In most life sciences organizations, each function has built its own analytics environment with separate data models, ...

Testing identified significant impurity formation when tirzepatide is compounded with B12 variants, suggesting chemical incompatibility that is not evaluated under FDA review pathways. Uncertainty ...

In today's Pharmaceutical Executive Daily, Senate Democrats press major pharmaceutical companies for transparency on the terms of their most-favored-nation pricing deals with the Trump administration, ...

Early-stage biotechs must align scientific vision with capital-efficient execution, avoiding strategic thrash, building complementary teams, and designing trials that translate preclinical signals ...

Hennemand explains that Sail started in oncology but quickly pivoted to autoimmune disorders due to the suitability of RNA-based CAR T therapies. Hennemand highlights the advantages of RNA technology, ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

For full-year 2025, 58 biotech deals worth $65.9 billion were completed compared with 73 deals worth $109 billion in all of 2024. This represents a major decline in total dollar volume and the number ...

Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported adverse drug events for several of its medicines. Included in the ...

In 2025 it seemed the only certainty for biotech was more uncertainty. Biotech leaders conducted business as usual against ...

The second exit in under a year follows controversy around CRLs for Replimune and Capricor, including criticism that mid- and ...

In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law ...

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the ...