Sen. Richard Burr, R-N.C., introduces the Federal Tobacco Bill, S. 579, to establish an agency to regulate the manufacture, marketing and use of tobacco products under the Department of Health and Human Services. The legislation is similar to the Youth Prevention and Tobacco Harm Reduction Act, H.R. 1261, introduced March 3 by Rep. Steve Buyer, R-Ind. (1"The Tan Sheet" March 9, 2009, p. 3). During an Energy and Commerce Committee markup March 4, Buyer touted his tobacco bill as an alternative to Chairman Henry Waxman's, D-Calif., Family Smoking Prevention and Tobacco Control Act, H.R. 1256, which would make tobacco an FDA-regulated product. Waxman's bill passed the committee and will move to a floor vote
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
