Keyword: European Medicines Agency
With Brexit looming, AstraZeneca has taken up three lines of defense to forestall potential supply disruptions.
Biogen and Eisai's anti-amyloid candidate shows promise; Otsuka signs two M&A deals; Samsung BioLogics faces criminal probe over Biogen JV agreement.
Zhejiang Huahai Pharmaceutical informed the EMA that it had identified a chemical that might lead to cancer in its valsartan provided to the European market.
Gilead and Novartis CAR-T cancer drugs Yescarta and Kymriah won an EMA committee backing for marketing approval.
French regulators issued a warning letter to Indian API maker Dhanuka Labs after inspectors found a risk for product contamination.
The EMA pulled the license of Taiwan’s Savior Lifetec Corp. after a plant inspection in March turned up a variety of problems.
Indian drugmaker Theon Pharmaceuticals has been cited for falsifying records.
If its universal flu vaccine succeeds in phase 3, BiondVax aims to hustle to the European market, CEO Ron Babecoff said.
Thursday was a busy day for Europe’s regulators—and their whirl of activity will send several drugmakers into the weekend happy.
European regulators are recommending an immediate suspension and recall of AbbVie and Biogen multiple sclerosis drug Zinbryta.