Whitehall-Robins' vitamin/mineral/herbal combination product increases levels of plasma vitamin E, folic acid and vitamin B12, M.H. Davidson, Chicago Center for Clinical Research, et al., report in poster to be presented at Federation of American Societies for Experimental Biology meeting in Orlando, Fla. March 31 to April 4. Results of the 12-week, double-blind, placebo-controlled study involving 161 people indicate "key nutrients are well absorbed from this formulation, which improved cardiovascular risk factors [such as] elevated homocysteine and low density lipoprotein susceptibility to oxidation," researchers conclude. Homocysteine levels decreased 17.2% in active arm compared to mean increase of 3.2% in placebo arm. Centrum Heart Focused Formula contains vitamins B6, B12 and E, folate, selenium, manganese, garlic powder, taurine and coenzyme Q10. Study was funded in part by Whitehall-Robins
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.