GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults. The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not […]
Judge adds $10m in damages in Vectura-GSK patent spat
This article has been updated with a statement from Glaxo Smith Kline. A federal judge in Delaware has awarded British inhaler company Vectura an additional $10.5 million in compensatory damages from Glaxo Smith Kline (NYSE:GSK) in a patent dispute. In May, a jury awarded Vectura $89.7 million in damages for the period from August 2016 through December 2018 for an infringement […]
Vectura seeks another $44M in GSK patent win
Fresh off its $89.7 million jury award in a patent infringement case against GlaxoSmithKline (NYSE:GSK), British inhaler company Vectura has petitioned the court for an additional $44 million. On May 16, a jury in U.S. District Court for the District of Delaware awarded Vectura damages for the period from August 2016 through December 2018 for an infringement […]
Thermo Fisher to buy Irish drug manufacturing site from GSK for $101m
Thermo Fisher Scientific‘s (NYSE:TMO) said today that it inked a deal to acquire a Cork, Ireland-based drug substance manufacturing site from GlaxoSmithKline (NYSE:GSK) for approximately $100.6 million (EU €90 million). Waltham, Mass.-based Thermo Fisher said that the acquisition of the new site will allow it to expand capacity and meet customer demand for both the development and […]
Vectura wins $89.7m in patent infringement case against GlaxoSmithKline
Vectura said this week that it has settled a U.S. patent infringement litigation with GlaxoSmithKline and was awarded $89.7 million in damages. Following a jury trial in the U.S. District Court for the District of Delaware, Ventura was awarded damages for the period from August 2016 through December 2018 for an infringement on Vectura’s U.S. […]
Innoviva-GSK project Trelegy Ellipta meets main endpoint in asthma pivotal trial
A combination drug-device therapy developed by GlaxoSmithKline(NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. The 2,436-patient Captain trial […]
Touting pricetag, Mylan launches Advair generic
Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. Get the full story at our sister site, Drug Delivery […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than […]
NeuroMetrix lands $4m milestone payment from GSK deal
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., in exchange for […]
FDA rejects Mylan’s Advair generic in win for GSK
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 […]
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