The EMA’s CHMP has recommended suspending all marketing authorizations for generics tested by Panexcell Clinical Laboratories at its site in Mumbai over inadequate data. To lift the suspension, companies relying on data from Panexcell must provide alternative data demonstrating bioequivalence.
After the discovery of irregularities in Panexcell Clinical Laboratories’ bioequivalence studies, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the suspension of all marketing authorizations for generics approved for the EU market which rely on bioequivalence studies conducted by the Indian company at its site in Mumbai.
A list of 34 affected medicines authorized or pending approval based on Panexcell trials was published by the EMA....
Also, Latest News From Europe, Canada, Saudi Arabia, Finland, China, And The US
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.
