While the introduction of joint clinical assessments under the new EU HTA Regulation could be “fruitful,” the bloc should take a more “integrated approach” to enabling access to ATMPs, according to a Belgian HTA expert.
EU-wide joint clinical assessments (JCAs), a key part of the Health Technology Assessment (HTA) Regulation, will not solve all access problems faced by EU citizens who are eligible for treatment with an advanced therapy medicinal product (ATMP).
This is according to Jo De Cock, former general administrator for the Belgian HTA body RIZIV-INAMI, who spoke during a...
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
