Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old
GlaxoSmithKline (NYSE:GSK) won FDA approval for the use of its Arnuity Ellipta inhaler as a once-daily therapy for the maintenance treatment of asthma in children as young as five years old. The pharmaceutical company touted its regulatory win, pointing out that the fluticasone furoate treatment is one of the only once-daily asthma therapies cleared in the […]
GlaxoSmithKline touts long-term study of biologic treatment for severe eosinophilic asthma
GlaxoSmithKline (NYSE:GSK) touted new data today from a long-term study of its biologic treatment for patients with severe eosinophilic asthma. One-third of patients treated with mepolizumab experienced no exacerbations, GSK reported – down from an average of two exacerbations each year at the start of the study. The 347-patient Columba trial gave participants 100-mg of mepolizumab […]
Here are the pharma companies accused of blocking generic competition
To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
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. […]
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