EMA

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include nine new products, one of which is Kostaive (zapomeran), CSL/Arcturus Therapeutics’ self-amplifying mRNA COVID-19 vaccine for individuals 18 years and older.