Francesca Bruce
Senior Writer
Latest From Francesca Bruce
Joint Clinical Assessments: EU Guidance On Evidence May Be Flexible For ATMPs And Single Arm Trials
Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
German HTA Queries Polivy Benefits Amid Lack Of Evidence
Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.
Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy
In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.
New HTA Evidence Guidelines In EU Could Spell Trouble For Advanced Therapy Companies
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.
Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee
Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.