Latest News & Analysis
Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.
Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.
The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.
The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.
Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.
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