FDAnews Drug Daily Bulletin

Eli Lilly’s decision to halt a mid-stage trial of its beta secretase (BACE) inhibitor drug to treat Alzheimer’s disease puts Merck’s own BACE inhibitor candidate in the lead, analysts say.

China and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive.

The FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined.

Kerala’s Pharmaceutical Manufacturers Association has decided to collaborate with businesses and academics to expand its research capabilities in the southern Indian state.

An application by Haiti on behalf of itself and other poor countries — many of which are known for their high HIV/AIDS infection rates — to extend the deadline for manufacturing generic AIDS drugs has been rejected by the World Trade Organization.

Tenofovir has been proven to reduce the risk of contracting HIV via intravenous drug use by almost 50 percent.

Pathway Genomics announced over the weekend that it intends to begin offering the BRCA genetic tests.

Spain’s royal family visited Emirati pharmaceutical manufacturer Cinfa’s facility in Spain and granted it royal endorsement.

The AARP has recently released an analysis of Pfizer’s attempts to reduce generic competition for Lipitor.