co-founder, Punit Dhillon, would step down as CEO and continue to serve as president while Daniel O’Connor takes over the corner office. O’Connor joined OncoSec’s board of directors in September this year. “We are pleased to welcome Dan to OncoSec at this important time, and believe […]
Startup aims to disrupt asthma, COPD space with digital inhaler
Formed just two years ago, pharma startup Pneuma Respiratory is developing a digital inhaler that it touts as the first of its kind. The company is looking to bring its technology to the more than 40 million people who suffer from asthma or chronic obstructive pulmonary disease in the U.S. They’re stepping into a highly […]
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