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.
Asthma Drug Co-Developed by Dynavax and AstraZeneca Fails in Phase IIa Trial
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.
AstraZeneca Sells Asthma and Rhinitis Drugs to Covis
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.
Novartis plans for 60 regulatory filings during 2019-2021
Swiss pharma giant Novartis announced plans to seek regulatory approval for 60 new treatments between 2019 and 2021.
Dupixent Boosts Sanofi’s Third Quarter, Which Also Benefits Regeneron
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’s eczema product Dupixent wins FDA approval to treat asthma
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.
FDA Approves Genentech’s Xolair Prefilled Syringe Formulation
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’s Asthma Drug Looks Good in Multiple Late-Stage Trials
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.
AstraZeneca Plans to Seek Regulatory Approval for COPD Drug PT010 Following Phase III Trial
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.
GSK says U.S. FDA wants more information on pulmonary drug
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).
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February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!