The FDA plans to standardize electronic drug applications and other regulatory submissions over the next five years and will release a host of guidances in 2014 and 2015 to implement the standardization. Read More

French authorities have fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More

U.S. lawmakers Dec. 11 introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

The generics industry enters uncharted territory in 2014 as it adjusts to a landscape altered by monumental Supreme Court rulings in 2013 and the FDA’s proposed rule to authorize generic drugmakers, for the first time, to change product labeling in response to safety signals. Here’s an overview of the significant events that happened in 2013 and how they promise to shape the industry in 2014 and beyond. Read More

Pernix Therapeutics’ promotional webpage for its bronchitis drug Cedax has drawn an untitled letter from the FDA for making misleading claims and omitting risk information. Read More

2014 will look a lot like 2013 for the pharma industry, analysts say, with patent expirations and cost-containment policies, especially in the EU, depressing revenue growth. Read More

Negotiators overseeing a civil suit related to last year’s nationwide outbreak of fungal meningitis say they have reached a tentative settlement with the Massachusetts compounder linked to the outbreak that could see victims and creditors receive more than $100 million. Read More

Covis Pharmaceuticals has received an FDA untitled letter for making unsubstantiated superiority claims and omitting vital risk information about its heart drug Lanoxin in a physician letter. Read More

PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More

GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More

HHS stands by its final rule expanding 340B discounts to orphan drugs when certain hospitals and healthcare providers use them to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More