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With the launch of the FDA’s new Office of Pharmaceutical Quality, all ANDA filers are now eligible for the OPQ’s new real-time communications program – the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
Drug companies will find more payers refusing to reimburse for cancer drugs if they don’t reduce their prices, pharmacy benefits manager Express Scripts says. Read More
Tekmira Pharmaceuticals is merging with OnCore BioPharma in an effort to develop a cure for hepatitis B and corner a potentially lucrative market. Read More
India appears intent on mending its reputation as being unfriendly to foreign drug patents, with a court temporarily blocking Cipla from marketing its own generic version of Novartis’ COPD therapy Onbrez. Read More
Dendreon has not demonstrated that its prostate cancer drug Provenge provides enough benefit over less expensive drugs to justify reimbursement, UK healthcare cost watchdog said this week. Read More
Shire will pay $5.2 billion to acquire rare disease manufacturer NPS Pharma, the latest acquisition aimed at boosting the Irish drugmaker’s rare disease portfolio. Read More