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Biggest overhaul of UK clinical trial regulation for 20 years

Drug Discovery World

These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the UK one of the best countries in the world to conduct clinical research. The post Biggest overhaul of UK clinical trial regulation for 20 years appeared first on Drug Discovery World (DDW).

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Researchers map how the brain regulates emotions

Science Daily: Pharmacology News

A new study is among the first of its kind to separate activity relating to emotion generation from emotion regulation in the human brain. The findings provide new insights that could help inform therapeutic treatments regarding mental health and drug addiction.

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Japanese regulator reviews first-line bladder cancer combination

Drug Discovery World

The post Japanese regulator reviews first-line bladder cancer combination appeared first on Drug Discovery World (DDW). The US Food and Drug Administration approved the combination therapy in December 2023. It is also under review with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

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Drug discovery trends: From regulation to embracing AI

Drug Discovery World

This is the latest episode of the free DDW narrated podcast, “Drug discovery trends: From regulation to embracing AI”, which covers two articles written for Volume 23 – Issue 4, Fall 2022 of DDW. Listen here: The post Drug discovery trends: From regulation to embracing AI appeared first on Drug Discovery World (DDW).

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National PFAS water regulations imminent

Agency IQ

BY WALKER LIVINGSTON, ESQ The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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UK regulator approves Pfizer/BioNTech’s adapted Covid-19 vaccine

Drug Discovery World

Applications to regulators have included pre-clinical data showing that the Omicron XBB.1.5-adapted The post UK regulator approves Pfizer/BioNTech’s adapted Covid-19 vaccine appeared first on Drug Discovery World (DDW). The updated Covid-19 vaccine aims to further improve protection against severe illness and hospitalisation.”

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Scientists call for tighter regulation of stem cell treatments

Drug Discovery World

Scientists are calling for tighter regulation of stem cell treatments, claiming clinics worldwide are offering unproven ‘therapies’ for conditions as varied as hair loss and Parkinson’s. They are calling on regulators to halt these products until they can be proven safe and effective in clinical trials.