The European Medicines Agency (EMA) has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of this segment, may not be familiar with the regulatory process. [Read more…]
Akorn Recalls Thousands of Units of Antibacterial Due to Dissolution Issues
Akorn Pharmaceuticals is voluntarily recalling more than 362,000 units of sulfamethoxazole/trimethoprim oral suspension because the sulfamethoxazole portion doesn’t dissolve in liquid. [Read more…]
FDA Allows Intellipharmaceutics to Skip Phase III Trials of Rexista Pain Reliever
Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials. [Read more…]
Unsafe and Unapproved Drugs Continue to Be Sold in India, Study Finds
The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes. [Read more…]