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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PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More
Former InterMune CEO W. Scott Harkonen’s crusade to challenge his felony conviction in a closely watched free speech case collapsed after the Supreme Court declined to hear his appeal. Read More
French authorities on Thursday fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
Amarin has received an FDA untitled letter for omitting risk information in a print promotion for its fish oil drug Vascepa, adding to a pileup of setbacks for the product. Read More
Eli Lilly and Acrux on Nov. 12 filed suit against Actavis to prevent the generic drugmaker from commercializing a generic version of the testosterone topical solution Axiron. Read More