1. Pink Sheet

Bristol Likes What It Sees In Five Prime, Invests More In CSF1R Program

 
• By Jessica Merrill

Bristol agreed to pay $350m upfront for global rights to Five Prime’s CSF1R antibody program, including FPA008, in a deal that builds on the companies’ previous clinical collaboration agreement.

Bristol-Myers Squibb Co. is upping its commitment to Five Prime Therapeutics Inc. and the antibody developer’s colony stimulating factor 1 receptor (CSF1R) antibody program with a new global licensing deal announced Oct. 15.

The deal replaces an existing clinical collaboration between the two companies signed in November 2014 to study Five Prime’s lead CSF1R antibody FPA008 in combination with Bristol’s PD-1 inhibitor Opdivo (nivolumab) in six cancer indications, suggesting the two companies want to move even more aggressively to develop

More from Clinical Trials

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.