Keyword: European Commission
When EU regulators last year came down on China’s Jinan Jinda Pharmaceutical for slipshod manufacturing work, the company brought in a U.S. consultant to get its Zhangqiu, Shandong, plant in order. Investigators say its improvement efforts still fall short of what they need to be.
Failings at an Indian CRO have tripped up Novartis and Teva as the European Medicines Agency said today that it would suspend some approved generics from the drugmakers as well as some under review.
AstraZeneca may so far be on the outside looking in with its DPP-4/SGLT2 combo when it comes to the U.S. market. On its home continent, though, it now has a first-mover advantage.
As Celgene gears up to launch Revlimid in Europe for mantle cell lymphoma, it’s already got a familiar foe waiting to receive it.
Samsung Bioepis has won approval from the European Commission for its biosimilar of Remicade, marking its second anti-TNF-α therapy in the region.
The “me-too” drug may be rehabilitated. After years of derision, the “me-too” product is getting attention from regulators as a tool for lowering drug costs--sometimes almost as much as generics.
France’s ANSM recently acknowledged it appears India's Medreich has met the goals of upgrading a plant that it banned in 2014 but won’t bother going back for the reinspection that could lead to it reinstate Medreich’s certificate of compliance.
The European Commission has granted eye care company pSivida an orphan medicinal product designation for its Medidur, which is used to treat chronic noninfectious uveitis.
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