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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...

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• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.