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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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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 Meanwhile, Accord has received two posaconazole approvals, Zentiva has withdrawn an application for ambrisentan, and the EMA has launched a review of methocarbamol/paracetamol medicines.

TLC Seeks A Second Opinion On Doxolipad

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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Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex generics and biologics, even as he continues to cut staff and shut manufacturing sites as part of cost-cutting measures. In the meantime, the firm faces a “trough year” in 2019, and its profitability is continuing to suffer due to impairments including charges linked to its acquisition of Actavis in 2016.

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