Two Of Aurobindo’s Europe Biosimilar Filings Stuck, Licenses Ryzneuta From Yifan Pharma
Could MHRA Approve Bevacizumab Biosimilar Minus Phase III Trial?
Even as two biosimilar filings in Europe are stuck due to a lack of inspection staff and a biosimilar could be approved in the UK without a Phase III trial, Aurobindo has licensed novel drug Ryzneuta from Yifan Pharma. Meanwhile, a $650-700m revenue forecast for the specialty business has been pushed back as both overall revenues and profits declined during Q2.
You may also be interested in...
Months after the first generic versions of Bristol-Myers Squibb’s multi-billion-dollar blockbuster Revlimid (lenalidomide) debuted in the US, indirect purchasers of the treatment for multiple myeloma have accused the originator and a raft of settling ANDA sponsors that their deals were anticompetitive.
Among Vaxxinity’s immunotherapeutic vaccine candidates are one for Alzheimer’s that shows a 50% reduction in cognitive decline, another that shows superior durability than Pfizer and Moderna’s COVID-19 vaccines and one that could prevent migraines. Vaxxinity CEO speaks to Scrip about these and more in this interview
While generic drug prices continued to erode in the US during the second quarter of FY23, compliance will be key to the performance of Indian firms such as Torrent and Jubilant through the rest of the year. The US FDA has issued multiple observations in 2022, but an import alert for Glenmark’s Baddi unit is the harshest so far.