CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.
Rather than creating another expedited pathway, Patrizia Cavazzoni suggested to members of Congress that the key to speeding development in neurodegenerative diseases is a better scientific understanding of the conditions.
During a 29 July House Energy and Commerce Health Subcommittee hearing on advancing treatments for neurodegenerative diseases, Chair Anna Eshoo,...
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A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
