GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
In 2017, GlaxoSmithKline ended its partnership with Ionis Pharmaceuticals, Inc. to develop and market inotersen and a follow-up drug for rare diseases. After reviewing its options, Ionis has signed a worldwide license deal to Akcea Therapeutics for inotersen and AKCEA-TTR-LRx in a deal that could hit $1.7 billion. What makes this deal a bit unusual is that Akcea is a subsidiary of Ionis.
Investors who pressed GlaxoSmithKline to slash new CEO Emma Walmsley’s pay package before she took the helm probably won’t much like her overall compensation figure for 2017.
SBRI Healthcare alumni and Cambridge-based Owlstone Medical has announced that it has raised $15 million (£11 million) to drive the global commercialisation of its Breath Biopsy® platform.
GSK touted phase 3 data of its quadrivalent flu vaccine Fluarix Tetra. As a severe flu season continues to unfold in the U.S., GlaxoSmithKline is touting phase 3 study data showing its Fluarix Tetra can protect young children who are among the most vulnerable to the virus.
GlaxoSmithKline’s meningitis B vaccine Bexsero is in a class all by itself when it comes to snagging the Breakthrough Therapy Designation from the U.S. Food and Drug Administration(FDA).
London-based startup accompanying U.K. Prime Minister on trade mission
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
AstraZeneca has GlaxoSmithKline and its chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta squarely in its sights. This morning, AstraZeneca revealed Phase III data that shows its experimental three-in-one inhaler PT010 improved lung function in patients.
Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, announced the completion of a $49.5 million Series A financing to further build its technology platform and advance its lead programs toward clinical development.
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