US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...
This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report ...
FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...
Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the ...
Oncology remains the leading M&A magnet, with ASCO data catalyzing interest in new combinations and next-generation ...
Eli Lilly was attracted by a deliberately cultivated life sciences strategy anchored in a region where manufacturing ...
As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...
FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...
A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...
Valuation compression in 1H26 largely stemmed from tighter underwriting standards, with buyers resisting inflated pricing and elevating diligence thresholds rather than stepping away from high-quality ...
Kristin Ciriello Pothier, KPMG US, discusses why pharma dealmaking slowed in early 2026, but how AI partnerships, manufacturing acquisitions, and oncology are driving a second-half rebound. Kristin ...