With the US Food and Drug Administration still strained by the COVID-19 pandemic, the last thing the agency needs is a lengthy administrative proceeding that drains time and resources.
Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA
Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.
More from Pink Sheet Perspectives
• By
Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.
• By
CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.
• By
Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.
• By
Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.
More from Pink Sheet
• By
Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
• By
As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.
• By
The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.