EMA

A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.

Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the EU marketing application from the European Medicines Agency for the closely-watched chronic obstructive pulmonary disease drug.

Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the file from the EMA for the closely-watched chronic obstructive pulmonary disease drug.

Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.

Generics manufacturers have succeeded in overturning a decision awarding Biogen an extra year of market exclusivity for its multiple sclerosis brand Tecfidera.

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

A busy month for the EMA’s Committee for Medicinal Products for Human Use saw nine biosimilars recommended for approval.

The EMA is reviewing the IL-23-targeting oral peptide which the company claims will transform the plaque psoriasis treatment paradigm.

The Swiss giant is paying $30m upfront for rights to the Swedish firm’s BrainTransporter technology, its second brain-barrier breaching deal in as many months.

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.