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European Medicines Agency Advises Gene Therapy Developers on Regulatory Requirements

May 22, 2015 By MedNews Leave a Comment

The European Medicines Agency (EMA) has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of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…]

Filed Under: Drug Industry News Tagged With: European Medicines Agency (EMA), Gene Therapy

Akorn Recalls Thousands of Units of Antibacterial Due to Dissolution Issues

May 22, 2015 By MedNews Leave a Comment

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…]

Filed Under: Drug Industry News Tagged With: Akorn Pharmaceuticals

FDA Allows Intellipharmaceutics to Skip Phase III Trials of Rexista Pain Reliever

May 22, 2015 By MedNews Leave a Comment

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…]

Filed Under: Drug Industry News Tagged With: Intellipharmaceutics, Pain Management, Rexista

Unsafe and Unapproved Drugs Continue to Be Sold in India, Study Finds

May 22, 2015 By MedNews Leave a Comment

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…]

Filed Under: Drug Industry News Tagged With: Anelgesics, Antipsychotics, India

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