Regulatory Index News w/c 04 November 2019

Here is a selection of this week's news from around the world


Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout

The storied biotech is going out with a bang, however, with plans to release pivotal trial results for its leading cancer cell therapy lisocabtagene maraleucel, or liso-cel. Securing FDA approval of the drug by the end of 2020 is an essential step to its investors receiving $6 billion more from buyer Bristol-Myers Squibb. 

To read more follow this BioPharmaDive link


FDA grants Sandoz approval for Ziextenzo in oncology care

The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this year.

To read more follow this PharmaTimes link


EMA validates Braftovi, Mektovi application for some mCRC

The European Medicines Agency (EMA) has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for BRAFV600E-mutant metastatic colorectal cancer (mCRC). The combination, which also includes cetuximab, has the potential to be the first chemotherapy-free, targeted regimen for patients with advanced colorectal cancer if it is approved.

To read more follow this PharmaTimes link


As fateful FDA review nears, Amarin makes case for Vascepa

Amarin CEO John Thero said Tuesday he expects an expert Food and Drug Administration panel to challenge the company with "intentionally tough" questions on clinical data supporting the company's request for an expanded approval of its fish oil-based drug Vascepa. 

To read more follow this BioPharmaDive link


Biogen broadens biosimilar bet to go after top-selling eye drugs

Biogen will expand its efforts to sell copycat versions of top-selling biologic drugs, expanding a partnership with Korean developer Samsung Bioepis to cover two in-development biosimilars of the eye disease drugs Lucentis and Eylea.

To read more follow this BioPharmaDive link


J&J submits EMA applications for Ebola vaccine

Johnson & Johnson has announced the submission of Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen. The company’s Janssen division is seeking license for the drug for the prevention of Ebola Virus Disease (EVD) specifically caused by Zaire ebolavirus species.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

08th November 2019

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