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Latest From Threshold 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: Vertex Calls On CRISPR Yet Again, Now To Collaborate On Type 1 Diabetes
Vertex and CRISPR look beyond beta thalassemia and sickle cell disease. Also, Bicycle gets $50m up front in Novartis deal, Regeneron commits $75m initially under a Treg collaboration with Sonoma, and Jounce gets a better deal from Concentra to wave off Redx merger.
Scrip Asks…What Does 2023 Hold For Biopharma? Part 9: The Natural Environment
Improving human health is the raison d’etre of the biopharma sector. But what can the industry do to safeguard and improve the health of Planet Earth? Executives shared their thoughts with Scrip.
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