Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the ...
As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...
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 ...
FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...
FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza antiviral access and introducing a new competitor to the branded product ...
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 ...
The US Pharmacopeia’s 2025 annual drug shortages report found that while the total number of shortages declined by 23% in ...
USTR framed German payer discounts as an unfair R&D free‑ride and signaled tariffs could be avoided via negotiated price commitments, mirroring the recent UK NHS arrangement. Tariffs on US-bound ...
A comprehensive approach to long-term sustainability efforts in pharmaceutical manufacturing should prioritize simpler frameworks that curb costs, risks, and variability.
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