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US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products

 
• By Bridget Silverman

From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.

gonorrhea bacteria. Alamy - 2CBCWKP
• Source: Alamy

The particular exigencies of gonorrhea have the US Food and Drug Administration seeking input on current thinking just five years after the agency issued a final guidance document.

The FDA joined with the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Disease...

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New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

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New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.