ANDA and 505(b)(2) sponsors have been handed a boost after the FDA denied almost entirely a citizen petition filed by Bristol Myers Squibb’s Celgene which called for additional tests for rivals to its Abraxane oncology agent.
The US Food and Drug Administration has mostly denied a citizen petition filed by Celgene requesting the agency add new requirements for generic sponsors developing rivals to the originator’s Abraxane (protein-bound paclitaxel) for injectable suspension, as part of an attempt to delay competition to the complex treatment for forms of cancer.
More than six years ago, Celgene petitioned the FDA to refrain from receiving for substantive review or approving any abbreviated...
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.
