Data

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on 26 March.

Companies that fail to provide patient health data for secondary use when requested under the new European Health Data Space could be fined and also prevented from making access requests from other entities, a European Commission representative says.

INFOGRAPHIC: 2024 was a particularly quiet year for biopharma M&A, with no buyouts reaching the $5bn threshold, while alliance volume and valuations declined compared to 2023, as well.

With new Phase I/Ib results in kidney cancer, the HIF-2a inhibitor outshines Merck’s Welireg, but longtime Arcus partner Gilead decided not to exercise its option for casdatifan.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.

While the main deadline for the application of the EU’s AI Act to most AI-enabled medical technologies already regulated under the medtech regulations is 2 August 2027, various more immediate deadlines also need meeting.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader outline key compliance aspects that pharma and their global capability centers may need to factor as India moves to strengthen the framework for the protection of digital personal data.

PE firms Advent and Carlyle drove the biggest M&A deals in human and animal pharmaceuticals in India during 2024, a year that also saw Lupin strike deals with Eli Lilly and Boehringer Ingelheim to further its ambitions in the fast-growing diabetes space. Which segments look hot and what are the expected trends for deal making in 2025?