Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.

In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.

New guidelines that cast doubt over the use of single-arm and non-randomized studies are “discouraging” for rare disease patients and the advanced therapy sector, says ARM, the Alliance for Regenerative Medicines.

Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.

Industry is wary of a provision in Germany’s medical research bill that would introduce standard clauses in the contracts agreed between trial sponsors and study sites.

Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.