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New York’s attorney general indicted a pharmacy owner, pharmacist and three pharmacies for defrauding Medicaid of $3 million in reimbursements for drugs that were never dispensed. Read More
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Read More
The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. The agency hopes to keep a majority of its existing staff in the move. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Read More
U.K. regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More