AirFluSal’s Decentralized Approach to EU Shields Seretide From Exposure
This article was originally published in The Pink Sheet Daily
Sandoz’ AirFluSal Forspiro has been approved in Germany, but the company’s decentralized route into Europe means that GSK’s Seretide is somewhat shielded from all-out competition.
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In addition to patent expiries, which affected pharma company performance globally, ongoing price cuts for drugs and increasing parallel trade continued to hurt pharma’s European performance in the second quarter, with the gloom unlikely to lift soon. What’s at stake is further pharma investment in Europe.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.