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Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems

 
• By Brenda Sandburg

BI/Lilly’s SGLT-2 inhibitor is to be manufactured in a facility that was subject to a May 2013 warning letter from FDA.

Boehringer Ingelheim GMBH has resolved deficiencies at its manufacturing plant in Ingelheim, Germany – clearing the way for FDA review of its empagliflozin NDA.

FDA cited problems at the plant in a March 5 “complete response” letter to BI and partner Eli Lilly...

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

 
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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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MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
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The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

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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.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
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Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.