Pandemic flu: Federal preparations for and response to the H1N1 flu outbreak is funded with $7.7 billion in the 2009 supplemental appropriations bill approved by House and Senate conferees June 11. The funds are allotted to HHS, but most - $5.8 billion - will be available only on a contingency basis for critical needs. The remaining $1.85 billion, the amount provided by the original House bill and $350 million more than by the Senate bill, will be immediately available. Bill language has not been released yet, but a House staffer said the money will be divvied up according to earlier House language, which allowed financing of private vaccine production facility construction or rehabilitation (1"The Pink Sheet," May 25, 2009, p. 32). The White House requested the contingency funds June 2; final House and Senate approval on the consensus measure is expected shortly. The agreement came the same day as the World Health Organization announced that the spread of the H1N1 virus meets criteria for an influenza pandemic
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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.’
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
