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To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More
After a Phase 1 trial designed by Portuguese drugmaker Bial Laboratories left one patient dead and the hospitalization of others, a committee appointed by France’s Agency for Medicines and Health Products Safety determined that an “off-target effect” of the compound is a probable explanation for the tragedy. Read More
The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection. Read More
Argentina, Brazil, Columbia and Mexico are four of the top five economies and pharmaceutical markets in Latin America, making them prime spots for drugmakers to do business. These four countries also have four of the seven agencies of reference of the Pan American Health Organization. Read More
It took Pfizer and Allergan less than 48 hours to nix their plan to build one of the world’s largest drugmakers, placing the blame squarely on the U.S. Treasury Department. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. Read More
The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization. Read More
The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans to focus on over a product’s lifecycle. Read More
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and heparin. Read More