Azurity Pharmaceuticals, Inc.
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Latest From Azurity Pharmaceuticals, Inc.
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.
Deal Watch: Lilly Teams Up With Lycia In Protein Degradation
Lilly hopes to address immunology and pain indications with biotech’s LYTAC technology. Sunovion licenses European rights to Parkinson’s therapy Kynmobi to Bial.
Deal Watch: BMS Looks To Molecular Templates’ Engineered Toxin Bodies In Cancer
Plus recent deals involving AbbVie/Caribou, Sanofi/i2O, Merck & Co./Starpharma, Protalix/SarcoMed, Targovax/Papyrus, Medivir/Ubiquigent, Eton/Azurity
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