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Private Company Edition: As venture capital funding continues at a robust pace relative to public company financings, Knopp Biosciences and Population Health Partners launched Areteia with enough cash to fund Phase III asthma trials and Qiming revealed new VC funds totaling $2.5bn and $700m.
Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.
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.
Consumer group's languishing petition seeks class-wide REMS on risk of impulse control adverse events, such pathological gambling, hypersexuality, compulsive shopping, and binge eating caused by dopamine agonists.