Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan
The latest news about products accepted into US FDA expedited review programs.
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Public Company Edition: Also, Teva sells $2.1bn in notes to pay prior debts. In restructurings, Baudax splits off from Recro, while three firms shift their focus to specific cell therapy programs.
Full data at ESMO show Opdivo managed to scrape a tolerability edge over standard-of-care sorafenib in liver cancer, but eyes were drawn to Roche’s early study of Tecentriq/Avastin as the way forward in this difficult-to-treat cancer.
Allergan Inc. and AstraZeneca plc will join forces to further develop and commercialize ATM-AVI, a fixed-dose antibiotic for the treatment of infections caused by metallo β-lactamase (MBL)-producing Gram-negative pathogens – bacteria for which there are few viable antibiotics.