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Latest From FibroGen, Inc.
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.
BMS Trumpets Breakthrough For Phase III-Bound IPF Drug
Bristol Myers Squibb believes LPA1 receptor inhibition is the best approach to meet the urgent need for well tolerated new pulmonary fibrosis treatment options that can improve symptoms and address the underlying cause of disease.
Deal Watch: Gilead Grows Oncology, Inflammation Pipeline With XinThera Buy
The XinThera deal gives Gilead multiple PARP1 and MK2 inhibitors. Also, Roche licenses a HER2 kinase inhibitor from Zion, Amgen partners with TScan in Crohn’s disease and Baxter sells the last of its biopharma operations – a CDMO business – for $4.5bn.
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