As focus shifts to oncology, BioNTech nabs Novartis exec as chief commercial officer (Endpoints)
Prometheus team launches new startup with $400 million to tackle immune-driven disorders (STAT)
A preview of Intra-Cellular Therapies’ depression drug, and sizing up the MASH opportunity (STAT)
Catalent cuts 130 workers in Indiana; Merck KGaA to build in South Korea; Schott expands US footprint (Endpoints)
Innate ends Ph1b in peripheral T cell lymphoma; Layoffs at NextCure (Endpoints)
Exclusive: ‘If you could hallucinate a protein’: Profluent snags $35M for generative AI models (Endpoints)
Boundless Bio seeks $88M in IPO as it runs two Ph1 cancer trials (Endpoints)
Bayer says 2024 sales of prostate cancer drug above $1 bln (Reuters)
Bayer's restructuring hits pharma leadership, shifting about half of execs off top team (Endpoints)
Medtech
Where Google thinks generative AI is headed in healthcare (Endpoints)
Musk's Neuralink shows first brain-chip patient playing online chess (Reuters)
Thermo Fisher, Bayer partner to develop companion diagnostics (MedTech Dive)
US FDA classifies recall of Abiomed's blood pumps as most serious (Reuters)
Insulet names Ana Maria Chadwick CFO (MedTech Dive)
Johnson Matthey to sell medical device components unit for $700M (MedTech Dive)
Intuitive aims to keep challengers at bay with new surgical robot (MedTech Dive)
Government, Regulatory & Legal
Ex-Aegerion drug salesman avoids further prison during 2nd sentencing (Reuters)
Pharma companies and their allies seek to exempt orphan drugs from state pricing limits (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.