Certara Gets Further FDA Grant For Virtual Bioequivalence Studies
US Agency Offers Funding To Verify And Expand Biosimulation Models
The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.
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Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.
Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.