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

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 ...

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 ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...

While pricing pressures will vary and orphan products can expect some protection now, the suggestion here is that brand planning should evaluate the merits of risk contracting for the future. At least ...

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, ...