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EPR’s news round-up 2019: the stories that defined the year
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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US Food and Drug Administration (FDA)
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Dr Stephen Hahn appointed as new FDA commissioner
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
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Drug approved which reduces risk of cardiovascular events
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
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Regulatory submissions made for dispersible formulation of dolutegravir
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
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Report links greater generic competition and lower generic drug prices
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
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FDA grants accelerated approval for treatment of rare DMD mutation
The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.
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The global cannabinoid pharmaceutical industry
Cannabinoids are of growing interest in the pharmaceutical industry. Mark Tucker explains how this class of compounds is viewed across the world and why regulations surrounding them hinder their progress, yet remain necessary.
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Consumers told not to use drugs recalled from Basic Reset and Biogenyx
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
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FDA grants Orphan Drug Designation to Epidermolysis Bullosa treatment
The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
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The first generics of Gilenya have been approved by the FDA
The first three applications for generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of MS have been approved.
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Zotiraciclib granted Orphan Drug Designation by FDA and EMA
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
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FDA update: additional testing of ranitidine and nizatidine ordered
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
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FDA updates guidance for adaptive clinical trial reporting
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
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Priority Review granted to pemigatinib for treatment of cholangiocarcinoma
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
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The FDA has approved Exservan™ for the treatment of ALS
The FDA has granted early-action approval to Exservan for the treatment of ALS, which can be administered safely and easily without water.
