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.
TLC Biopharmaceuticals has asked the committee for human medicinal products (CHMP) within the European Medicines Agency (EMA) to take a second look at its decision to reject the firm’s hybrid application for a liposome-encapsulated doxorubicin solution, Doxolipad.
Breast and ovarian cancer treatment Doxolipad was intended to be similar to the Adriamycin reference brand, but with the active...
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Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Following on from its recently announced US licensing deal with Amneal over its Xolair biosimilar, Kashiv has finished patient recruitment for a trial for the omalizumab candidate, paving the way for submissions.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.
