Complex active ingredients, formulations, routes of delivery, and drug-device combination products are to receive greater attention as part of attempts to facilitate competition after the US FDA awarded a $5m grant to establish a dedicated research center.
Two universities in the US are to receive a five-year, $5m grant from the US Food and Drug Administration to establish a Center for Research on Complex Generics, with the aim of enhancing research collaborations with the generics industry to “further the FDA’s mission of increasing access to safe and effective generic products.”
The Universities of Maryland and Michigan are the beneficiaries of the grant, which the FDA says will help with its...
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.
