Drug Industry Daily

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Drugmakers breaking into emerging markets could see supply chain benefits and quicker product launches if these markets automatically registered FDA-approved products before testing for quality issues, according to a new study.

Cardinal Health has agreed to halt distribution of controlled substances from its Lakeland, Fla., facility for two years and firm up anti-diversion efforts as part of a settlement with the Drug Enforcement Agency (DEA), resolving claims that its controls over such drugs were too relaxed.

Vaccine makers could see better clinical trial methods and pharmacovigilance approaches come out of a proposed cooperative agreement between CBER and the World Health Organization (WHO).

Novartis is suing generic-drug makers Lupin and Torrent Pharmaceuticals after the two filed ANDAs referencing its hypertensive drug Exforge HCT.

Despite a Senate hearing Tuesday over the high price of HIV treatments, industry onlookers say any price controls on the drugs are unlikely in the near future.

Encouraged by positive Phase III results for a major depressive disorder (MDD) drug, Lundbeck and Takeda Pharmaceutical plan to file for approval with the FDA, European Medicines Agency (EMA) and Health Canada in the second half of this year.