Infectious Diseases

The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.

In 2024, trial initiations shifted following the post-pandemic decline in COVID-19 studies. Cardiovascular trials showed the greatest growth by therapeutic area but trailed the previous year’s initiation levels.

While the European Medicines Agency’s human medicines committee voted in favor of EU approval for 10 new products, it reaffirmed its previous decision not to grant Aqneursa new active substance status.

As trials of phage therapies for bacterial infections increase, the European Medicines Agency has proposed quality requirements in marketing applications for such products. Companies in this field include Locus Biosciences, Armata Pharmaceuticals, TechnoPhage, Phiogen, Medea Biopharma and BiomX.

The company is discontinuing congenital CMV development for its mRNA-1647 vaccine but still running a Phase II trial in bone marrow transplant patients.

The National Health Service said the roll out of ViiV Healthcare’s Apretude would bring England closer to its aim of becoming the first country in the world to end HIV transmissions by 2030.

The France-based firm shrugs off the disappointment of the FDA's suspension of Ixchiq.

The company announced Phase IIb results for the RSV drug that showed positive data across multiple key secondary endpoints, some of which could serve as a primary endpoint in Phase III.

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.