Europe – Actions to support the development of medicines for children
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and...
Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the...
On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a...
USA – FDA releases FY 2022 generic drug research summary
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year...
USA – FDA draft guidance addresses clinical development of drugs to treat early Lyme...
The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs...
USA – FDA draft guidance addresses use of external controls to assess effectiveness of...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Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...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In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated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USA – FDA issues draft guidance on developing drugs for acromegaly
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...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...
