Drug Approval | June 27, 2022
Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
The 41,000 sq ft facility will be utilized to manufacture clinical to commercial-grade peptide products for increased manufacturing capacity
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Becomes first Japanese logistics company to collaborate with EMBALL’ISO, which has a proven track record in vaccine transport
The capacity addition in Suwa is part of Saint-Gobain Life Sciences ongoing investment plan to globally expand production capacity for its products and services used throughout the bioprocessing industry
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Nippon Express has provided a pharmaceutical distribution platform with strict temperature control in two ranges -- 2 C to 8 C
Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.
Operations at Oakville, Canada manufacturing plant expected to end by first quarter 2023
Construction will begin in early 2023, and the plant is scheduled to go onstream in 2025
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