USA – FDA draft guidance addresses use of external controls to assess effectiveness of...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...
UK – Roche’s Polivy recommended by NICE for lymphoma therapy
In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...
USA – FDA issues draft guidance on developing drugs for acromegaly
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...
USA – Experts offer CTIS advice on eve of transition for new applications
Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS)...
UK – Gilead’s CAR-T cell therapy recommended by NICE for lymphoma
Specifically, the therapy is now recommended for adult patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have...
UK – NICE recommends Alexion’s asfotase alfa across England
Alexion Pharma’s asfotase alfa – also known as Strensiq – has been recommended by the National Institute for Health and Care Excellence (NICE) for...
USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
Europe – Mandatory use of CTIS from 31 January 2023 for all new clinical...
On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications and will serve as the single-entry point...
Europe – EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next...
UK – UK to introduce new regulatory framework for point of care manufacturing
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality...
