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The Scottish Medicines Consortium has approved five new medicines for reimbursement in Scotland, including treatments for cancer, hepatitis C and diabetes. Read More
European regulators say they are prepared to start a continual assessment of data on experimental Ebola treatments as soon as they receive each submission, in an effort to speed approvals. Read More
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, will now have a centralized place to bring their ideas for advice as the agency replaces its fragmented approach to considering such concepts with a new streamlined system. Read More
The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits. Read More
The FDA has approved Eli Lilly’s Cyramza in combination with paclitaxel for advanced stomach cancer after chemotherapy, following an approval this spring as a single therapy for treating the disease. Read More
The FDA has cleared Janssen and Medivir’s hepatitis C drug Olysio to be used in combination with Sovaldi, making it the latest drug to be paired up with Gilead Sciences’ blockbuster product. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More