FDA approves Mylan’s generic Advair
The U.S. Food and Drug Administration approved Mylan NV’s generic version of the GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher.
The U.S. Food and Drug Administration approved Mylan NV’s generic version of the GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher.
Dynavax Technologies shares fell more than 5 percent after the company reported that an asthma drug being jointly developed with AstraZeneca failed to meet endpoints in a mid-stage trial.
As AstraZeneca focuses on a strategy of divesting assets and spending on the product pipeline, the biopharmaceutical company sold rights to three older drugs to Covis Pharma for $350 million.
Swiss pharma giant Novartis announced plans to seek regulatory approval for 60 new treatments between 2019 and 2021.
Nearly two weeks after the U.S. Food and Drug Administration approved Sanofi and Regeneron’s Dupixent as an add-on maintenance therapy for moderate to severe asthma, the France-based company reported a surge in sales for the medication in the third-quarter 2018 report.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.
AstraZeneca released positive results from the BORA Phase III extension clinical trial of Fasenra (benralizumab) as an add-on maintenance therapy in patients with severe eosinophilic asthma that had already completed either the SIROCCO or CALIMA Phase III trials.
Following a setback in a chronic obstructive pulmonary disease (COPD) clinical trial in August, AstraZeneca unveiled data from a separate trial that showed the triple combination therapy PT010 outperformed dual-therapy rivals eight of nine times.
GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).