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Bayer HealthCare Pharmaceuticals AG

Division of Bayer AG

Latest From Bayer HealthCare Pharmaceuticals AG

Pregnancy Labeling Needs Clearer, More Consistent Language, US FDA Panel Says

Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.

Advisory Committees Drug Safety

Aradigm's Linhaliq Suffers 'No' For Reducing Time To Exacerbations At US FDA Panel

Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.

Advisory Committees Drug Review

Ciprofloxacin For Bronchiectasis: Can Aradigm Avoid Bayer's Fate At US FDA Panel?

Linhaliq, an inhaled form of ciprofloxacin, appears to raise same efficacy, study design, and resistance concerns as those that resulted in a negative advisory committee review and FDA complete response for Bayer's formulation of the fluoroquinolone.

Advisory Committees Drug Review

GBCA Sponsors Must Conduct Human, Animal Studies To Assess Safety

US FDA is requiring additional safety measures related to GBCAs, but holds that there is no direct relationship established between gadolinium retention and kidney function.

Post Market Regulation & Studies Safety
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