As the generics and biosimilars industries prepare for the European SPC manufacturing waiver to come into effect on 1 July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force.
On 1 July, European Regulation 2019/933 enters into force, marking the end of a long journey for the generics and biosimilars industries in its pursuit of a waiver to allow manufacturing for export outside the European Union – as well as stockpiling for day-one launch within the EU – during the term of supplementary protection certificates.
Amending the European SPC Regulation 469/2009, the waiver Regulation is the culmination of more than a decade of lobbying efforts...
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.
Also, Latest News From Europe, Canada, Saudi Arabia, Finland, China, And The US
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.
