Regulatory Index News: 07/12/2017

Welcome to your Regulatory Index News update for today. Please have a read here for the latest industry updates from around the globe.

US approval for Novo’s Ozempic

The FDA have given Novo Nordisk the approval for their once-weekly glucagon-like peptide (GLP)-1 agonist, Ozempic, to treat patients with type 2 diabetes. The drug, also known as semaglutide, was approved as a prefilled pen device which can hold either 0.5mg or 1mg. As part of the marketing requirement, Novo Nordisk will be conducting a trial in patients under the age of 18. The drug will also be added to the 15-year medullary thyroid carcinoma (MTC) registry that is being conducted for all GLP-1s. This approval comes at a good time for Novo Nordisk to maintain their market lead in the GLP-1 space as Victoza, their once-daily treatment, was being threatened by longer acting treatments from competitors. Please click here if you would like to read further from a BioPharmaDIVE article.

Safety concerns rise for Dengvaxia as Sanofi is ordered to pull out of the Philippines

There have been rising concerns with Sanofi’s Dengue vaccine after suspending school-based immunizations and releasing an advisory about the risks of the shot in patients with no prior Dengue infection. Now however, the Philippines’ FDA have ordered the complete withdrawal of Dengvaxia from the market and to conduct an information dissemination campaign with communications to doctors and patients. The World Health Organisation (WHO) have also reacted by publishing a notice that it is conducting a full review on Dengvaxia and advises that it is only administered to subjects which have previously been infected with Dengue. If this story interests you, please follow the link here to a FiercePharma article.

Opdivo taken to China

Bristol-Myers Squibb have released data from their phase 3 trial, that they have now cut short, which shows that Opdivo improved overall survival in lung cancer when compared with docetaxel. Based on those results, the drugmaker has taken their immune-oncology drug to China, filing an application to the Chinese FDA for the hopeful approval of first-line lung cancer treatment. This is a big opportunity for BMS to bring the first non-small cell lung cancer treatment to China where lung cancer is the most commonly diagnosed cancer with over 733,000 new cases in 2015. If you would like to read more on this new filing, please click here for an article from FiercePharma. 

M L

Author

Max Lymbery

Date Published

07th December 2017

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