Pharmaceuticals & Manufacturing

In a Complete Response Letter (CRL) sent to Ultragenyx, the FDA cited manufacturing-related concerns tied to facility processes and practices observed during inspections.

Novartis plans to introduce Coartem Baby primarily on a not-for-profit basis to improve access in malaria-endemic regions, reflecting its long-term commitment to fighting malaria.

Johnson & Johnson aims extend Akeega’s approval to include patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have homologous recombination repair (HRR) gene alterations.

Previously, Moderna’s COVID-19 vaccine (mRNA-1273) was only available for this younger age group under an Emergency Use Authorization (EUA).

The event highlighted the company’s progress in developing a fully integrated and localized AI+mRNA platform that accelerates the creation of innovative therapies, particularly in cancer and autoimmune diseases.

Under the deal, AbbVie gains exclusive rights to develop, manufacture, and commercialize ISB 2001 across major markets including North America, Europe, Japan, and Greater China.

Merck aims to enhance its respiratory portfolio with the acquisition of Ohtuvayre (ensifentrine), a newly approved inhaled treatment for chronic obstructive pulmonary disease (COPD), also known as “smoker’s lung.”

The collaboration covers several key areas including vaccine distribution, technology transfer, local manufacturing, and the development of new pharmaceutical products.

Across all three trials, efsitora demonstrated non-inferior reductions in A1C levels compared to standard daily basal insulins.