Viatris has bounced back from withdrawing its application for a generic version of Gilenya in the EU with a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Viatris Inc. has been backed to receive approval for a generic version of Gilenya (fingolimod) by the European regulator, a year after the firm withdrew its marketing authorization application in the EU following concerns that the company’s bioequivalence studies were “not reliable.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of an...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
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Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
