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Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings

Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.

Drug Safety Neurology

IPF Failure Sets Back Biogen’s Diversification Efforts

The company has discontinued a Phase II trial for BG00011, which was acquired in its 2012 Stromedix purchase, due to safety issues.

Clinical Trials Business Strategies

Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line

VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.

Approvals Inflammation

Lower-Cost Competitors Hit Amgen's Blockbusters

Q1 revenue was roughly in line with expectations, but product sales were lower than consensus as multiple blockbusters faced generic competitors and biosimilars – a scenario the company prepared investors for earlier this year.

Sales & Earnings Biosimilars
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