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Strong sales of Biogen Inc.'s pricey spinal muscular atrophy drug, Spinraza, helped the company cruise past consensus estimates and hit record second-quarter sales on Tuesday.

FDA staffers gathered to hear advice on better balancing support for new drug development with efforts to speed access to lower-cost generics got an earful from generics companies, payers and their representatives about how loopholes, citizen petitions and market gaming have left the balance of power tilted toward innovators.

Despite some skepticism heading toward the July 21 PDUFA date, Puma Biotechnology Inc.'s breast cancer drug, Nerlynx (neratinib), won FDA approval a few days early, marking the first treatment designated as an extended adjuvant therapy in patients with early stage, HER2-positive disease.

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