The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Source: International Pharmaceutical Regulatory Monitor
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data…
Japanese drugmaker Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues. Source: International Pharmaceutical Regulatory Monitor
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Source: International Pharmaceutical Regulatory Monitor
While retail prices for cancer drugs may be the highest in the U.S., these medicines appear to be less affordable in poorer countries such as India and China despite their…
A new report out of the UK this week recommends monetary incentives to induce drugmakers to develop vaccines for drug-resistant infections. Source: International Pharmaceutical Regulatory Monitor
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement in June, but left the door open to further discussion.…
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Source: International Pharmaceutical Regulatory Monitor
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Source: International Pharmaceutical Regulatory Monitor