Regulatory Index News: 13/02/2018

Welcome to your Regulatory Index News digest today. Take a look here for your biweekly update.

FDA rejection for Novartis' Advair generic

The FDA have turned down Novartis’ Abbreviated New Drug Application (ANDA) for an Advair generic to treat asthma. The rejection has lowered the chance of a generic entering the US market this year, with Novartis stating that it is “highly unlikely” that their copy will be launched this year after receiving the Complete Response Letter from the FDA. This marks a third rejection from the FDA for an Advair generic, with the others for Mylan NV and Hikma Pharmaceuticals plc. This is down to the complex nature of the drug development, where the manufacturer must develop a copy of the drug, as a well as the delivery device. Whether a generic makes it to market this year has a large effect on the anticipated earnings of the Advair innovator, GlaxoSmithKline (GSK), where forecast earnings per share for 2018 are set to grow between 4-7% without a generic but less than 3% if there was. Please click here to read more on this from a BioPharmaDIVE article.

ViiV Healthcare initiate Phase 3 study of two-drug HIV regimen

The HIV specialist has announced the start of a Phase 3 trial known as TANGO, to analyse whether HIV positive adults with virologic suppression on a TAF-based regimen with atleast three drugs, are able to maintain viral suppression when switched to a two-drug regimen of Tivicay and Epivir. This will be achieved by investigating patient satisfaction along with long-term anti-viral activity, tolerability and safety of the two-drug regimen. The trial aims to enrol approximately 550 adults with HIV-1 in North America, Europe, Australia and Japan. It is thought that if the two-drug treatment is able to maintain viral suppression, then it may help in reducing the number of medicines required by patients as well as long-term toxicity. If you would like to read more, please click here for a PharmaTimes article.

Technetium-99m isotope manufacture brought back to US following FDA approval

Technetium-99m (Tc-99m) is used in the vast majority of medical diagnostic tests, with over 80% of nuclear medicine imaging using it in the US. It allows healthcare professionals to better understand the internal environment of patient organs and how diseases such as cancer are affecting them. The FDA have now approved the manufacture of this isotope through a RadioGenix System, which is expected to restore domestic supply for the first time in 30 years and lower the risk of supply shortages. It has been noted that Tc-99m shortages and threats of shortages lead to doctors using other isotpes which are more costly and potentially dangerous, this new approval is hoping to stop that. Please click here to read further from a BioPharmaDIVE article.



Max Lymbery

Date Published

13th February 2018

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