Pharming Group N.V.
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Latest From Pharming Group N.V.
Trials In Focus: Diverse Enrollment Lagging In Oncology, IQVIA Finds
Also, CRO Syneos Health appointed an executive to its newly created DE&I position, while Alterity started a new Phase II study in multiple system atrophy, Antabio dosed the first patients in its Phase I study of an antibiotic for hospital infections, and Structure Therapeutics started a Phase IIa trial of its GLP-1 agonist in obesity and diabetes, with plans for a Phase IIb trial in 2024.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
Asia Deal Watch: Aditum Bio Launches Vitalli To Develop Daewoong Immunology Candidate
In addition, deals involving Lupin/Medisol, Junshi/Dr. Reddy's, Zai Lab/MediLink, Kyowa Kirin/ADVANZ, Ipca/Unichem, Jiangsu Aidea/Kainos.
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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