Drug makers beat diabetes lawsuits with an unusual ruling

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Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines. In a 35-page ruling, US District Court Judge Anthony Battaglia explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed.

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 4, 2020

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Article | March 4, 2020

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Pfizer Won’t Win the Coronavirus Pharma War

Article | March 4, 2020

Shares of Pfizer jumped more than 6% on Wednesday, after the company announced a plan to test some of its antiviral products as a potential treatment for the coronavirus from China. More than 35 million shares traded on the news — about 48% more than normal — as investors looked for any positive news from the pharma community after the recent selloff. So, does this mean that Pfizer stock is turning the corner?

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Do Clinical Trial Delays Mean Trouble for Pharmaceutical Stocks?

Article | March 4, 2020

Pharmaceutical stocks have been somewhat of a safe haven for investors as the coronavirus outbreak spread from China to the rest of the world. But as the pandemic deepened, now resulting in more than 782,000 cases worldwide, even these "safer" companies are beginning to feel the effects. The U.S. is now the coronavirus epicenter, with the most cases -- more than 161,000 as of today. Initial concerns for drugmakers had to do with the supply of active pharmaceutical ingredients, which often come from China. The worry was that pharmaceutical companies wouldn't be able to produce enough of their drugs for patients.

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Real Regulatory Ltd

Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

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