Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with Brexit. Nine months after the British people voted to leave the European Union, the government has formally started the exit process. And biotech? Biotech is feeling pretty good about its prospects. One third party affected by the exit, the European Medicines Agency (EMA), found itself in the news this week when Germany’s cost watchdog continued its attack on the adaptive pathway program. Back in the United Kingdom, London-listed PureTech took two mTORC1 inhibitors off Novartis’ hands. And the government’s innovation agency funded the creation of an antibiotic drug discovery unit. Cempra pulled an EMA filing for approval of its antibiotic solithromycin. And more.—Nick Taylor
In the run-up to the United Kingdom’s referendum on European Union membership, leaders from Big Pharmas, biotechs, academic groups and regulatory agencies based across the region warned repeatedly of the risks of Brexit. Now, two years out from the scheduled EU exit date, the tenor of the debate has shifted. Uncertainty and concerns remain, but the life science sector is increasingly confident about its post-Brexit prospects.
Novartis has offloaded two mid-phase mTORC1 inhibitors to PureTech Health. The agreement will see PureTech create a subsidiary, resTORbio, to move the assets into a phase 2b trial in diseases linked to the age-related deterioration of the immune system.
Germany’s healthcare cost watchdog is continuing to push back against the European Medicines Agency’s (EMA) plans to accelerate the approval of new medicines. The German institute worries fast-track drug approvals based on limited clinical trial data or real-world evidence will become the norm—and that this will undermine attempts to gauge the true safety and efficacy of medicines.
The United Kingdom’s innovation agency is providing funding to set up an antibiotic drug discovery unit. Innovate UK is supplying the grant to enable the University of Dundee to create a medicinal chemistry laboratory and combine it with its existing drug discovery infrastructure.
Cempra has pulled a filing for approval of its antibiotic candidate solithromycin in the European Union. The action, which comes three months after FDA knocked back the drug, was prompted by questions from the European Medicines Agency (EMA) that Cempra is currently unable to resolve.