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CHMP Knocks Back TLC’s Doxorubicin Hybrid

Executive Summary

As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.

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CHMP Maintains Refusal Of TLC's Doxorubicin

The CHMP has confirmed its negative opinion on TLC Biopharmaceuticals’ doxorubicin hybrid. Meanwhile, Accord has received two posaconazole approvals, Zentiva has withdrawn an application for ambrisentan, and the EMA has launched a review of methocarbamol/paracetamol medicines.

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After the CHMP previously refused to recommend granting approval for TLC’s doxorubicin hybrid, the firm has asked the committee within the EMA to revisit its opinion.

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