Entries by Thomas Gabrielczyk

SPC manufacturing waivers: A blow to innovation?

The EU’s Big Pharma companies have sharply criticised the European Parliament’s Legal Committee JURI backing of an amended proposal of the European Commission (EC) to introduce a supplementary protection certificates (SPC) manufacturing waiver. Under the waiver, EU-based biosimilar and generics makers would be allowed to export copycat drugs during the SPC period that adds five years of additional IP protection to the 20 years of patent duration.

Sotio on track for 2nd Phase III trial

After positive preliminary results of Sotio’s SOV02 trial in ovarian cancer had been presented last year, the final analysis confirmed the survival benefits. The Czech biotech company now plans to initiate a global Phase III study with its autologous cell-based immunotherapy also in this indication.

Financing AMR innovation discussed globally

Financing of AMR innovation is shifting gears in early 2019. US AMR accelerator CARB-X has expanded its global reach, the Novo REPAIR impact fund reflects on their first and upcoming investments, and the British Government is underway to take first steps for a pull mechanism this year. During the Novel Antimicrobials and AMR Diagnostics conference in mid-March in Berlin, 300 international AMR experts will discuss the status quo.