Good morning, everyone, and nice to see you again after we took an extended holiday break. Of course, we are now playing a game of catch-up as we attempt to rifle through thousands of emails and digest the flood of news over the past several days. To cope, we are firing up the trusted coffee kettle to brew a few cups of stimulation. Our choice, so far, is coconut hazelnut. Please feel free to join us. Meanwhile, we have managed to find a few tidbits to help you adjust as you settle in. We hope your transition is manageable and your day glides along splendidly. As always, do keep in touch. We appreciate any and all efforts to keep us apprised of important events. …
The U.K. government is poised to agree to a major deal with the Trump administration that will mean zero U.S. import tariffs on pharmaceutical products and lead to an increase in National Health Service medicines spending, The Times of London reports. The deal follows months of protracted negotiations amid intense criticism and pulled U.K. investments from multinational drugs companies. Under the agreement, expected to be announced over the coming days, the U.K. is understood to have agreed to lower an industry sales rebate rate on NHS drug prices and to also improve the NHS cost-effectiveness measure for drugs. The so-called quality-adjusted life year tracks the cost of a treatment for every healthy year it delivers for a patient. The measure is used by the National Institute for Health and Care Excellence when deciding whether to recommend a new drug. The threshold is set to be increased by about 25%.
The U.S. Food and Drug Administration’s top vaccine regulator asserted in an email sent to agency staff that the Covid-19 vaccine caused at least 10 deaths in children and called for changes to the way the agency regulates vaccines. But experts are skeptical of the memo’s “extraordinary” claim because it was not presented with detailed data, STAT explains. Vinay Prasad, who heads the FDA Center for Biologics Evaluation and Research, wrote that regulatory requirements for new vaccines would be heightened as a result of the deaths. But it is unclear what the next steps will be. The memo does not contain information on plans to release more detailed information on the deaths or to publish the result in a medical journal. Prasad said the agency would require more definitive data for vaccines administered during pregnancy and that he plans to reform the way that annual influenza vaccines are regulated. He also stated that the FDA may look at whether multiple shots should be given at once, a concern that could disrupt the childhood vaccine schedule.
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