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A UK-funded report is calling for drugmakers and regulators to set a goal of creating 15 new antibiotics every 10 years, at least four of which would be breakthrough products, to fight the rise in antibiotic resistant bacteria. Read More
The FDA has dubbed AbbVie’s autoimmune disease treatment Humira an orphan drug for the investigational treatment of moderate-to-severe hidradenitis suppurativa — paving the way for the drug’s ninth indication and seven years added exclusivity. Read More
The agency is inviting web developers to tap into data on adverse drug events, recalls and labeling and assess their impact for drug research Read More
The Saudi Food and Drug Authority has set strict new requirements for the import, clearance and export of commercial and investigational drugs, including provisions on drugs for compassionate use and drugs meant for use in clinical trials. Read More
Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
European generics makers are calling on the European Commission to boost job creation and economic growth in Europe by stimulating early export of generics and biosimilars to countries where no patent or supplementary protection certificates exist. Read More
The FDA is inviting web developers to tap into publicly available data on adverse drug events, recalls and labeling and assess their impact for drug research. Read More