Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps
Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
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Dr. Reddy’s compliance woes hit a new low, with the German regulator stopping supplies to the EU from the firm’s Bachupally unit over significant GMP deviations. Worse still, some foreign investor rights law firms appear to be pressing for a class action suit against the company.
Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.