Eton Pharmaceuticals, Inc.
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Latest From Eton Pharmaceuticals, Inc.
Asia Deal Watch: Ono Inks Partnerships With Switzerland’s Numab, US Biotech Shattuck
Plus alliances involving Xyphos/Kelonia, Nippon Shinyaku/Vicor, Telix/QSAM, Nicox/Kowa, Kyowa Kirin/BridgeBio, as well as deals in brief.
Deal Watch: Bayer Ties Up With Twist On Optimization Of Antibody Discovery
Plus deals involving Advanz/Dimerix, Boehringer Ingelheim/Zeiss Medical Technology, Roche/Ionis, Kriya/Everads and updates from the world of technology transfer.
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.
The Quality Lowdown: CMC Challenges Include Pfizer Unit's Quest For Injectable Acetaminophen
Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.
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