In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

Public-market performance improved across pharma and biotech, with mid/small-cap biotech significantly outperforming, supporting refinancing flexibility and moderating private-valuation pressure ...

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 ...

In 2025 it seemed the only certainty for biotech was more uncertainty. Biotech leaders conducted business as usual against the background of ongoing funding challenges and ever-increasing drug ...

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, ...

Internal criteria allowed cancelling adverse event reports when reporters believed events were unrelated to therapy, conflicting with FDA requirements to submit serious, unexpected events irrespective ...

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

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 ...

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

FDA granted Priority Review to AstraZeneca’s supplemental application for Enhertu in early-stage HER2-positive breast cancer, moving the drug closer to a potential new indication for patients at high ...