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The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Citing a national opioid crisis and the frequency of deaths associated with OxyContin overdoses, a lawmaker is asking FDA Commissioner Robert Califf about how the agency administers Risk Evaluation and Mitigation Strategies for prescription opioids. Read More
It’s been a tough road for Duchenne candidates this year, with one getting rejected outright and another facing an unsympathetic advisory committee panel next Monday. Read More
The European Medicines Agency is pairing up with various governments’ policy review boards to streamline consultations with drug companies following a successful test run of the effort. Read More
Johnson & Johnson and Novartis each scored a victory in the UK, with the National Institute for Health and Care Excellence backing their respective treatments for prostate cancer and heart failure. Read More
Comments to the European Commission on proposed changes to orphan drug policy show much agreement on the need for change, but little agreement on how to make those changes. 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