Latest from Nancy Pham
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The Department of Government Efficiency cancelled leases for FDA office and lab space at numerous sites outside the Washington, DC, area, while many buildings on the agency’s White Oak, MD, campus were included on the General Services Administration’s initial list of “non-core” government properties for disposal.
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.
CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.
Review times for all 61 novel agents the US FDA approved in 2024.
In this instalment of HBW Insight’s “Inside Regulatory Affairs” series, AdverCheck managing directors Lucy Rochford and James Walmsley describe how the consumer health industry is increasingly outsourcing its advertising copy review as it moves closer to the fast-moving consumer goods sector. They also point to a worrying trend in the UK of advertising prescription-only medicines online.