Loxo Oncology at Lilly
http://www.loxooncology.com
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Latest From Loxo Oncology at Lilly
US FDA Oncology Diagnostics Pilot Is ‘Interim Step’ To Fill VALID Void, But ‘Stuck In Neutral’
Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
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