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GlaxoSmithKline plc

Janssen touts topline data for long-acting, injectable HIV therapy

November 2, 2018 By Sarah Faulkner

Janssen updated logo

Johnson & Johnson‘s (NYSE:JNJ) Janssen touted topline results this week from a Phase III trial of its long-acting, injectable two-drug regimen for the treatment of HIV. The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: GlaxoSmithKline plc, janssen, johnsonandjohnson

NeuroMetrix lands $4m milestone payment from GSK deal

August 23, 2018 By Sarah Faulkner

NeuroMetrix Quell

NeuroMetrix (NSDQ:NURO) said this week that it reeled in a $3.8 million milestone payment from its collaboration with GlaxoSmithKline‘s (NYSE:GSK) consumer healthcare unit. The strategic deal between the two groups was first announced in January this year. According to the terms of the deal, GSK acquired exclusive ownership of NeuroMetrix’s Quell pain-relief device outside the U.S., […]

Filed Under: Featured, Funding Roundup, Pain Management, Wall Street Beat Tagged With: GlaxoSmithKline plc, neurometrix

Sage Therapeutics’ chief scientist on discovering drugs and taking risks

June 29, 2018 By Sarah Faulkner

Sage Therapeutics

When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk. But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), […]

Filed Under: Discovery, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: GlaxoSmithKline plc, Novartis, Pfizer Inc., sagetherapeutics, Sanofi-Aventis

FDA rejects Mylan’s Advair generic in win for GSK

June 14, 2018 By Sarah Faulkner

Mylan

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Mylan, Novartis

GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old

May 21, 2018 By Sarah Faulkner

GlaxoSmithKline

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 […]

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

GlaxoSmithKline touts long-term study of biologic treatment for severe eosinophilic asthma

May 21, 2018 By Sarah Faulkner

GlaxoSmithKline

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc

Here are the pharma companies accused of blocking generic competition

May 17, 2018 By Sarah Faulkner

Pills

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Wall Street Beat Tagged With: Actelion Pharmaceuticals, Celgene, FDA, Gilead Sciences, GlaxoSmithKline plc, Johnson & Johnson, Novartis, Valeant Pharmaceuticals

AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers

April 9, 2018 By Sarah Faulkner

Owlstone Medical's breath biopsy device

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 […]

Filed Under: Clinical Trials, Diagnostics, Drug-Device Combinations, Featured, Pharmaceuticals, Research & Development, Respiratory, Wall Street Beat Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Owlstone Medical

GSK seeks expanded label for Trelegy Ellipta inhaler in EU

February 14, 2018 By Sarah Faulkner

GlaxoSmithKline

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

FDA rejects Novartis’ Advair generic, leaving GSK without rival

February 8, 2018 By Sarah Faulkner

GlaxoSmithKline

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Novartis, sandoz

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