Reps. Earl Blumenauer, D-Ore., and Ginny Brown-Waite, R-Fla., introduce July 30 the Tax Equity for Meal Replacements and Supplements Act of 2009. H.R. 3406 would exclude from employees' gross income employer-funded reimbursements of nutritional purchases with eligible health claims. In a release, Blumenauer said supplements can significantly improve health, and the measure can save money and reduce unnecessary doctor visits. The legislation follows a similar, broader bill introduced by Indiana Republican Rep. Dan Burton (1"The Tan Sheet" July 27, 2009). ... Tax advantages for infant formula: Health flexible spending arrangements could reimburse formula purchases for mothers with mastectomies who are medically unable to breastfeed, as part of H.R. 3445, introduced July 31 by Rep. Debbie Wasserman Schultz, D-Fla
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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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Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.