Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
Hampton joins PCC from Accord Healthcare, where he was the President and responsible for accelerating the firm's growth strategy
The superior Agilent 6495 Triple Quadrupole LC/MS (LC/TQ) System is ideal for demanding and challenging targeted analysis applications requiring the highest analytical sensitivity
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
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