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 ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...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

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 ...

Senators are probing which products fall under Medicaid-related deal provisions and whether any “MFN” prices are meaningfully lower than current Medicaid net prices after rebates.

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

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

ICON Biotech surveyed 163 biotech leaders in North America, EMEA and APAC to see how they are responding to the headwinds.

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

Under the terms of the agreement, Alfasigma is expected to acquire worldwide exclusive rights to develop, manufacture and commercialize linerixibat, while GSK will receive an upfront payment of $300 ...